What You'll Do

We’re looking for a Contracts Counsel to lead drafting, review, and negotiation of a broad range of agreements. You’ll be a primary legal partner to several business teams, helping scale contracting processes, accelerate deal cycles, and manage risk with practical, business-friendly guidance.

Responsibilities

• Independently draft, review, and negotiate a wide variety of agreements, including master services agreements, statements of work, clinical trial agreements, consulting agreements, quality agreements, NDAs, SaaS/technology agreements, data processing/security addenda, and other vendor/commercial and/or research contracts
• Serve as day-to-day counsel to affiliates and cross-functional stakeholders (e.g., Procurement, Finance, Clinical, Quality, IT/Security, HR, and business teams), advising on contract structure, risk allocation, and negotiation strategy
• Triage contract requests and drive matters through intake, approvals, execution, and repository/CLM workflows; keep deals moving while maintaining consistency with company policies
• Identify and manage key issues (indemnities, limitation of liability, IP ownership/licensing, confidentiality, data privacy/security, insurance, termination, audit rights, subcontracting, compliance)
• Partner with InfoSec/Privacy and other SMEs to align contractual obligations with internal controls (e.g., security requirements, incident response, vendor assessments)
• Act as a strategic stakeholder in the development of processes, systems, and training to support contract lifecycle management
• Develop and maintain templates, fallback positions, playbooks, and process guidance; proactively spot patterns and reduce repeat friction in negotiations
• Support governance, audits, and reporting on contracting volume, cycle times, and risk trends; help train internal teams on contracting best practices
• Coordinate with outside counsel as needed and manage scope/costs

Where You'll Work

This is a hybrid role with in-office collaboration 2x per week in our San Francisco and/or Palo Alto Offices.

Who You Are

• J.D. from an accredited law school and active bar membership in at least one U.S. jurisdiction
• 4–6 years of relevant experience, including at least 2 years at a law firm, with substantial hands-on responsibility negotiating commercial contracts
• Preferred experience in life sciences/biotech/pharma and/or other regulated industries
• Have strong drafting/redlining skills and proven ability to manage negotiations independently
• Have willingness to use and incorporate AI tools on a routine basis
• Organized, responsive, and comfortable managing multiple priorities in a fast-paced environment
• Experience with contracts in the life sciences industry, such as sponsored research and clinical trial agreements
• Experience building contracting infrastructure (templates, playbooks, CLM workflows and tools) and partnering closely with Procurement

The role:

The Vice President of Biometrics will provide strategic and operational leadership across statistical activities as the company transitions into Phase III clinical trials. This role will be responsible for defining and executing the integrated biometrics strategy, overseeing CRO and vendor partnerships, ensuring data integrity and regulatory readiness, and serving as a key leader on the clinical development team. The ideal candidate brings deep late-stage expertise, strong cross-functional leadership, and a hands-on mindset well suited for a lean, fast-growing biotech organization.

Key responsibilities:

• Provide strategic leadership for biometrics across all clinical development programs, with primary focus on Phase III execution
• Define and implement an integrated biometrics strategy supporting clinical trial design, data quality, statistical analysis, and regulatory submissions
• Serve as a core member of the clinical leadership team, partnering closely with Clinical Operations, Data Management, Regulatory Affairs, Safety, and Medical Affairs
• Lead and oversee CROs and external vendors responsible for biostatistics statistical programming and related biometrics activities.
• Oversee development and review of key deliverables including SAPs, DMPs, CRFs, TFL shells, interim analyses, database locks, and clinical study reports
• Ensure data integrity, statistical rigor, and compliance with GCP, ICH, and global regulatory requirements
• Provide strategic input into study design, endpoint selection, sample size calculations, and adaptive or innovative trial methodologies as appropriate
• Support regulatory interactions and submissions, including briefing documents, responses to health authority questions, and advisory committee preparations
• Establish scalable biometrics processes, standards, and SOPs to support late-stage development and future pipeline growth
• Build, mentor, and lead internal biostatistics capabilities over time, as appropriate to company growth

Required experience & skills:

• Bachelor’s degree or advanced degree, ideally in biostatistics, statistics, mathematics, or a related quantitative discipline
• Minimum of 12 years of progressive experience in biostatistics within the biotechnology or pharmaceutical industry
• Significant experience leading biostatistics activities for Phase III clinical trials and regulatory submissions
• Demonstrated success managing CROs and external vendors in a late-stage development environment
• Proven track record as a strategic biometrics leader, contributing substantively to complex study designs, endpoint development, and statistical strategy across global development programs; able to provide sharp, on-your-feet thinking in real-time discussions with regulators, KOLs, and cross-functional teams, while maintaining a roll-up-your-sleeves approach to engage directly with protocols, analysis plans, and data when needed.
• Strong understanding of global regulatory expectations related to clinical data, statistical analyses, and inspection readiness
• Proven ability to operate strategically while remaining hands-on in a lean organization
• Strong written and verbal communication skills with a collaborative, team-oriented approach
• Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
• Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude

Preferred experience & skills:

• Prior experience serving as a functional or biometrics lead in regulatory interactions with FDA and ex-U.S. health authorities
• Experience in cardiovascular, rare disease, or genetically driven conditions
• Background in small or mid-sized biotech companies transitioning into late-stage development
• Experience building or scaling internal biometrics functions and infrastructure
• Familiarity with innovative trial designs and modern statistical methodologies

Base Salary Range: $300K - $375K

Company: 

At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and geographic atrophy, we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon, you’ll be part of a team committed to making an impact together.   

For more information on Annexon and our pipeline, check out our site Annexon Biosciences & Annexon Pipeline. We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane, CA. 

We're seeking exceptional talent from all backgrounds to fuel our growth. At Annexon, we're building a diverse, equitable, and inclusive workplace. We value unique perspectives and unconventional paths. If you're the best candidate for the job, even if you don't perfectly fit the traditional mold, we encourage you to apply. Learn more about our commitment to diversity, equity, inclusion, and our company culture! 

Position: 

The Clinical Trial Specialist (CTS) is primarily responsible for the coordination of activities associated with the setup and management of clinical studies under the direction of, or as delegated by a member of the Global Clinical Operations team. Responsibilities will range from clinical study coordination to data entry projects and general office work. This position will report to the Sr. Director of Clinical Operations.

Responsibilities include: 

• Help provide accurate and up-to-date study status information to the organization.
• Implement accurate tracking systems, forms, and other relevant documents to support clinical studies
• Assist the clinical operations team with vendor management, including tracking all study invoices and payments
• Assist in the preparation of spreadsheets, presentations, etc. utilizing Microsoft Office Suite
• Assist in the periodic review and QC of eTMFs to support inspection readiness and archiving of completed studies
• Maintain electronic files of clinical trial documents for ongoing projects
• Coordinate logistics for clinical operations team meetings, kick-off meetings, etc. Prepare draft minutes from the various meetings for review and finalization
• Assist in the tracking of clinical lab samples for multiple clinical trials, including tracking shipments of samples from lab vendors and helping maintain documentation of reconciliation practices and follow up any outstanding items

Education, Experience, and Skills: 

Required:

• Science or nursing degree, BA, BS, RN, or higher or equivalent combination of education and experience in Biotech or Pharmaceutical industry sectors
• 0 -2 years of experience as a Clinical Trial Assistant or Clinical Study Coordinator
• Knowledge of ICH GCPs is a plus
• Proficient with MS Word, Excel, and PowerPoint
• Strong interpersonal, communication (written and verbal)
• Excellent organizational skills
• Ability to work as part of a multi-functional study team
• Based in the San Francisco Bay Area

Salary Range: $93,500 - $97,700

Location: Annexon Biosciences is located in Brisbane, California and preference is given to candidates in the San Francisco Bay Area. 

Benefits: 

• A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
• Shuttle service from BART, CalTrain and the Ferry.
• Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, and other benefits. 

Annexon Biosciences is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind.  We are committed to fostering an environment where ALL people are welcome and supported. We cultivate a culture of inclusion for all employees that respects their individual strengths, views, and experiences. We believe that our differences enable us to be a better team – one that makes better decisions, drives innovation, and delivers better business results. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect. 

The role:

The Associate Director/Director, Clinical Supplies Management will lead Braveheart’s efforts to produce and distribute packaged drug product to clinical trial sites, and establish the procedures for label-pack and distribution activities for eventual commercialization of Braveheart products. Reporting into the SVP, Development Operations, you will be responsible for inter-site shipping logistics for drug substances and drug products, ancillary materials, intermediates and samples between external partners, including materials for non-clinical studies, clinical trials, and analytical testing. As a member of Braveheart’s CMC (Technical Operations) team, the successful candidate will interface with a diverse team representing Manufacturing and Quality; Program Management, Clinical Development, Clinical Operations, Finance and external partners to support key tasks related to planning, shipping & logistics, labeling, packaging and distribution of investigational materials.  

Key responsibilities:

• Ensure alignment of key activities & timelines of cross-functional team to successfully set up and supply each clinical trial, including maintaining oversight on performance and issues to ensure study supplies are provided in line with the agreed scope of work and timelines. 
• Establish shipping lanes and logistics processes for new clinical trials or new clinical sites including preparation of shipping, importation and exportation documents. 
• Coordinate the resolution of sample and product shipment delays and deviations with vendors, internal teams and partners. Proactively identify potential shipment delays and escalate as needed. Perform root cause analysis of shipping issues in order to identify process improvements. 
• Serve as the single point of contact for key stakeholders for logistics topics. 
• Provide a responsive, effective and successful high level of customer service to Clinical Operations, CMC and Nonclinical partners. 
• Participate in cross-functional distribution-related projects and process improvement initiatives. 
• Enhance delivery of Braveheart’s CMC objectives by fostering strong CDMO/CRO relationships.  
• Use appropriate project management tools to plan and track project deliverables. 
• Participate in CMC Team meetings and provide logistics and supply updates to the Vice President of Manufacturing and CMC and SVP of Development Operations.  
• Facilitate tracking of the movement of drug, intermediates and samples for analytical testing between external partners. 
• Analyze shipping temperature monitoring data and participate/lead investigations for excursions, in close collaboration with Quality. 
• Interface between CMC and Clinical Operations to ensure planning, coordination and communication to enable timely supply of materials. 
• Assist with CMC project budget planning and tracking, including invoice payments, accruals and reforecasting as needed. 
• Assist with circulating RFPs, establishing contracts, amending and approving work programs.  

Required experience & skills:

• Bachelor’s degree in a scientific discipline or business management 
• At least 7 years of experience in logistics and/or supply chain discipline in the Biotechnology/Pharmaceutical industry; supply chain certification is a plus (e.g. APICS, CPIM, CSCP) 
• Extensive experience in Global Import/Export logistics within the biotech/pharmaceutical industry
• Experience in the exportation and importation of human biologic samples and investigational drugs, specific experience in China preferred 
• Proven ability to collaborate effectively on cross-functional teams, both locally and globally, building strong relationships and leading with sophistication across cultures 
• Ability to influence without direct authority and communicate effectively with management, peers, customers, and vendors 
• Strong organizational skills with the ability to prioritize, manage competing priorities, and work independently with high accountability 
• Excellent problem-solving skills, with the ability to anticipate issues and recommend and implement solutions 
• Agile learner who can move effectively between detailed execution and broader project strategy 
• Experience with project integration, planning, documentation, and use of planning tools (Microsoft Project, Excel, PowerPoint and Outlook) 
• Ability to work flexible hours to support global requirements 
• Strong written and verbal communication skills with a collaborative, team-oriented approach 
• Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity 
• Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude 

Preferred experience & skills:

• Direct experience managing global clinical trial supplies 
• Experience managing projects with remote teams and through external alliances 

Salary Range: $174 - $233K

Who We Are:

Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.

Position Description:

We are seeking an experienced Associate Director, External Communications to join our Corporate Communications team. In this key role, you will develop and execute communication plans that increase awareness of Calico’s scientific advancements, clinical milestones, and partnerships. 

Reporting to the Senior Director of Corporate Communications, you will play a key role in maintaining a cohesive brand narrative that reinforces Calico’s overarching mission and translating scientific excellence into compelling external presence as we advance our lead programs toward potential commercialization and patient impact. In addition to subject matter expertise, this position will require strong collaboration and project management skills as you will work with a cross-functional team to shape how our development programs are perceived by the global scientific and medical communities, patients, advocacy groups, media, and our employees. 

Responsibilities: 

• Drive communication strategies that develop scientific and medical thought leadership, positioning Calico and its leaders as credible voices through publications, congress presence, executive visibility, and media engagement
• Develop compelling, consistent, and effective messaging for corporate communications materials such as press releases, media materials, Q&A, slide decks, talking points, website content, social media, and videos
• Partner with cross-functional team members to drive disease awareness and patient advocacy communications across our clinical programs, particularly our current lead indications 
• Effectively collaborate with cross-functional teams, external partners, and agencies to ensure high quality and compliant communications that drive clinical trial recruitment and brand awareness across our clinical portfolio
• Serve as a frontline responder for external/media inquiries and manage communications surrounding clinical data readouts, regulatory milestones, and patient/caregiver inquiries
• Work with partners to develop and execute deal communications
• Provide ad-hoc support across internal communications as needed
• Proactively seek out opportunities to maximize the impact of Corporate Communications

Position Requirements: 

• Bachelor’s degree in Communications, Journalism, or life sciences field is required, advanced degree a plus 
• 10+ years of experience in public relations or communications within the biotech or pharmaceutical industry, including product communications (rare disease experience a plus)
• Direct experience managing pre-launch communications for a breakthrough or orphan drug therapy is highly preferred
• Strong scientific understanding of a how a molecule moves through the discovery and development lifecycle 
• Exceptional verbal and written communication skills with a proven track record of translating complex science for diverse audiences
• Expert at managing multiple high-stakes projects simultaneously without compromising accuracy or quality
• Ability to bridge high-level strategic planning with meticulous tactical execution 
• Demonstrated agency and urgency in driving projects forward while remaining thoughtful and inclusive of cross-functional partners
• Confidence to influence and align senior stakeholders to support communication objectives
• Must be willing to work onsite at least four days a week

The estimated base salary range for this role is $195,000 - $200,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.

Position: Vendor & Budget Manager, Clinical Operations

Location: South San Francisco, CA

Opportunity:

Epicrispr Biotechnologies is seeking a Vendor and Budget Manager to join our growing Clinical Operations team. This role will play a critical part in overseeing vendor relationships, contracts, and budgets to support the successful execution of our clinical programs. This is a highly cross-functional role partnering closely with Clinical Operations, Finance, Legal, and external vendors to ensure studies are executed efficiently and in alignment with timelines, scope, and budget.

Roles and Responsibilities:

• Primary administrative point of contact for vendor coordination and communications, ensuring alignment with study priorities defined by Clinical Operations.
• Handle logistical setup of new vendors including coordinating contract reviews with internal stakeholders and legal and budget negotiation, in alignment with study scope and requirements defined by Clinical Operations.
• Manage all existing clinical vendors, requiring contract oversight and coordination with legal and internal teams, budget and PO oversight alongside internal finance and accounting, while partnering with the CTM and other Clinical Operations team members to ensure vendor deliverables align with study needs.
• Oversee site master budgets and ensure alignment with protocol updates, in coordination with CTM and Clin Ops priorities.
• Approve vendor invoices and budgets, including pass throughs from CRO, ensuring consistency with agreed scopes of work and escalation of discrepancies as needed.
• Support CMO, CTM, and Clinical Operations Lead with review of budget reporting from CRO alongside finance and accounting team.
• Track vendor performance, deliverables, contractual obligations, and escalate risks or delays to the Clinical Operations Lead.

Requirements:

• Bachelor’s degree in life sciences, business, or related field required
• Typically 5+ years of experience in clinical operations, vendor management, or clinical trial management within biotech, pharma, or CRO environments
• Strong understanding of clinical trial processes, vendor oversight, and GCP/ICH guidelines
• Experience managing contracts, budgets, and vendor relationships across multiple studies or programs
• Familiarity with CRO models, pass-through costs, and financial tracking processes
• Excellent organizational and project management skills with strong attention to detail
• Strong communication and stakeholder management skills, with the ability to work cross-functionally
• Ability to manage multiple priorities in a fast-paced, evolving environment
• Proficiency with clinical systems (e.g., CTMS, eTMF) and financial tracking tools preferred

Compensation: The salary range for this position is $135,000 to $145,000 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location. 

Position: Senior Clinical Research Associate

Location: South San Francisco, CA

Opportunity:
Epicrispr Bio is seeking a detail-oriented and proactive Senior Clinical Research Associate (CRA) to support the execution and oversight of clinical trials. This role will play a key part in ensuring studies are conducted in compliance with regulatory requirements, GCP guidelines, and company protocols, while maintaining the highest standards of quality and data integrity.

The ideal candidate will bring a strong foundation in clinical operations, experience working cross-functionally with CROs and clinical teams, and the ability to independently manage site activities while contributing to process improvements in a fast-paced, growing environment. This is an opportunity to have meaningful impact on clinical development programs while helping to build and scale operational excellence within the organization.

Roles and Responsibilities:

• Assist the Clinical Operations team with on-site sample operations, including sample receipt, registration, and shipments in a GCP environment.
• Support clinical trial manager with site management, including: site startup activities, co-monitoring visits alongside CRO, reviewing monitoring visit reports, coordinating vendor trainings, reviewing study newsletters, and other duties as needed, in alignment with study priorities and CTM guidance.
• Assist clinical trial manager with data verification and ICF reviews as needed, alongside CRO, to support data quality and protocol compliance.
• Partner with CTM and clinical team to help identify areas to improve our processes, with priorities defined by the CTM, and support implementation of agreed-upon improvements.
• Identify and communicate site-level issues, protocol deviations, and operational risks to the CTM to support timely resolution.
• Maintain study trackers, logs, and documentation across regulatory, site, data, and sample operations to support study oversight and execution.

Qualifications:

• Bachelor’s degree in life sciences or related field preferred
• 2 - 5+ years of CRA or clinical research experience (biotech, pharma, or CRO environment)
• Strong understanding of GCP, ICH guidelines, and clinical trial processes
• Experience working with CROs and managing clinical sites
• Excellent organizational, communication, and problem-solving skills
• Ability to manage multiple priorities in a fast-paced environment

Compensation: The salary range for this position is $115,000 to $121,000 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location. 

The role:

The Clinical Trial Management Associate (CTMA) is a key member of the Clinical Operations team and will partner closely with the Clinical Trial Manager (CTM), Senior CTM, and Associate Director, Clinical Operations. The CTMA will support the execution of a global Phase 3 program, with a primary focus on study coordination, documentation, and operational support. Under the supervision of the Associate Director, Clinical Operations or the Senior CTM, the CTMA may manage sites within a region (e.g., EMEA or Americas) and/or vendors (e.g., IRT, eCOA, etc.)

Key responsibilities:

• Provide operational and administrative support for day-to-day clinical trial activities, including study start-up, maintenance, and close-out.
• Support site start-up activities, including tracking of site start-up components and assisting with site activation readiness.
• Accountable for study level tracking at Sponsor (e.g., monitoring visit tracking, sample tracking, patient tracking, site activation tracking, etc.)
• Act as a point of contact for CROs and study sites for routine communications and follow-ups, including escalations and engagement. Assist with coordination of investigator meetings and study-related communications.
• Track study timelines, deliverables, and key milestones; proactively follow up on outstanding items.
• Maintain internal Clinical Operations systems, trackers, and document repositories. Prepare and distribute study status updates and meeting minutes and ensure vendors do the same.
• Assist with vendor coordination and oversight, including vendor set-up, performance, and deliverable tracking. May assist with administration of invoice reconciliation, scoping, and change orders, for clinical trial operations.
• Support review of study documents (e.g., informed consent forms, regulatory packages) and route for approval.
• Maintain and QC the Trial Master File (TMF) and ensure documents are filed in a timely and compliant manner; create, maintain, and close out TMFs; play a central role in setup, conduct, and close out of ancillary services; facilitate quality reviews and support trending activities.
• Facilitate and/or assist in review of CRO monitoring trip reports for completeness and consistency and, under supervision of other Operations personnel, may complete co-monitoring activities.
• Track protocol deviations and support trending activities.
• Support data review activities, including tracking queries and assisting with data listings review.
• Perform administrative duties in a timely manner as assigned.
• Adhere to Clinical Operations processes and SOPs.

Required experience & skills:

• BS or BA in a relevant scientific discipline or RN (2- or 3-year certificate)
• Minimum of 2 years of relevant clinical trial experience
• Clinical trial experience in the pharmaceutical or biotechnology industry 
• Excellent attention-to-detail, interpersonal and presentation skills are a critical asset
• Excellent organizational, problem-solving and time management skills
• Must be familiar with routine medical/scientific terminology
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable
• Must be familiar with Word, PowerPoint, and Excel (intermediate or higher excel proficiency a plus)
• Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision
• High energy level, personal productivity, creativity and commitment
• Highly adaptable team-player; eager to learn
• Strong written and verbal communication skills with a collaborative, team-oriented approach
• Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
• Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude
• This position is for remote work and may require domestic or international travel up to 25% (as needed); valid travel documents must be obtainable

Salary Range: $100,000 - $135,000

The role:

The Senior Clinical Trial Manager (Sr. CTM) is a key leader within the Clinical Operations team and will report to the Senior Director, Clinical Operations. The Sr. CTM will be responsible for the end-to-end operational delivery of a study in collaboration with other study leads across the program. This includes providing strategic oversight of study execution, vendor management, financial accountability, and cross-functional alignment.

Key responsibilities:

• Serve as the study lead for one or more global clinical trials, overseeing day-to-day execution from start-up through close-out (including site activation, enrollment, study conduct, and close-out) under the guidance of the Senior Director, Clinical Operations.
• Partner closely with the Clinical Operations study leads on key decisions by providing recommendations, proactively identifying risks, and escalating critical issues with proposed mitigation strategies.
• Drive study timelines, deliverables, and operational plans, ensuring alignment with overall program strategy. Monitor study metrics, including data quality, protocol deviations, and site performance, and drive appropriate follow-up actions.
• Oversee and support regional study execution, including site selection strategy, site start-up, and study progress; ensure efficient and timely study start-up across regions. Oversee and participate in the review of informed consent forms and regulatory submission packages.
• Perform visits (PSSVs, SIVs, RMVs) as required to demonstrate appropriate oversight of CRO CRAs and study sites to ensure study procedure conduct is in accordance with the study protocol, SOPs, regulatory requirements, and study plans.
• Oversee CRO and vendor activities, ensuring performance aligns with study expectations, timelines, budget, and quality standards. Support budget tracking and vendor financial oversight.
• Support cross-functional coordination across Clinical, Regulatory, Data Management, Safety, and other stakeholders to ensure aligned study execution.
• Contribute to, or own the development of, key study documents (e.g., protocols, ICFs, CRFs, monitoring plans, CSRs); under the guidance of the Senior Director, Clinical Operations (or designee) develop operational documents such as vendor specifications, study plans, SIV materials, Investigator Meeting content, and protocol amendments.
• Ensure inspection readiness and compliance with GCP, SOPs, and regulatory requirements, including timely TMF filing.
• Participate in study reviews, including data listings, protocol deviation review, TMF quality, and monitoring visit reports; identify trends and drive appropriate follow-up actions.
• Provide regular, structured study updates to internal stakeholders as directed by the Senior Director, Clinical Operations.
• Mentor and provide day-to-day guidance to CTMs, CTMAs, and other junior team members that may be providing study support or regional management.
• Perform administrative duties in a timely manner as assigned.
• Contribute to Clinical Operations process improvements and departmental initiatives, as requested by the Senior Director, Clinical Operations.

Required experience & skills:

• BS or BA in a scientific discipline or an RN (2- or 3-year certificate)
• At least 6 years of clinical trials/operations experience in the pharmaceutical or biotechnology industry
• Proven ability to manage complex, cross-functional projects and timelines
• Experience as a regional lead (e.g., Europe, Americas, and/or APAC) on a Phase 3 (or large Phase 2) study required; study lead experience preferred
• Strong experience with CRO and vendor management, including oversight of performance and deliverables
• Excellent leadership, communication, and stakeholder management skills
• Strong organizational and time management skills
• Strong problem-solving skills, with the ability to anticipate risks and implement mitigation strategies
• Excellent attention-to-detail, interpersonal and presentation skills are a critical asset; high energy level, personal productivity, creativity and commitment
• Proven track record of mentoring and developing junior team members through coaching and knowledge-sharing; direct people management experience is a plus
• Strong written and verbal communication skills with a collaborative, team-oriented approach.
• Must be familiar with routine medical/scientific terminology
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
• Must be familiar with Word, PowerPoint, and Excel (intermediate or higher excel proficiency is a plus)
• Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision
• Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
• Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude
• This position is for remote work and may require domestic or international travel up to 25% (as needed); valid travel documents must be obtainable

Salary Range: $160K to $185K

Who We Are:

Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.

Position Description:

The Medical Director/Senior Medical Director at Calico will report to the Head of Clinical Sciences and will be responsible for providing strategic input to the translational and clinical development of projects related to Calico’s mission to improve human health span by understanding aging and age-related diseases. This position is focused on neurologic/neuropsychiatric indications.

Position Responsibilities:

• Leads cross-functional teams which develop the strategy to translate preclinical mechanistic data to humans and to develop translational biomarkers for novel targets in neurological/neuropsychiatric indications
• Actively interfaces with research and drug development leaders, at Calico and outside of Calico, to inform disease indication strategies for novel targets
• Utilizes clinical expertise to guide the development and utilization of preclinical models in close collaboration with discovery and biomarker scientists at Calico and Calico’s business partners
• Works closely with other drug developmental functional areas to shape new clinical programs at multiple points in their evolution, with an emphasis on translational/early clinical development (Phase 0 through Phase 2)
• Designs and executes experimental medicine studies to demonstrate proof-of-mechanism of novel targets in neuropsychiatric diseases
• Designs and executes early clinical development plans to demonstrate proof-of-concept in various neuropsychiatric indications
• Provides scientific/medical content and other input as appropriate for protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents

Position Requirements:

• Scientifically minded Physician (M.D.) or Physician-Scientist (M.D./Ph.D.)
• At least 5 years of translational, clinical trial, or drug development experience in the biotech/pharmaceutical industry, academia, or equivalent
• Board-certified/eligible in Neurology and/or Pediatric Neurology highly preferred
• Clinical/translational research and/or drug development experience across various neuropsychiatric disease areas
• Medical knowledge in treating patients across various neuropsychiatric or neurological indications
• Working knowledge or direct experience in early clinical trial methodology (Phase 0, Phase 1, Phase 2)
• Proven leadership skills and ability to bring out the best in others on a cross-functional team
• Able to provide effective leadership through influence in a highly matrixed environment, including various drug development functions within Calico and its development partners
• Must possess excellent oral and written English communication skills
• Must be willing to work onsite at least 4 days a week

The estimated base salary range for this role is $374,000 - $435,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.

Who We Are:

Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.

Position Description:

The Associate Director, Clinical Scientist at Calico is responsible for the planning and execution of the translational and clinical development plans and protocols for several projects across therapeutic areas, related to Calico’s mission to improve human healthspan by understanding aging and age-related diseases. The successful candidate will participate in and drive the development of clinical strategies for assigned program(s)/indication(s) and should be able to support novel and innovative clinical plans while ensuring a positive and collaborative team environment.

Responsibilities:

• In coordination with the Head of Clinical Science and/or Medical Director(s), leads or represents the Clinical Science function in cross-functional project and study teams that develop and execute the clinical development plan to translate preclinical mechanistic data to humans for novel aging-related targets
• Authors clinical sections of assigned protocols from Phase 0 through Phase 2, collaborating with other functions required for protocol development, including Research, Biomarkers, Clinical Operations, Regulatory Affairs, Clinical Pharmacology, Biometrics, Pharmacovigilance, Toxicology, and Medical Writing
• Contributes to the design and execution of experimental medicine studies to demonstrate proof-of-mechanism of novel targets in aging and age-related diseases
• Interfaces with academic investigators to assist in execution of Investigator initiated trials
• Contributes to and/or reviews relevant study documents including Investigational Brochures, Clinical Study Reports, Statistical Analysis Plans, Operations/Technical Manuals, IND/CTAs, case report forms and data tables, listings and figures, CSRs
• Trains CROs and study site personnel on assigned protocols and addresses protocol queries as they arise
• Participates in the assessment of CROs and study vendors

Position Requirements:

•  BS/MS in a relevant scientific discipline with 8+ years or PhD/PharmD with 5+ years of experience in early clinical drug development in the biotech/pharmaceutical industry performing the responsibilities described above
• Experience in early clinical trial methodology (Phase 0, Phase 1, Phase 2) and knowledge of drug development process and clinical deliverables from IND through clinical proof-of-concept
• Excellent understanding of clinically relevant ICH GCP guidance, FDA and EMA regulations
• Ability to perform role responsibilities largely independently
• Proven leadership skills and ability to bring out the best in others on a cross-functional team
• Able to provide effective leadership through influence across organizations on partnered programs
• Detail-oriented mindset with excellent oral and written English communication skills 
• Must be willing to work onsite at least 4 days a week

The estimated base salary range for this role is $238,000 - $245,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.

About the Role >>> Associate Director, GCP Quality Assurance   

As the Associate Director, GCP Quality Assurance, reporting to the Senior Director GCP Quality Assurance, you will be partnering with Clinical Development/Operations, Pharmacovigilance and Safety in cross-functional study teams to drive GCP/GVP compliance. This will include identifying and communicating clinical trial-related risks and opportunities for process improvement, as well as reviewing / approving study-related documents and plans and supporting audits.  

This hybrid role is based out of either our San Francisco, CA or Cambridge, MA office and requires up to 20% travel. 

Your work will primarily encompass: 

• Performs internal and external audits as assigned to ensure compliance with GCP/GVP regulations and guidelines 
• Provide GCP/GVP auditing activities, including audit preparation, execution, report preparation, and follow-up to any findings/observations, including corrective and preventive actions (CAPAs), communicate audit results to internal stakeholders  
• Partner with QA leadership during regulatory authority inspections and drive  GxP inspection readiness activities 
• Oversees quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP/GVP 
• Prepare for health authority inspections, suppliers and or clinical sites 
• Oversee clinical compliance and quality within the context of cross-functional study teams 
• Continue to improve/refine Olema’s risk-based GCP compliance approach globally 
• Manage Quality Management System (QMS) including, but not be limited to, the following activities: QA review/approval of deviations, CAPAs and change controls 
• Draft, review, and approve policies, procedures, and work instructions 

Ideal Candidate Profile >>> Key Requirements 

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor’s Degree or higher in a scientific discipline 
• Strong understanding of clinical trials and pharmacovigilance reporting  
• In-depth knowledge of and ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines 
• Understanding of industry quality management tools, quality systems (e.g., QMS, eTMF, EMRs, EDC, etc.) 

Experience: 

• A minimum of 8 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment 
• Demonstrated experience leading and/or conducting internal and external QA audits developing and executing risk-based audit plans 
• Demonstrated ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors 
• Hands-on experience with regulatory inspections and inspection readiness activities 
• Experience writing and reviewing SOPs 
• Experience using QMS (Veeva systems preferred) 
• Knowledge and experience in Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) regulations. In addition, preferred Good Laboratory Practice (GLP) experience 
• Ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines 

Attributes: 

• Excellent verbal and written communication skills 
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members 
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines 
• Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects 
• Ability to work hands-on and be a strong individual contributor 

The base pay range for this position is expected to be $190,000 - $205,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-CK1

What You'll Do

The Associate Medical Director, Endocrinology - is a medical and scientific leadership role within United States Medical Affairs that supports development and execution of the Medical Affairs strategy for encaleret across clinical development programs, including autosomal dominant hypocalcemia type 1 (ADH1) and chronic hypoparathyroidism, with focus on launch readiness and lifecycle planning grounded in scientific rigor and patient focused decision making.

This position partners across Clinical Development, Scientific Communications, Congress Operations, Regulatory, Commercial, Patient Advocacy, and Field Medical to support trial execution, data disclosure and publication planning, peer to peer scientific exchange, and coordinated congress strategy and materials. The Associate Medical Director also supports strategic external relationships with investigators, key opinion leaders, and other stakeholders and co-leads advisory boards and expert panels to inform Medical Affairs programs and priorities.

Responsibilities

• Support development and execution of the United States Medical Affairs strategy for encaleret in ADH1 and chronic hypoparathyroidism, including launch readiness and lifecycle planning with scientific rigor and patient focused decision making
• Support integrated evidence generation planning and execution, including real world evidence, Phase 4 studies, registries, investigator-initiated research support, and data integration activities
• Support omnichannel HCP engagement by enabling field and digital scientific exchange, gathering insights, and translating themes into Medical Affairs programs and tactics
• Support strategic relationships with key opinion leaders, investigators, and external stakeholders across endocrinology, nephrology, and related specialties, and co-lead advisory boards and expert panels
• Partner with Clinical Development to support ongoing and planned clinical trials and contribute to data disclosure and publication planning with Scientific Communications
• Support peer to peer scientific exchange and external education programs, including congress and clinical meeting preparation and scientific materials development
• Partner with Congress Operations and Scientific Communications to define congress strategy, align scientific narratives and data priorities, and deliver coordinated pre congress, onsite, and post congress medical plans
• Ability to travel up to ~40% for scientific meetings, advisory boards, and internal engagements

Where You'll Work

This is a hybrid role and requires in-office collaboration 3x per week in our San Francisco and Palo Alto Offices.

Who You Are

• MD, DO, PharmD, PhD, or equivalent advanced scientific or clinical degree
• 4+ years of experience in Medical Affairs, Clinical Development, or related roles within the biopharmaceutical industry and/or academic medicine
• Field Medical Affairs experience and field insight generation, is a plus
• Demonstrated experience supporting late-stage development, launch preparation, and post-marketing medical activities
• Strong scientific and clinical acumen with the ability to translate complex data into clear medical insights
• Proven leadership and influence in cross-functional, matrixed environments
• Excellent written and verbal communication skills
• Strong understanding of regulatory and compliance requirements impacting Medical Affairs and field activities
• Ability to work independently in a fast-paced, evolving organization
• Strategic mindset with hands-on execution capability

#LI-SS1

We are seeking an experienced and highly motivated Senior Scientist for the Drug Product Development group who can work in a collaborative and dynamic environment. The scientist in this role is responsible for activities critical to the development of Alumis’ molecules including generation of pre-formulation packages, formulation selection, and manufacturing process development. This primary focus of this role will currently be on solid oral dosage form development but may involve the development of other dosage forms in the future.

Responsibilities

• Hands-on pre-clinical formulation development includes identifying vehicles, excipients, and/or new technologies for poorly water-soluble compounds in support of preclinical PKPD, efficacy, and tox studies.
• Execute and/or oversee pre-formulation activities including characterization of physicochemical and solid-state properties for investigational small molecules with hands-on instrumental analysis (HPLC/UPLC, DSC, XRPD) and method development.
• Work effectively with external CDMOs to develop early-stage drug products and oversee production of clinical trial material in support of clinical timelines.
• Experience in formulation development, process optimization for small molecule solid oral dosage forms including modified-release products includes execute/oversee formulation and manufacturing process development activities.
• Excellent oral and writing communication skills and flexibility to work in a fast-paced team environment by providing updates (oral and written) clearly and concisely.
• Support relevant CMC sections for key regulatory filings including INDs and NDAs. Experience in authoring technical reports and regulatory documents (e.g. IND/NDA) is a plus.
• Comfortable in a fast-paced small company environment. Proactively identify project risks and prepare mitigation and contingency plans.
• Willing to travel as needed to support ongoing development activities.

Education 

Ph.D. degree in Pharmaceutical Sciences, Chemistry, Engineering or related field with a minimum of 8 years or B.S. or M.S. with a minimum of 10+ years related industrial experience.

Alumis Values

• Elevate
• Challenge
• Nurture

This position is located in South San Francisco, CA with three (3) to five (5) days a week in lab.  We are not considering remote applicants.  

The salary range for this position is $139,000 USD to $169,000 US annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.   

Alumis Inc. is an equal opportunity employer.

About the Position

Formation Bio is seeking a highly skilled and experienced Senior Director, Biostatistics to join our dynamic team. This critical role will report to the Head of Biometrics and will be responsible for leading and developing the biostatistics team and strategy, driving impactful statistical initiatives, and leveraging biostatistics to advance our drug development processes.

The Senior Director, Biostatistics will play a key role in shaping innovative trial designs, supporting regulatory strategies, and ensuring high-quality statistical contributions across clinical development. They will also collaborate cross-functionally to integrate advanced analytics, data-driven decision-making, and AI applications into our development programs to improve efficiency and increase the probability of success.

Responsibilities

• Strategic Leadership: Lead and develop the Biostatistics team, fostering a high-performance culture aligned with Formation Bio’s mission and values. Provide mentorship and career development to ensure team growth and expertise.
• Statistical Strategy & Innovation: Drive statistical strategy across clinical development programs, incorporating optimal trial designs, simulation-based approaches, and AI/ML applications to enhance efficiency and decision-making. Guide clinical and regulatory strategies to optimize trial design and maximize the probability of success.
• Study Design & Execution: Provide expert statistical input into clinical study design, endpoint selection, analysis planning, and regulatory interactions. Explore innovative trial design options to identify the most effective clinical development strategy that aligns with business needs and optimizes decision-making. Ensure study designs are scientifically rigorous, operationally feasible, and aligned with regulatory expectations. Leverage AI-driven clinical trial automation to enhance study execution, optimize resource allocation, and improve trial efficiency.
• Regulatory & Cross-Functional Collaboration: Partner with Clinical, Data Science, Regulatory, and Business Development teams to support drug diligence, development and regulatory interactions, FDA briefing books, and submission-related activities. Represent Biostatistics in key regulatory meetings (e.g., FDA, EMA) to ensure statistical rigor in clinical development plans.
• Operational Excellence: Establish and refine statistical workflows, SOPs, and best practices to improve efficiency, quality control, and compliance with industry standards.
• Data-Driven Decision-Making: Champion data-driven approaches and quantitative decision-making frameworks, integrating scenario analyses and statistical trial simulations to optimize clinical trial execution and strategic development plans.
• External Engagement: Stay at the forefront of industry trends and regulatory expectations, representing Formation Bio in scientific discussions, conferences, and collaborations.
• Vendor & CRO Management: Oversee and manage statistical vendors, including consulting statisticians and CROs, ensuring high-quality statistical deliverables and compliance with GCP and regulatory standards.

About You

• Ph.D. in Biostatistics, Statistics, or a related field with 10+ years of experience in biostatistics within the pharmaceutical or biotech industry, statistical consulting firms, or CROs supporting clinical development.
• Proven experience leading biostatistics teams and strategies within clinical development.
• Deep expertise in statistical trial designs, adaptive designs, Bayesian methods, and simulation-based approaches for both early and late-stage development.
• Strong understanding of regulatory guidelines for drug development, including FDA and EMA requirements for statistical practice, regulatory submissions, and health authority interactions.
• Experience in quantitative decision-making frameworks to support internal Go/No-Go decisions. 
• Demonstrated track record of leading statistical contributions to progress assets from diligence, early development through regulatory submissions and approvals.
• Ability to collaborate cross-functionally with Clinical, Data Management, Programming, Data Science, Regulatory, and other teams.
• Strong problem-solving skills with the ability to balance scientific rigor with operational efficiency.
• Excellent communication skills, with the ability to convey complex statistical concepts into actionable insights for non-statisticians, senior management, and regulatory agencies.
• Proficiency in SAS, R (S-Plus), and statistical software for sample size calculations (e.g., East, PASS, NQuery). Expert R programming skills are a plus.
• Passion for innovation, AI-driven methodologies, and data-driven decision-making in clinical development.

Total Compensation Range: $311,000 - $385,000

About the Position

We're looking for a Senior Data Engineer to join the Scientific Data Intelligence (SDI) team at Formation Bio to help transform Real World Data (RWD)—spanning electronic health records, claims, and other longitudinal patient data sources—into structured, analytics-ready assets. In this role, you'll be partnering closely with our Data Science team not only to model and transform data, but also to actively analyze it: answering research questions, generating evidence, and supporting scientific decision-making across our drug portfolio.

This position sits at the intersection of healthcare data engineering, real-world evidence analysis, and generative AI. While a strong foundation in building reliable, scalable pipelines is essential, you'll be equally expected to roll up your sleeves and work directly with the data—constructing cohorts, running analyses, and translating findings into actionable insights for scientific and business stakeholders.

The ideal candidate is a hybrid of data engineer and applied scientist: someone who can build the infrastructure and then use it, with familiarity in RWD study design, GenAI fluency (e.g., LLM-based entity extraction, summarization, classification), and strong technical expertise with modern data tooling. You'll play a key role in shaping how real-world patient data becomes discoverable, structured, and impactful across the organization.

Responsibilities

• Model and transform raw EHR and claims data into clean, canonical, and analytics-ready datasets using SQL, Python, and clinical standards like OMOP.
• Build and manage scalable data pipelines using Dagster for orchestration, dbt for transformation, and Snowflake as the primary compute and storage engine.
• Conduct hands-on RWD analyses to answer scientific and strategic research questions—including disease epidemiology, treatment patterns, patient journey characterization, and comparative effectiveness.
• Partner with Data Scientists and clinical leads to design and execute observational studies, translating scientific questions into well-structured, reproducible analyses.
• Implement data validation, completeness, and observability frameworks to ensure real-world datasets are accurate, comprehensive, and trustworthy for downstream research and product use.
• Apply Generative AI techniques within transformation and analysis layers to accelerate data structuring and insight generation.
• Communicate findings clearly to both technical and non-technical stakeholders, including summaries for portfolio teams and leadership.

About You

• You have 5+ years of experience in data engineering, ideally with at least 2 years working in healthcare or life sciences, including direct exposure to EHR or claims datasets.
• You have experience with ontologies and biomedical schemas (e.g. UMLS, LOINC, ICD9/10, MeSH) and understand the modalities found within RWD — billing claims, lab results, visit notes.
• You're fluent in SQL and Python, and you've built and maintained production-grade pipelines that support analytics or scientific workflows.
• You have experience building longitudinal patient cohorts from EHR or claims data, including index date logic, washout periods, and follow-up window construction.
• You have a solid understanding of the causal inference frameworks such as potential outcomes and target trial emulation. 
• You have working familiarity with real-world evidence study design concepts—such as active comparator new user designs, time-to-event outcomes, confounder adjustment, and causal discovery algorithms—sufficient to partner effectively with Data Scientists on causal inference workflows.
• You value clarity, documentation, and structured thinking—especially when working with complex healthcare data.
• You have hands-on expertise with modern data infrastructure, such as Snowflake, dbt, and Dagster.
• You can balance upfront design with speed to execution, slowing down when it counts without getting stuck in the details.
• Bonus: You've worked in regulated or privacy-sensitive data environments and are familiar with governance models for PHI or sensitive data.
• Bonus: You have prior experience working with commercial RWD vendors (e.g. Truveta, Optum, Komodo, IQVIA) and understand the nuances of licensed claims and EHR datasets, including longitudinal patient journey construction and line-of-therapy sequencing.

Total Compensation Range: $204,500 - $267,000

Please note that this position can be based in San Diego, CA OR San Francisco, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Associate Director, Trial Master File (TMF) Oversight & Inspection Readiness (IR) is responsible for leading the operational oversight of the TMF and supporting the framework that ensures Trial Master File integrity, sustained inspection readiness, and regulatory compliance within Clinical Operations.  This role leads TMF health governance, inspection preparedness, and risk identification processes to safeguard the organization during regulatory inspections and audits.  The Associate Director serves as the Clinical Operations lead for inspection defense, by advancing consistent standards, proactive risk visibility, and clear organizational insight into TMF integrity and inspection readiness.

Primary Responsibilities

TMF Oversight & Governance

• Establish TMF health oversight framework across studies, ensuring compliance with GCP and industry standards.

• Monitor TMF quality metrics across programs, ensuring completeness, timeliness, and accuracy of essential documents; Escalate any TMF metrics falling outside of KPIs to appropriate stakeholders for resolution and corrective action.

• Lead and share TMF best practices with internal and external stakeholders, as appropriate. Oversee TMF risk trending and remediation plans.

• Maintain inspection-readiness standards for documentation.

Inspection Readiness Leadership

• Develop and maintain a sustainable inspection readiness model, including development and maintenance of comprehensive inspection readiness tools, reference materials and coordinating training guidance to staff on preparation efforts for health authority inspections.

• Lead inspection storyboarding and narrative development. Coordinate inspection preparation activities. Lead designated Clinical Operations activities during regulatory inspections.

• Support post-inspection CAPA alignment, in partnership with Quality.

• Support Clinical Operations team on all inspection commitments, responses, post-inspection activities and implementation of corrective and preventative actions; provide lessons learned from mock and actual inspections. Ensure portfolio-level visibility of inspection risk.

Other Responsibilities

• Partner cross-functionally to align on audit and inspection strategy, as well as TMF platform integrity. Align with functional study teams on TMF accountability expectations. Maintain awareness of industry trends and developments to help define the future strategic direction for TMF and Inspection Readiness.

• Other responsibilities as required.

Education/Experience/Skills

Bachelor’s degree in life sciences or related field; Advanced degree preferred.  Targeting at least 8 years pharmaceutical industry and/or clinical research organization experience, with at least 5 years TMF experience in a leadership role.  Health Authority inspection and eTMF experience is required. An equivalent combination of relevant education and experience may be considered.

Key Skills

• Thorough understanding of GCP and ICH guidelines; thorough understanding of the drug development process.

• Knowledge and understanding of the current regulatory requirements (e.g., FDA, EMA, MHRA) in a global environment.

• Thorough understanding of the CDISC TMF Reference model; direct experience with the TMF Reference Model working group is preferred.

• Veeva Vault eTMF/CTMS experience preferred.

• Ability to lead, motivate, and influence others, including prior leadership experience, is strongly preferred.

• Adept at creating and communicating a clear vision among, effectively aligning resources and motivating stakeholders to achieve goals.

• Demonstrated analytical abilities and proficient planning and negotiation skills. Demonstrated technical, administrative and project management capabilities. 

• Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills.

• Demonstrated success with cross-functional collaboration and managing multiple assignments with timely and accurate output. Demonstrated problem-solving abilities, with strong attention to detail. 

• Able and willing to travel both domestically and internationally.

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds.  Ability to travel independently overnight and work after hours if required by travel schedule or business needs.

#LI-Hybrid #LI-SL1

What You'll Do

Manage lot release activities at the company’s Contract Manufacturing  Organizations (CMOs). The individual will act as QA Operations lead with assigned CMOs, including  review of manufacturing batch records, certificates of analysis and the issuance of certificates of compliance. The Sr. Manager, QA Operations - Product Release will ensure that the CMO SOPs and Master Batch Records are in compliance with cGMPs and will serve as the technical quality reviewer for deviations, change records, protocols, and CAPAs generated from or pertaining to Calcilytix or other BridgeBio affiliates, as needed. 

Responsibilities

• Represent QA Operations on internal and external project teams, audits and inspections, and participate in monitoring of CMO performance
• Review and manage master and executed manufacturing batch records from CMOs, including release activities, and  related documents such as specifications, analytical and microbiological methods, stability study/protocols, process and method validation protocols and reports
• Author and perform quality review of SOPs and quality events (deviations/investigations, OOSs/OOTs, change controls, supplier notifications, etc.)
• Lead disposition of Drug Substance (DS), Drug Product (DP) and Finished Product (FP)
• Communicate/escalate manufacturing deficiencies/non-conformances to management, present issues during escalation, and work with CMOs to ensure timely resolution
• Support review of regulatory filings
• Support audit of CMOs

Where You'll Work

This is a hybrid role and requires in-office collaboration 2-3x per week in our San Francisco Office or a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.

Who You Are

• Bachelor's Degree in a science discipline with 8+ years of experience within a biopharmaceutical company, or contract research organization
• Strong knowledge of GMP, SOPs, Quality Systems (e.g. Lot Release, Deviation, Change Control, CAPA), ICH and GxP principles
• General knowledge of FDA and other global clinical trial regulations
• Prior experience in QC, Analytical Development and process validation highly desired
• Excellent verbal and written communication skills, with a strong customer focus
• Excellent organizational skills, ability to manage multiple tasks and competing priorities, and maintain meticulous attention to detail
• Travel up to 10% total time
• You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial Benefits:

• Market leading compensation 
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work 
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability 
• Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

#LI-SG1

What You'll Do

The Associate Director of Biomarker Science will be leading assay development, validation, and translational biomarker strategies across BridgeBio affiliate programs. This role requires a hands-on scientific leader who can design and validate assays, integrate biomarkers into clinical development, manage vendor partnerships, and communicate results to internal and external stakeholders. The successful candidate will operate at the intersection of discovery, preclinical development and clinical operations- providing scientific leadership and operational rigor to accelerate program decision-making. This position includes supervisory responsibilities: you will both lead scientific work and manage a team of scientists and technical staff, providing coaching, career development, resource planning and performance management.

Responsibilities

Discovery & Biology Strategy

• Define the biology strategy to support target validation, mechanism-of-action studies, and medicinal chemistry optimization
• Design and execute in vitro and in vivo experiments that demonstrate target engagement, functional pharmacology and disease-relevant biology to inform med chem SAR and lead optimization
• Coordinate with medicinal chemistry, structural biology and pharmacology teams to prioritize compounds, define target product profiles, and support lead selection
• Translate discovery findings into criteria and experimental plans that feed into IND-enabling studies and inform go/no-go decision points

Assay Development and Validation:

• Lead design, development and validation of biomarker and pharmacodynamic assays (cell-based, biochemical, ELISA/multiplex immunoassays, Western blotting, biophysical protein characterization, etc.) to support translational and clinical programs
• Set assay performance criteria and qualification/validation plans; author SOPs and validation reports; implement QA/QC practices to ensure reproducible assay performance

Clinical Trial Support:

• Translate preclinical biomarker findings into clinical biomarker strategies and practical assay deployment plans
• Collaborate with clinical operations, sample management and biostatistics to design sample collection, processing, storage and chain-of-custody procedures
•  Oversee incorporation of biomarker testing into Phase 1–3 protocols, including sample handling, endpoint definitions and analysis plans

Vendor Management:

• Identify, qualify and manage relationships with external vendors, CROs and CLIA laboratories for assay development, transfer and routine execution
• Lead vendor qualification, technology transfer, assay bridging and vendor audits to ensure regulatory readiness and data quality

Regulatory Compliance and Filings:

• Ensure biomarker assays and data collection comply with applicable regulatory standards (GCP/GLP where applicable)
• Contribute clinical assay sections and assay validation summaries for regulatory submissions (INDs, briefing packages, NDAs) and support responses to regulatory questions

Data Management and Analysis:

• Partner with biostatistics to develop statistical analysis plans, define analytical endpoints and produce tables, listings and figures for decision-making and regulatory documents
• Oversee rigorous data capture, QC and reporting for clinical biomarker datasets and preclinical/clinical study reports
• Contribute to statistical analysis plans and the design of tables, listings, and figures

Scientific Communication & Leadership

• Prepare and present scientific reports, publications and conference abstracts; engage with key opinion leaders to inform biomarker strategy
• Present translational data to program teams and senior leadership; mentor and develop early-career scientists
• Support internal initiatives to capture lessons learned, propagate best practices and continuously improve biomarker workflows
• Collaborate with drug discovery, clinical development, and regulatory affairs teams to integrate biomarker strategies
• Present data to the broader MLBio team, including scientific, clinical, and business leaders

Where You'll Work

This role involves primarily hands-on laboratory responsibilities in our San Carlos, CA location.

Who You Are

• Minimum Education requirement:
• M.S. or Ph.D. in Biology, Biochemistry, Molecular Biology or a related discipline.

Relevant Experience

• Minimum 10 years of industry experience in translational science, biomarker development, or related roles supporting clinical development.
• Demonstrated track record developing and validating cell-based and biochemical assays for clinical use; experience with ELISA, multiplex immunoassays, Western blotting and protein characterization methods.
• Hands-on experience with assay transfer to CRO labs, vendor qualification, and supporting regulatory filings.
• Strong understanding of clinical study design, GCP, and regulatory expectations for biomarker data.
• Experience writing scientific and regulatory documents and collaborating with cross-functional teams including biostatistics.

Skills & Attributes

• Strong scientific judgment and experimental design skills; ability to interpret complex datasets and provide clear, actionable recommendations.
• Excellent written and oral communication; experience presenting to scientific and business audiences.
• Proven leadership and mentorship skills; collaborative, proactive and team-oriented approach.
• Detail-oriented with strong project management abilities and a commitment to high quality data and documentation.

Travel

• Travel for vendor management/audits and scientific meetings as required.

Company: 

At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and geographic atrophy, we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon, you’ll be part of a team committed to making an impact together.   

For more information on Annexon and our pipeline, check out our site Annexon Biosciences & Annexon Pipeline. We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane, CA. 

We're seeking exceptional talent from all backgrounds to fuel our growth. At Annexon, we're building a diverse, equitable, and inclusive workplace. We value unique perspectives and unconventional paths. If you're the best candidate for the job, even if you don't perfectly fit the traditional mold, we encourage you to apply. Learn more about our commitment to diversity, equity, inclusion, and our company culture! 

Position: 

The Field Medical Directors (FMDs) are medical experts who are an extension of the Medical Affairs team and represent Annexon with key stakeholders. They engage with national, regional, and local scientific, clinical, and social thought leaders (TLs) at academic and community medical centers as the scientific and medical expert on Annexon’s products and areas of research. This role will develop and maintain professional relationships with TLs based on scientific exchange of disease and Annexon product data. 

Responsibilities include: 

• Develop and maintain professional relationships with Thought Leaders (TLs) through compliant scientific exchange via two-way communication inclusive but not limited to pathogenesis of Therapeutic Areas (TA) of interest to Annexon, diagnosis, disease burden, treatment landscape, health economics, and relevant Annexon product data in line with medical affairs and Annexon strategy
• Collaborate with TLs on research projects, national and regional advisory boards, visiting professorships, publications, and peer-to-peer educational initiatives
• Develop and maintain the highest scientific and medical expertise in ophthalmologic disease, trials and treatment landscape with a patient centric mindset
• Identify potential high-impact medical research projects, investigator-initiated research, health-economic trials, and publication opportunities in line with Annexon TAs of interest
• Be acknowledged internally and externally as a trusted Scientific expert and build lasting professional relationships with TLs and Centers of Excellence & Research (COERs)
• Attend local, regional, national, international meetings and congresses as needed to engage in Scientific exchange, capture scientific insights, share data on Annexon products and TAs, and identify areas for collaboration with TLs
• Respond to healthcare professionals (HCPs) with integrity, a sense of urgency, adherence to all laws, regulations, and Annexon guidelines, policies & procedures
• Partner with Patient Advocacy Organizations in a compliant manner to integrate the patient voice into scientific and medical communications
• Deliver education on Annexon’s science and product data to P&T committees, formulary decision makers, and local, regional and national payers in accordance with all laws, regulations, and Annexon’s guidelines, policies, and procedures, while aligning with medical affairs and Annexon’s overall strategy
• Develop and execute tailored TL and HCP scientific engagement plans as needed
• Engage with TLs, trial investigators, and research staff, to support Clinical Development and Clinical Operations activities including but not restricted to identification of viable study sites, facilitation of participation in clinical trials, and patient recruitment
• Ensure strong, compliant collaboration with cross-functional field partners
• Serve as the Medical Expert and a field representative for Medical Directors with TLs, investigators, and other cross-functional partners

Education, Experience, and Skills: 

Required: 

• Scientific, healthcare or medical degree (PharmD, PhD, MD, DO)
• FMD requires 4 to 6 years of field-based experience in biopharmaceutical industry in medical affairs or relevant clinical roles and FMSD requires 6+ years of experience
• Prior experience as a Medical Science Liaison within Ophthalmology, with demonstrated expertise in retinal or ocular diseases and established relationships with key opinion leaders (KOLs) in the space.
• Scientific and patient-centric mindset with a successful track record of delivering results exceeding objectives in support of medical affairs and Annexon strategies
• Strong communication and presentation skills as evidenced by the ability to rapidly analyze complex scientific and medical data and synthesize for effective communication to audiences with diverse backgrounds
• Demonstrated ability to build scientific relationships with TLs, clinicians, researchers, and other relevant internal or external stakeholders
• Able to effectively collaborate within a matrix organization and cross functional teams
• Solid knowledge of the healthcare landscape inclusive but not limited to hospital systems, various points of care, and the roles of relevant HCPs in the target TAs
• Solid knowledge of the drug development process, and the role of various internal and external stakeholders in various phases of R&D
• Able to document insights, TL engagement and complete all administrative tasks in a timely fashion
• Capable of working independently to prioritize tasks, develop and implement action plans, and make sound, compliant decisions
• Strong understanding of compliance, and the legal and regulatory landscape as they relate to HCP interactions
• Flexible to travel within assigned region based on business needs and occasionally nationally or internationally

Location: Central Plains Region / Remote Field Based (includes onsite travel to Annexon – HQ) 

Level: This role may be filled at the Associate Director or Director level, depending on the candidate’s experience and qualifications 

Salary Range: ($190,000 - $224,000) 

Benefits: 

• A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
• Shuttle service from BART, CalTrain and the Ferry.
• Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, and other benefits. 

Annexon Biosciences is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind.  We are committed to fostering an environment where ALL people are welcome and supported. We cultivate a culture of inclusion for all employees that respects their individual strengths, views, and experiences. We believe that our differences enable us to be a better team – one that makes better decisions, drives innovation, and delivers better business results. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect. 

About the Role >>> Director, Clinical Monitoring Oversight 

As the Director, Clinical Monitoring Oversight, reporting to the Senior Director, Clinical Operations, you will provide strategic and operational leadership for global clinical site monitoring activities across Olema’s clinical programs. You will ensure that clinical monitoring – whether by internal teams, through Functional Service Providers (FSPs), or outsourced to Clinical Research Organizations (CROs) – is executed with high standards of quality and consistency while maintaining compliance with GCP regulations. You will oversee Olema’s Clinical Monitoring Oversight Leads, regional monitoring teams, and site performance. As the Director, Clinical Monitoring Oversight, you will develop and implement monitoring oversight strategies and standards for Olema’s clinical monitoring execution worldwide—driving operational excellence, data integrity, and inspection readiness across all trials with an emphasis on risk-based, data driven processes. 

This role is based out of either our Boston, MA or San Francisco, CA office and will require about travel 15% travel.  

Your work will primarily encompass: 

• Provide strategic direction and operational oversight of all global monitoring activities across Olema’s clinical programs 
• Oversee internal clinical monitoring oversight team and FSP vendor responsible for providing Regional Site Monitoring Leads (RSMLs), ensuring alignment, consistency, and accountability across global regions 
• Establish and maintain effective governance with the FSP partner, including performance management, risk mitigation, and continuous improvement in monitoring quality and efficiency 
• Define and implement Olema’s monitoring strategy, including risk-based and centralized monitoring approaches in alignment with ICH-GCP and regulatory expectations 
• Ensure global harmonization of clinical monitoring processes, training, and documentation across programs and regions 
• Develop and monitor key performance indicators (KPIs) and quality metrics to evaluate site performance, FSP delivery, and regional oversight effectiveness 
• Collaborate with Clinical Operations, Data Management, Clinical Quality, and Clinical Development to ensure monitoring activities are aligned with program objectives and timelines 
• Contribute to the development and review of key operational documents, including Monitoring Plans, Oversight Plans, Risk Management Plans, and audit/inspection responses 
• Proactively assess monitoring risks and implement mitigation strategies to maintain inspection readiness 
• Lead, manage, and mentor internal monitoring oversight staff, fostering collaboration, accountability, and continuous improvement 
• Serve as the Monitoring Oversight representative on cross-functional and governance teams, presenting program updates, risks, and mitigation strategies to senior management 
• Drive innovation and process optimization in monitoring oversight practices, including leveraging technology and data analytics to enhance quality and efficiency 

 Ideal Candidate Profile >>> 

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor's or Master’s degree in a scientific discipline or a related scientific field is required 
• Strong understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements related to monitoring and clinical trial conduct 

 Experience: 

• Minimum 12 years of clinical operations experience in the pharmaceutical or biotech industry 
• Minimum 5 years direct site monitoring experience (qualification, initiation, interim, and close-out visits) with strong understanding of site operations and clinical trial execution 
• Minimum 5 years in a role providing global monitoring oversight, including oversight of clinical site monitors, FSP/CRO management and oversight, monitoring quality metrics, KPIs, and governance, and a track record of driving performance improvement and corrective action plans 
• Experience overseeing regional monitoring functions and ensuring alignment across geographically distributed teams 
• Oncology experience is required  

 Attributes: 

• Demonstrated ability to manage FSP or CRO partnerships, including contract governance, KPI development, and issue escalation 
• Skilled in risk-based monitoring methodologies and the use of oversight tools and systems 
• Strategic thinker with excellent communication, leadership, and interpersonal skills, with the ability to influence cross-functionally and externally 
• Strong analytical and problem-solving abilities; adept at managing competing priorities in a fast-paced environment 

The base pay range for this position is expected to be $235,000 - $250,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-CK1

The Clinical Trial Manager (CTM) is responsible for the oversight and management of all clinical operational activities at the trial and site level. The CTM will interact well with the Heartflow Clinical Research staff and collaborate effectively with Heartflow onsite and field staff, clinical research coordinators, principal investigators, and vendors to aid in ensuring clinical studies meet or exceed timelines and maintain high quality standards. The CTM will have demonstrated experience with clinical research study execution, exceptional organizational skills, excellent attention to detail, and will be comfortable working in a fast- paced start-up culture.

Job Responsibilities:

• Participates in clinical research activities including management of clinical study sites, management of study documentation, vendor management, and completion of project management tasks
• Develops clinical trial timelines, enrollment projections, and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans
• Participates in and leads process improvement activities within the department and cross functionally, including SOP development
• Conducts study start-up activities including the development of protocols, informed consent forms, source document worksheets, training presentations, etc.
• Reviews site regulatory documents (informed consents, IRB approvals, research agreements) to ensure compliance with study requirements and GCPs
• Maintains effective working relationships with investigators/investigational site research coordinators, and vendors including core labs and data management
• Perform other duties as required for successfully completing studies, as necessary

Skills Needed:

• Ability to work in a smaller team environment with a willing, all hands on deck attitude
• Ability to manage multiple tasks and be comfortable working in an environment with shifting priorities
• High attention to detail, accuracy, and quality and able to effectively prioritize multiple projects
• Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
• Excellent written and oral English communication skills required
• Proficiency in computer programs and specifically in Microsoft office tools including Word, Excel and PowerPoint

Educational Requirements & Work Experience:

• Bachelor’s degree in science or health related field
• Demonstrated 5 years minimum relevant experience required
• Experience in cardiovascular medical device clinical research a plus

Travel required: up to 25%

A reasonable estimate of the base salary compensation range is $110,000 to $150,000, cash bonus. #LI-IB1; #LI-Hybrid

Role Overview 

The Senior Director, Clinical Operations is responsible for directing the strategy, management, and oversight of clinical program(s) and functional activities as assigned.  

Key Responsibilities 

• Acts as Clinical Operations program lead for assigned program(s) 
• Represent Clinical Operations at the Clinical Development Team and/or Global Program Team
• Develops and executes program operational strategy 
• Partners closely and effectively with other functions and functional heads to drive program forward 
• Provides strategic and technical recommendations to senior leadership 
• Directs the selection of CROs and other vendors (IxRS, Central Lab, ancillary/tech vendors) 
• Acts as an escalation point for CRO/vendor issues 
• Directs development of vendor Scopes of Work (SOW), scope changes, budgets, and vendor payments 
• Partners with CRO and other vendors to deliver on study execution 
• Creates and tracks clinical program budgets 
• Directs risk mitigation, escalation, and resolution activities both internally as well as with sites and vendors 
• Directs technical and strategic input into the development of clinical documents (protocols, monitoring plans, informed consent forms, investigator brochures, clinical study reports, etc.)  
• Builds relationships with clinical sites, vendors, and key stakeholders  
• Maintains understanding of external landscape and adjusts plans accordingly 
• Represents Clinical Operations in cross-functional activities as assigned 
• Plays a key role in the development and management of the Clinical Operations function; may act as a deputy for the Head of Clinical Operations as assigned 
• Hires, manages, coaches, and mentors staff 
• Contributes to building the organization 

Qualifications 

• Bachelor's degree in a related field required, an advanced degree is a plus 
• 17+ years of clinical research experience, including 10+ years of trial and/or program-level management within a biopharmaceutical company, and 3+ years of line management experience 
• Exceptional clinical trial & program management skills with a focus on strategic oversight of program execution on time and on budget 
• Extensive experience selecting and managing vendors, including CROs, labs, IxRS, EDC, and ancillary technology/applications (e.g. eDiaries, eConsent, apps, etc) 
• Thorough knowledge and understanding of FDA and ICH Guidelines, GCP, medical terminology, and clinical trials 
• Detailed understanding of all aspects of clinical protocol design, implementation, IND/BLA/NDA submissions, and overall drug development  
• Experience managing, coaching, and mentoring personnel 
• Excellent communication, organizational, negotiation, and interpersonal skills with a strong reputation for collaboration 
• Able to drive decisions forward in times of ambiguity or with incomplete information 
• Effective in promoting and maintaining productive internal and external relationships 
• Proven leadership and team building skills, along with success in proactive risk mitigation and problem solving 
• Flexible and creative to meet the needs and challenges of a growing, dynamic company 
• Demonstrated problem solving abilities 
• Proven ability to influence up, down, and across the organization 
• Strong financial acumen with outstanding track record of building budgets and managing expenses to budget 
• Study coordinator and/or site monitoring experience a plus 
• Thrives in a small company environment, where day-to-day duties go above and beyond this job description 
• May contribute to corporate activities, e.g. preparation for Board of Director meetings 

Position Location 

This is a remote role; periodic travel to team and company events is required. 

The anticipated salary range for candidates for this role is $255,000 – $280,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. 

As part of the I-9 verification of authorization to work in the United States, Jade Bioscience participates in E-Verify. To learn more about E-Verify please review this poster. 

Jade Biosciences is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. 

Role Overview 

We are seeking highly skilled, and motivated Director of Combination Product & Device Development, to lead the development, manufacturing, assembly and commercialization of high‑concentration biologic delivery systems, including, prefilled syringes, autoinjectors and other drug–device combination products.

The ideal candidate brings deep expertise in device design control, verification and validation, risk management, combination product regulations, and human factors engineering. This role requires hands‑on technical leadership and extensive experience with regulated devices and combination products (21 CFR 820, ISO 13485), as well as strong knowledge of global device standards (ISO, IEC 62366, ANSI/AAMI HE75) and FDA guidance. A successful track record supporting major regulatory submissions (BLA, MAA, IND/IMPD) and notified body assessments is essential.

Key Responsibilities 

Device Development

• Lead end‑to‑end development and commercialization of prefilled syringes, dual‑chamber cartridges, autoinjectors, and related combination product systems.
• Serve as a hands‑on technical leader and device SME across concept, feasibility, development, qualification, and launch phases.
• Define user needs and product requirements; lead prototyping, test method development, and design verification and validation (DV/V) activities.
• Drive design control documentation, risk assessments, usability studies, and human factors integration.
• Collaborate deeply with internal partners across CMC, drug product development, quality assurance, regulatory affairs, clinical development, supply chain, and commercial functions.
• Build and manage external relationships with CDMOs, device manufacturers, design firms, and suppliers to support development and lifecycle needs.
• Support lifecycle management of commercial combination products, including design history file (DHF) maintenance, change control, validation activities, complaint investigations, and post‑market surveillance.
• Evaluate technical decisions for cross‑functional impact and implement contingency plans as needed.
• Proactively identify and address manufacturing issues; coordinate technical solutions across internal and external teams.
• Lead creation of design control deliverables to ensure compliance with global device and combination product regulations.
• Oversee development of statistically sound verification protocols, reports, and design validation strategies.
• Lead or contribute to investigations of deviations, failures, complaints, and device‑related quality issues.

Design Controls & Human Factors

• Serve as the organizational expert in Human Factors Engineering, ensuring compliance with IEC 62366, ANSI/AAMI HE75, FDA guidance, and related industry standards.
• Integrate usability, human performance considerations, and safety risk mitigations into system requirements and development strategies.
• Ensure all human factors processes, deliverables, and standards are appropriately documented within the Design Control Quality System.
• Lead the cross‑functional design control sub‑team and drive cohesive integration across device design, analytical testing, packaging, manufacturing, clinical, supply chain, commercial, and regulatory functions.
• Manage and prioritize multiple concurrent projects, ensuring alignment to scope, timelines, budgets, and quality standards.

Regulatory Support

• Ensure compliance with global combination product and medical device regulations, including FDA and EU frameworks (e.g., EDDO, MDR).
• Author device‑related sections for regulatory submissions (BLA, MAA, IND/IMPD) and support notified body interactions.
• Represent the combination product function during regulatory audits and inspections.
• Lead proactive risk identification, mitigation planning, and escalation of critical issues.
• Demonstrate strong understanding of FDA’s Office of Combination Products (OCP), including primary mode of action (PMOA) requirements and combination product complaint expectations.

Qualifications 

• Master’s degree (or equivalent) in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or a related field.
• 15+ years of experience in biologic delivery device development with a proven record of supporting late‑stage development and commercial product launches.

• Experience with design controls, device risk management, medical devices, prefilled syringes, autoinjectors, and related scientific and technical concepts and techniques is required for this position.
• Deep knowledge of subcutaneous delivery systems, systems engineering principles, device materials, and manufacturing technologies; experience with biologics and packaging development preferred.
• Strong understanding of FDA and EU regulations for medical devices and combination products, including relevant quality systems and standards.
• Experience managing external partners, vendors, and contract manufacturers.
• Proven experience with cGMP process development, manufacturing controls, and process risk assessments.
• Excellent communication, leadership, and cross‑functional collaboration skills.
• Ability to thrive in a fast‑paced, agile environment; start‑up experience is highly desirable.

Position Location 

This is a fully remote role with up to 15-20% domestic and/or international travel.

The anticipated salary range for candidates for this role is $210,000 - $235,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. 

Role Overview 

We are seeking a Director of Clinical Supply Chain to lead end-to-end clinical supply execution for a global late-stage clinical trial. This role will have full ownership of clinical supply strategy and execution, from demand forecasting through distribution, for programs involving prefilled syringes (PFS) and autoinjectors. The successful candidate will be comfortable operating within a fast-paced environment and partnering closely with Clinical Operations, Quality, CMC, and external vendors to ensure uninterrupted drug supply for our studies. This is a great opportunity to own a critical late-stage program with real patient impact and to have the ability to shape clinical supply strategy during a pivotal stage of the company’s evolution.

Key Responsibilities 

Clinical Supply Strategy & Execution

• Own the global clinical supply strategy for late-stage programs, including demand forecasting, inventory management, and risk mitigation.
• Develop and maintain integrated supply plans aligned with enrollment forecasts, dosing schedules, and protocol amendments.
• Ensure seamless transition and continuity of drug supply.

Drug Product Development

• Lead clinical supply activities for vials, prefilled syringes (PFS), and autoinjectors, including:
• Device assembly and packaging considerations
• Cold-chain (2–8°C) requirements
• Labeling, blinding, and re-supply strategies
• Partner with CMC and device vendors to support lifecycle changes, comparability, and scale-up impacts to clinical supply.

Vendor & Depot Management

• Manage external partners including:
• Packaging and labeling vendors
• Global depots and regional distribution hubs
• Couriers and specialty logistics providers, as appropriate
• Lead vendor selection, SOWs, budgets, timelines, and performance oversight.
• Ensure qualified shippers, temperature monitoring, excursion management, and deviation handling are done in a compliant manner.

Distribution & Regulatory Compliance

• Oversee global distribution across multiple regions, ensuring:
• Country-specific import/export requirements
• QP release and EU clinical supply compliance where applicable
• Ensure inspection-ready documentation and robust supply chain traceability.

Cross-Functional Leadership

• Serve as the clinical supply chain lead on cross-functional study teams.
• Partner closely with:
• Clinical Operations on enrollment and site strategy
• Quality on GMP/GDP compliance and deviations
• Regulatory and CMC on changes impacting supply
• Communicate risks, mitigations, and trade-offs clearly to senior leadership.

Qualifications 

• Bachelor’s degree and 15 years of experience or a master’s degree with 12+ years of experience
• 10+ years of experience in clinical supply chain / clinical supply operations.
• Direct experience managing Phase 3 clinical trials, including global distribution.
• Hands-on experience with prefilled syringes (PFS) and/or autoinjectors in a clinical trial setting.
• Demonstrated ownership of:
• Forecasting and supply planning
• Packaging, labeling, and distribution
• Vendor and depot management
• Strong understanding of GMP/GDP, ICH-GCP, and global clinical supply requirements.
• Cold-chain biologics experience (2–8°C).
• Experience transitioning programs toward commercial readiness.
• Demonstrated ability to balance strategy and execution.
• An ownership mindset, ability to anticipate risk and solve problems proactively.
• Clear communication skills and the ability to translate supply complexity into actionable decisions.

Position Location 

This is a remote role; periodic travel to team and company events is required. 

The anticipated salary range for candidates for this role is $210,000 - $235,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. 

Role Overview 

The Associate Director, Quality Control will lead critical Quality Control functions to support Jade’s product pipeline across various stages of development. The Associate Director will manage analytical method life cycle including method development, qualification, transfer and validation as phase appropriate. This individual will work very closely with internal stakeholders and external CDMO partners and will be responsible for developing and executing product release testing, stability study and product shelf-life management strategy whileensuring full quality compliance with regulatory requirements and internal quality systems.

Key Responsibilities 

• Work with both internal (Manufacturing, Quality Assurance, Regulatory and other key stakeholders) and external CDMO partners to develop and implement QC strategies appropriate for different phases of development programs
• Oversee analytical method development, qualification, transfer and validation activities at and cross CDMOs

• Develop product specifications and oversee product in-process, release, and stability testing strategy and execution in compliance with both cGMP and ICH guidance and internal quality standard
• Work with Quality Assurance to create and manage QC documentation including SOPs, protocols, and technical reports
• Collaborate cross-functionally with Manufacturing, QA, Regulatory, and R&D to support tech transfers and lifecycle management, regulatory filing and interactions etc.
• Manage CDMO relationships to ensure compliance with quality standards, timely deliverables, and effective communication
• Review and approve CDMO generated data, investigations, and documentation
• Ensure timely investigation and resolution of OOS results, deviations, and CAPAs
• Serve as QC subject matter expert during regulatory inspections and audits

Qualifications 

• Master’s or advanced degree in Chemistry, Biology, Biochemistry, or related field with 10+ years of related experience (7+ years of experience with PhD)

• 8+ years of experience in Quality Control management within the biotech or pharmaceutical industry
• A strong quality compliance and collaborative mindset, and ability to thrive in a fast-paced working environment
• Strong knowledge of cGMP, FDA, EMA, and ICH regulations
• Strong experience in analytical method life cycle management including phase appropriate method qualification, transfer and validations from early to late phase development including BLA filing
• Experience with common analytical techniques such as HPLC/UPLC, CE-SDS, ELISA, and cell-based assays for biologics development
• Proven leadership in managing internal QC operations or external CDMOs  
• Excellent communication, organizational, and problem-solving skills

Position Location 

This is a fully remote role with up to 20% domestic and/or international travel.

The anticipated salary range for candidates for this role is $170,000 - $190,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. 

Role Overview 

The Associate Director, Clinical Site Budgets & Payments will architect and lead the company’s global approach to clinical trial site budgeting, investigator grant strategy, transparency compliance, and site/vendor payment governance across our clinical trial portfolio. This leader will define Jade’s global investigator grant philosophy, including structured opening offer and negotiation parameters that ensure speed, fairness, and alignment with global FMV benchmarks.  They will establish standards for invoiceables, conditional procedures, pass‑through costs, and country‑specific budgeting norms that apply across all Jade clinical studies.

This role oversees a full‑service CRO partner responsible for operational execution of budgets, payments, reconciliation, and study financial controls. It also builds and maintains global site budget forecasts, ensures just‑in‑time CRO funding, and supports accruals, reconciliation, and inspection‑readiness.

The successful candidate must be equally fluent in clinical trial protocols and financial statements, highly skilled in influencing cross‑functional and vendor partners, and able to uphold strict compliance with FMV and Sunshine/Open Payments regulations. This is a high‑visibility, individual‑contributor role reporting directly to the Executive Director, Development Outsourcing and operating globally across all Jade studies. The position is remote, with domestic travel up to four times per year.

Key Responsibilities 

Global Payment Philosophy, Compliance & Governance

• Define Jade’s global investigator grant strategy, including opening‑offer tiers, decision and negotiation parameters, aligned with international FMV standards.
• Establish and maintain policies for invoiceables, pass‑throughs, conditional procedures, screen‑fail handling, and complex visit structures; ensure global consistency.
• Develop and maintain SOPs/WIs governing budgeting, payments, documentation, and global transparency requirements (e.g., U.S. Sunshine/Open Payments and ex‑US equivalents).
• Define FMV justification expectations and ensure audit‑ready documentation across all investigator/HCP engagements.

Study‑Level Budget Design & Financial Oversight

• Translate clinical protocols into country‑specific and site‑level cost models that accurately reflect procedures, visit schedules, and conditional events.
• Build and maintain global study budget forecasts, partnering closely with Clinical Operations and Finance to ensure alignment with development plans.
• Implement and monitor just‑in‑time CRO funding, minimizing idle cash at CROs while ensuring on‑time site payments.
• Oversee accruals, spend tracking, payment reconciliation, and close‑out documentation for accuracy and inspection readiness.

CRO Governance & Issue Escalation

• Serve as Jade’s primary owner of CRO performance for site budgets and payments, including contract expectations, KPIs, and service delivery standards.
• Lead the payment‑related components of CRO governance forums, including issue resolution, aging analysis, cycle‑time performance reviews, and payment forecasting.
• Resolve escalated site payment issues, driving sustainable root‑cause solutions and process improvements.

HCP/KOL Payment Operations (“White‑Glove” Model)

• Implement a high‑touch service model for KOL/HCP payments (consulting, advisory boards, speaking engagements), ensuring accuracy, speed, and FMV alignment.
• Streamline administrative burden for external experts by simplifying processes, documentation, and support.

Cross‑Functional Leadership & Decision Support

• Partner closely with Clinical Operations, Development Outsourcing, Legal, Compliance, and Finance to ensure budgets and payments reflect protocol intent, operational realities, and compliance needs.
• Provide executive‑level visibility into performance metrics such as payment timeliness, disputes, forecast accuracy, and CRO funding utilization.
• Serve as Jade’s internal subject‑matter expert for investigator/HCP budgeting and payment strategy across a global two‑program portfolio in Autoimmune disease.

Qualifications 

• Bachelor’s degree in finance, life sciences, business, or related field with 13+ years of experience or an advanced degree (MBA, MS, MPH) with 10+ years of experience.
• 10+ years of relevant experience in biotech/pharma or CRO roles with direct responsibility for site budgeting and payment oversight
• Demonstrated ability to interpret clinical protocols and convert them into robust, compliant global site budgets
• Strong understanding of global FMV frameworks and Sunshine/Open Payments transparency requirements.
• Proven experience governing a full service CRO, including KPI management, escalation handling, and process improvement.
• Ability to analyze financial statements, accruals, and cash flow impacts.
• Excellent communication, negotiation, and cross functional influence.
• Experience supporting Autoimmune or immune mediated diseases preferred.
• Experience managing global payment models across diverse regulatory environments preferred.
• Exposure to KOL/HCP engagement processes with FMV and transparency considerations preferred.

Position Location 

This is a remote role; periodic travel to team and company events is required. 

The anticipated salary range for candidates for this role is $170,000 - $190,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. 

THE ROLE

The Director, Clinical Operations will lead the strategic planning, execution, and continuous improvement of Septerna’s clinical programs across multiple therapeutic areas. This role is pivotal in a dynamic, fast-growing biotech environment and will ensure our clinical trials are delivered with excellence—on time, within budget, and in compliance with regulatory and quality standards.

This is an exciting opportunity with significant room for growth and visibility across the organization. The Director will work closely with senior leadership and cross-functional teams, gaining exposure to all levels of the company while helping to shape the future of Septerna’s clinical operations. The ideal candidate combines deep operational expertise with a patient-first mindset, thrives in collaboration, and brings creativity and structure to a scaling organization.

Key Responsibilities

• Lead operational planning and execution of clinical programs (Phase I–III, including patient-facing , global studies) in alignment with development goals.
• Oversee end-to-end delivery of clinical trials: define timelines, budgets, risk mitigation, resource allocation, and monitoring of results.
• Select, contract, and manage CROs and external vendors; build strong vendor relationships, ensure accountability to scope, budget, milestones, and quality.
• Collaborate across functions — Clinical Development, Regulatory, Biometrics/Data, QA,  — to ensure aligned execution and streamlined decision-making.
• Build and mentor a growing clinical operations team; drive team development, foster a culture of learning, accountability, innovation, and high performance.
• Drive operational excellence by creating and implementing fit-for-purpose processes, systems and tools that support a scaling organization — standardizing templates, SOPs, dashboards, KPIs.
• Demonstrate ability to quickly adopt new therapeutic areas, adapt to evolving science and growing strategic demands.
• Bring creative, out-of-the-box thinking to optimize trial design, site operations, patient engagement, vendor strategies and operational efficiency.
• Ensure inspection readiness and adherence to ICH-GCP, SOPs and global regulatory standards; partner with QA to maintain operational integrity.
• Establish and track meaningful metrics (KPIs) to manage progress, proactively manage risks, and drive continuous improvement in trial efficiency and data quality.

Qualifications

• Advanced degree (MS, PharmD, PhD) preferred; or bachelor’s degree in life sciences/clinical research with equivalent robust experience.
• Minimum 10  years’ experience in clinical operations in biotech or pharma, with leadership of multiple global clinical programs (including patient-facing studies).
• Demonstrated success in building and mentoring teams; experience in a growing/scaling environment is highly desirable.
• Proven track record managing CROs/external vendors, budgets/timelines, and operational delivery in a complex setting.
• Effective cross-functional collaborator; strong communicator able to navigate a matrixed, fast-moving organization.
• Experience in or ability to quickly learn new therapeutic areas (endorcrinology, immunology/inflammation, metabolic disease or similar) is strongly preferred.
• Demonstrated process-orientation: able to build, refine and standardize systems, tools, SOPs, dashboards and metrics.
• Strategic thinker with proactive, solution-driven mindset; able to bring innovative thinking to trial operations.
• Results-oriented, detail conscious, and adept at managing multiple priorities under deadlines.

The anticipated salary range for candidates who will work in South San Francisco, CA is $225,000 - $250,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.

The Position

At Maze Therapeutics, we believe that precision medicine has the power to transform the lives of patients with both common and rare diseases. As a Senior Clinical Trial Specialist (Sr. CTS) at Maze Therapeutics, you’ll play a key role in supporting our Clinical Operations team as we deliver an exciting clinical trial in the rare disease, Phenylketonuria (PKU). You’ll collaborate closely with internal teams, CROs, and vendors to ensure the smooth execution of our clinical studies. This role is best suited for someone who is organized, detail-oriented, and proactive. The ideal candidate enjoys problem-solving, thrives in a fast-paced environment, and is eager to take ownership of critical trial activities such as vendor and site management.

The Impact You’ll Have

You’ll be a critical part of our clinical team, ensuring our trials are executed with precision, efficiency, and the highest standards of quality. Your contributions will include:

• Driving Study Execution: Partner with the Clinical Operations team to oversee and monitor the conduct of our global Phase 2 PKU study, monitoring and tracking progress, identifying trends or issues, and collaborating with Study Leads to implement corrective actions when necessary.
• Site, Vendor Management & Oversight:
  • Lead site management oversight (e.g., reviewing reports, conducting QC checks, escalating trends to Global Site Manager) to ensure CRO activities align with the study plans and protocol. Facilitate any deviation discussions for quick resolution. Identify site trends, opportunities for training, and creating tracking tools to ensure sponsor oversight.
  • Manage one or more clinical trial vendors from study-start to close-out, including day-to-day management, budget oversight, and escalating to Study Lead as, appropriate.
  • Identify gaps quickly, hold vendors/CRAs accountable, provide solutions, and escalate risks in a timely manner.
• Ensuring compliance & Best Practices: Ensure that all clinical trial activities adhere to ICH/GCP Guidelines, study plans and protocols, and Maze SOPs.
• Supporting Key Study Materials: Assist in the design, development, and review of study documents, including protocols, informed consent forms (ICFs), amendments, and content creation for study materials.
• Collaboration & Leadership: Attend and contribute to vendor meetings, lead resolution of study-related issues, and foster a culture of continuous process improvement with CROs and other external partners.
• Tracking & Documentation: Oversee Trial Master File (TMF) activities, ensuring proper documentation, metric tracking and reconciliation efforts as needed.
• Sample & Data Management: Work with study team to coordinate and track sample shipments, sample analysis, and data reconciliation efforts.
• Cross-Functional Collaboration: Serve as a point of contact for study-related inquiries and provide high-level administration, coordination, and organizational support to the Clinical Operations team.
• Process & SOP Development: Contribute to creation and refinement of Clinical Operations standard operating procedures (SOPs) and process documents to optimize study execution.

What We’re Looking For

We’re looking for someone who’s not just checking the boxes but is truly passionate about bringing high quality clinical trials to life. You might be a great fit if you have:

• A strong clinical operations background: Bachelor’s degree with 2-3+ years of experience in Clinical Operations within a biotech or pharmaceutical environment.
• A systematic and problem-solving mindset: You enjoy solving complex challenges and thinking critically to improve processes.
• Exceptional organizational skills: You can manage multiple priorities, staying detail-oriented, and keep trials on track.
• A proactive and collaborative approach: You’re a strong team player who takes initiative and builds meaningful relationships with internal and external partners.
• Hands-on experience with trial systems: Familiarity with clinical trial databases such as Medidata Rave, Veeva, or similar platforms.
• Flexibility and adaptability: You thrive in a fast-paced, evolving environment and willing to roll-up your sleeves to perform a broad range of clinical trial related tasks as needed.
• Willingness to travel: Up to 10-15% travel, with the possibility of more based on project needs as necessary.
• Strong computer proficiency (Microsoft Office Suite- Word, Excel, Outlook).

This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least two days per week.

About Maze Therapeutics

Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which allows it to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process it refers to as variant functionalization. The company’s pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease.  Maze is based in South San Francisco.

Our People

Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients. 

Our Core Values

Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we’ll achieve our mission. 

Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others.

Stand True – Our integrity is foundational; it guides us no matter the obstacle.

The expected annual salary range for employees located in the San Francisco Bay Area is $125,000 to $152,000. Additionally, this position is eligible for an annual performance bonus. Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future.

Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy.

#LI-Hybrid

We are seeking an experienced Senior Medical Director in Clinical Development who will be involved across the full scope of rheumatology and autoimmune clinical drug development activities from discovery research through first in human, POC, and Phase 3 studies. The role will include leadership of one or more studies within the portfolio and will work closely with all members of the cross-functional asset team, to apply full clinical knowledge to successfully advance clinical programs as well as the overall asset strategy.

Principal Responsibilities 

• Serve as the physician lead for LUMUS, a 388-patient Phase 2b clinical trial designed to evaluate the efficacy, safety, and pharmacokinetics of multiple doses of ESK-001 in adult patients with moderately to severely active, autoantibody-positive SLE. 
• Provide leadership of in-stream data reviews and reconciliation efforts. 
• Hold authorship of clinical portions of key study documents, such as Protocol Amendments and Regulatory Submissions. 
• Provide oversight of the LUMUS medical monitor. • Participates in external scientific engagement, including peer-to-peer interactions with MDs. 
• Broadly represent the interests of Alumis as a leader, supporting corporate initiatives across rheumatology.
• Coach, manage, inspire, and support team members to achieve goals by leveraging a focused and collaborative mindset. 
• Maintain the highest levels of integrity and standards for scientific inquiry in drug development. 

Primary Goals During the opening months on the job, this Senior Medical Director will be expected to focus on the following objectives: 

1. Earn the full trust and respect of key internal and external stakeholders by establishing a reputation as a strategic and highly productive partner.

2. Provide hands-on leadership, apply knowledge and expertise, and partner seamlessly with the operations team to help make LUMUS thrive.

3. Focus on improving and maintaining study data quality, including cross-referencing of the main efficacy endpoints.

Candidate Requirements

• MD (or ex-US equivalent) with board certification in Rheumatology.
•  5+ years of clinical development experience; having a background in lupus clinical trials is desired.
•  Proven leadership skills, as evidenced by having managed people within a pharmaceutical company or in a clinical/academic environment.
•  Ability to assess, understand, and communicate continuously expanding medical and scientific information.
•  Proven professional track record of strategic, organizational, and executional skills to support project planning across multiple activities, with the ability to anticipate and prioritize one’s workload across multiple projects of equal importance.
•  Proven ability to approach deliverables in an organized manner with attention to detail and to meet timelines in a fast-paced environment.
•  Established ability to work across diverse teams in a matrixed organizational structure, both as a leader and as part of a cross-functional team.
•  Strong interpersonal, influencing, presentation, and communications skills (both written and verbal) to effectively address all levels within an organization.
•  Ability to work autonomously and with a high level of independence.
•  Willingness to travel to Alumis’ HQ in South San Francisco for one week out of every month

The salary range for this position is $300,000 USD to $358,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.

This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday. Open to remote applicants with requirement to be onsite once a month.

Alumis Inc. is an equal opportunity employer.

Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.  

Other benefits include:

• Health insurance premiums paid at 90% for employee, 80% for dependents
• Free access to Genentech Bus & Ferry Share program
• $100 monthly cell phone stipend
• Unlimited PTO for Exempt employees
• Free onsite gym and a kitchen stocked with yummy snacks and drinks!

We are a hard-working, collaborative team on a mission to transform patient’s lives-- and we aspire to elevate, challenge and nurture one another along the way.

Senior Manager, Pharmacovigilance Safety Operations

The Senior Manager, Pharmacovigilance (PV) Safety Operations will report to the Director, PV Safety Operations. This role will play a critical role in ensuring timely reporting, processing, and submission of ICSRs from ongoing clinical trials and post-marketing trials. This role involves overseeing case processing vendors, managing ICSR process, collaborating with cross-functional teams study execution teams, assisting with inspection readiness activities, all while compliance with regulatory requirements.

Essential Responsibilities

ICSR Operational Excellence/Vendor Oversight

• Provide end-to-end operational oversight of ICSR intake, processing, follow-up, quality control, and submissions performed by our outsourced PV vendors.

• Ensure accurate and timely processing of ICSR to ensure accuracy and consistency, and compliance with Alumis standard operating procedures (SOP) and PV system expectations.

• Lead the development and maintenance of safety management plans and submission tracking systems.

• Support the development and maintenance of SOPs.

• Coordinate internal medical review activities in collaboration with medical case reviewers.

• Monitor case flow to ensure timely exchange for submissions.

• Review operational trends and quality indicators to proactively identify risks and drive corrective actions.

• Collaborate with clinical operations, data management, and PV teams to perform database reconciliation for clinical trials.

• Track the submission of safety reports to regulatory authorities and ensure compliance with country or regional submission deadlines.

• Ensure all safety operations are conducted in compliance with FDA, ICH, and other relevant regulatory guidelines.

Cross-Functional Collaboration

• Work closely with clinical development, regulatory, and quality assurance teams to align safety operations with overall study objectives and ensure regulatory compliance.

• Assist in the preparation of new clinical trials study start up activities such as review Safety sections of clinical trial protocols, Informed Consent Forms, clinical database configurations, including User Acceptance Testing and Safety Case Report Forms.

• Collaborate with Safety Surveillance and assist in the preparation of surveillance meeting materials from safety operation perspective and assist with the development of aggregate reports, such as Development Safety Update Report (DSUR), Periodic Adverse Drug Experience Report (PADER), Periodic Benefit-Risk Evaluation Report (PBRER) by performing various activities such as quality control.

• Contribute to PV system audit-readiness and support inspections activities.

The Ideal Candidate

• Bachelor’s degree in life sciences, pharmacy, or a related field.

• Minimum of 7+ years of experience in safety operations in the biopharmaceutical industry.

• Experience with early and late-stage clinical trials (Phase 3) and post-marketing are highly desirable.

• Experience with device safety reporting and regulatory inspections is a plus.

• Strong knowledge of regulatory requirements (e.g., FDA, ICH guidelines) and industry standards related to drug safety and case processing.

• Demonstrated experience in vendor oversight, submission tracking, and quality control.

• Excellent organizational, analytical, and communication skills.

• Ability to work independently and collaboratively in a fast-paced environment and manage multiple projects simultaneously.

• Leads self by managing and executing own work to deliver results that contribute to accomplishing common department goals

• Proficiency in safety databases and software tools (e.g., Oracle Argus, ARISg, MedDRA).

This role is anchored at our South San Francisco, CA headquarters, with an expectation to be onsite Tuesday through Thursday. While we prefer local candidates, remote applicants based in the Pacific Time Zone will be considered on a case-by-case basis with the ability to travel to HQ approximately once per month, or as business needs require.

The salary range for this position is $170,000 USD to $200,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.

Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. 

We are seeking an experienced Regional Director of Medical Science Liaisons (MSLs) with expertise in medical dermatology. The successful candidate will be responsible for leading and overseeing MSLs, ensuring the effective dissemination of scientific and clinical information, building relationships with key opinion leaders (KOLs), and supporting the strategic goals of the Medical Affairs organization. This role will require a deep understanding of medical science, excellent leadership capabilities, and a strong ability to drive the success of cross-functional teams. We will be seeking one individual for the Western US and one for the Eastern US.

Responsibilities:

Field-based Leadership of Regional DPEGs and IDNs

Serve as primary point of contact with the clinical leaders, educational leaders, and C-suite executives of Dermatology Private Equity-backed Groups, DPEGs, to build trusting professional relationships

Develop deep understanding of DPEG structures, performance metrics, and educational needs

Develop cross-functional engagement strategy to build the groundwork for launch

Co-create data-driven value proposition to improve patient outcomes

Leadership & Team Management:

Lead, mentor, and manage a team of MSLs, fostering a collaborative, high-performing, and scientifically rigorous culture.

Provide guidance on the development and execution of territory plans, objectives, and key performance indicators (KPIs) for each MSL.

Conduct regular performance evaluations, identify skill gaps, and support MSL development through coaching, training, and career growth opportunities.

Collaborate with the Medical Affairs leadership team to align MSL activities with organizational priorities and strategic initiatives.

Strategic Planning & Execution:

Contribute to the development of MSL tactics in line with corporate and therapeutic area goals.

Drive the execution of MSL tactics within assigned region.

Ensure MSLs are equipped with the latest scientific data and clinical information, and support their integration into both regional and national-level initiatives.

Scientific Exchange & KOL Relationship Management:

Cultivate strong, long-lasting relationships with KOLs, healthcare providers, academic researchers, and key stakeholders through active field engagement in the region.

Serve as a scientific resource and point of contact for KOLs to address inquiries regarding the company’s pipeline, products, and scientific advancements.

Represent the company at scientific congresses, advisory boards, and other relevant forums to enhance scientific and therapeutic understanding.

Cross-Functional Collaboration:

Provide strategic input into the development of clinical trials, publication plans, and other medical activities by leveraging field insights and customer feedback.

Collaborate with the Medical Affairs leadership to ensure appropriate deployment of MSL resources to support clinical, regulatory, and commercial objectives.

Compliance & Reporting:

Ensure all MSL activities are conducted in compliance with regulatory, ethical, and company standards, including GxP (Good Clinical Practice) and HIPAA regulations.

Provide regular updates to MA management on team progress, KOL engagement, and other key initiatives, including metrics on impact and outcomes.

Stay abreast of the competitive landscape and emerging trends in dermatology, rheumatology, and neurology, ensuring MSL activities reflect the latest scientific advancements.

Qualifications:

Education:

o PhD, PharmD, MD, or other advanced degree in a relevant scientific discipline (e.g., Biology, Pharmacology, Medicine).

Experience:

o Minimum of 10 years of experience in Medical Affairs or related scientific roles, with leadership experience in managing a team of MSLs or scientific professionals.

o In-depth knowledge of medical dermatology, including clinical practice, research, and evolving treatment paradigms.

o Proven track record of successful relationship-building with KOLs, HCPs, and key stakeholders within the medical community.

o Experience working in cross-functional teams, with a demonstrated ability to collaborate effectively with commercial, clinical, regulatory, and other business functions.

Skills & Competencies:

o Excellent leadership and team management skills, with the ability to inspire and develop a high-performing team.

o Strong communication, presentation, and interpersonal skills, with the ability to engage effectively with internal and external stakeholders.

o Deep understanding of the pharmaceutical industry, including regulatory and compliance requirements, scientific data dissemination, and product lifecycle management.

o Ability to translate complex scientific information into actionable insights for diverse audiences, including KOLs, healthcare professionals, and internal teams.

o Strong problem-solving, strategic thinking, and decision-making skills.

Travel:

o Willingness to travel extensively (50-75%) as required for KOL engagement, scientific meetings, and team management activities.

Preferred Qualifications:

· Experience in therapeutic areas of medical dermatology.

· Previous experience working in a leadership role within a biopharmaceutical company or a global pharmaceutical organization.

· Familiarity with clinical trial processes, publication planning, and scientific communication in a corporate environment.

The salary range for this position is $220,00 to 250,000 USD annually. This salary range is an estimate, and the actual salary may very based on the Company’s compensation practices degree and background.

This position is primarily remote with travel.

Alumis Inc. is an equal opportunity employer.

Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.  

Other benefits include:

• Health insurance premiums paid at 90% for employee, 80% for dependents
• Free access to Genentech Bus & Ferry Share program
• $100 monthly cell phone stipend
• Unlimited PTO for Exempt employees
• Free onsite gym and a kitchen stocked with yummy snacks and drinks!

We are a hard-working, collaborative team on a mission to transform patient’s lives-- and we aspire to elevate, challenge and nurture one another along the way.

The Director, Data Systems (DS) and Clinical Programming (CP) will be responsible for leading and managing the Clinical Programming function within Data Management (DM). This position will report to the VP, Data Management and Clinical Programming.

Responsibilities: 

• Lead and manage the Data Systems and Clinical Programming function within DM
• Drive the implementation of various technology solutions to augment existing DM processes, optimize efficiency and enhance overall data quality assurance
• Lead and/or participate in AI-related initiatives for DM
• Develop and implement strategies for optimizing data flow, database builds, and integration of external technologies.
• Oversee the validation of the EDC platform, ensuring ongoing system optimization.
• Manage relationships with key external vendors, ensuring alignment with organizational goals.
• Ensure compliance with all relevant data privacy regulations and maintain the security of clinical trial data.
• Ensure DS&CP project deliverables are completed on time and in accordance with quality standards and regulatory requirements.
• Collaborate with other departments to align data strategy with broader organizational goals and objectives.
• Mentor and develop team members, fostering a culture of continuous learning and growth within the team.
• Oversee all SAS clinical programming requests and standardize the clinical programming specification development process.
• Develop and/or maintain Alumis’ standard CRFs and standard edit checks, inclusive of indication-specific standards.
• Develop DS&CP SOPs and Work Instructions.
• Lead the development and/or maintenance of standard vendor Data Transfer Agreements (DTAs).
• Oversee the development and execution of technical initiatives within DM, including the implementation of key data visualizations and dashboards for DM, such as Clean Patient Tracking, data currency, and rolling batch freeze progress.
• Integrate the usage of data analytics within DM to further optimize current processes.
• Provide strategic oversight of high-priority projects, including database builds, user access management, and the release of system updates.
• Participate in EDC, IRT and eCOA User Acceptance Testing (UAT)
• Ensure accurate development and execution of data integrations between EDC, IXRS or additional external vendor data sources
• Ensure DS&CP study-specific documentation is in an inspection-ready state and represent the DS&CP function in inspections as applicable.
• Represent DS&CP in cross-functional meetings as applicable
• Act as a key stakeholder in developing and executing strategies to accelerate drug development through innovative data management practices.

Qualifications: 

• 12+ years of relevant experience and has earned a BS or equivalent degree; MS or MBA a plus
• Experience supporting Ph I-IV clinical trials, both in-house and through CRO partners
• Strong knowledge and experience in EDC and other key technologies (e.g., IXRS, data visualization) 
• Proficiency in CDISC standards (CDASH, SDTM, ADaM)
• Experience with SAS, SQL and/or other clinical programming tools
• Proficiency in clinical research regulations and guidance, including FDA CFR and ICH GCP 
• Depth of experience across all aspects of DM, including but not limited to: CRF and database development, data quality assurance and analytics, data transfer management, vendor management, DM study documentation and inspection readiness. 
• Strong understanding of the application of MedDRA and WHO Drug clinical data coding classification systems
• Strong interpersonal, organizational, and communication (oral and written) skills
• Demonstrated ability to cultivate strong working relationships with internal and external colleagues.
• Logical thinking, attention to detail and accuracy, strong organizational skills, and problem-solving abilities
• Ability to prioritize and to adapt quickly to changing business conditions with a “can-do” attitude
• Capable of proactively identifying project challenges and risks and proposing appropriate and strategic solutions to issues.
• Willing to travel if required  

Alumis Values 
• We Elevate 
• We Challenge 
• We Nurture 

This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday. Open to remote applicants with requirement to be onsite 1-2x a quarter.

The salary range for this position is $200,000 USD to $225,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.

Alumis Inc. is an equal opportunity employer.

Alumis is hiring a Clinical Quality Assurance Director, (CONTRACTOR) reporting to the Executive Director, GCPQA. The role works closely with the Quality leadership and Study Execution Team members to provide ICH-GCP/GVP support for all ongoing clinical studies. This involves working closely with Clinical Operations, Clinical Development, Clinical Supply Chain, Data Management, Pharmacovigilance, Medical Affairs, Regulatory, Legal, and other teams across Alumis.

The Clinical QA Director is responsible to ensure quality is embedded throughout the lifecycle of all the ongoing clinical programs through oversight, assessment and monitoring, risk assessment tools, auditing and risk mitigations. The Director will assist with establishing Key Performance Indicators and Metrics to trend and track on the health of the clinical trials.

The role is responsible for providing the operational quality guidance for the development teams and supporting the Executive Director of GCP Quality in building the Alumis Quality organization strategy and vision.

This position requires expertise in Good Clinical and Pharmacovigilance Practices (ICH-GCP & GVP) and relevant US and EU regulations. The successful candidate will drive, promote, and embed a culture of ethics, integrity, and proactive quality management. The candidate will provide guidance and leadership to ensure that the quality function maintains the standards expected by global regulatory authorities.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Establish and maintain the ICH-GCP Clinical QA programs, policies, and procedures.
• Ensure ongoing clinical programs are in compliance with applicable health authority regulations, guidelines and internal Standard Operating Procedures.
• Act as the primary ICH-GCP Clinical QA subject matter expert and point of contact for all ICH-GCP/GVP related matters and issues for the assigned studies and initiatives.
• Establish/maintain the study specific audit plan; perform audits and lead a team of external quality auditors as needed.
• Represent Quality on project teams, Health Authority Inspections, service providers and CROs operational meetings, and Clinical QA to Clinical QA meetings.
• Provide quality oversight and review of key Clinical and IND/NDA enabling documents.
• Perform reviews of clinical trial documentation for data integrity and compliance with Good Clinical Practice guidance and regulations. Conduct root cause analysis for recurring issues.
• Support inspection readiness, plans and activities. Act as the primary liaison with Health Authority and internal/external business partners for the assigned studies and programs.
• Support clinical service provider selection and qualification activities and develop periodic compliance/metric reports.

EDUCATION & EXPERIENCE

• Bachelor’s or advanced degree in Biology, Chemistry, or related field.
• Minimum 10 years of ICH-GCP/GVP Quality Assurance experience.
• Experience with auditing (e.g. Investigator Sites, Clinical Trial Vendors, Processes)
• Strong understanding of small molecule products with direct experience in solid oral dosage forms.

KNOWLEDGE/ SKILLS/ ABILITIES

• Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices.
• Hands-on experience in drug life cycle management.
• A successful track record of working with service providers and CROs.
• Ability to make timely and sound quality decisions when faced with complex clinical, compliance, technical and regulatory considerations. Highly skilled in the ability to work with ambiguity and complexity.
• Knowledge of Quality Management Systems; experience in implementing and managing quality systems in the pharmaceutical industry.
• Excellent verbal and written communication skills.
• Collaborative, analytical and interpretative skills.
• Ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others. Prior management experience is required.
• Previous experience in successfully leading assigned activities within cross-functional teams.
• Approximately 15% travel required.

The salary range for this position is $193,000 USD to $242,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.

This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday. 

Alumis Inc. is an equal opportunity employer.

Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. 

Position Summary

Alumis is seeking an experienced Executive Medical Director or Senior Medical Director to lead clinical development strategy and execution for Phase 1 and Phase 2 studies evaluating envudeucitinib and A-005 across new indications identified for expansion of the Alumis pipeline. This high-impact role will be instrumental in shaping the company's clinical development portfolio, from indication selection through proof-of-concept studies, and will serve as a key scientific leader interfacing with internal teams, regulatory authorities, and the external medical community.

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Key Responsibilities

Clinical Development Strategy & Leadership

· Lead the design, planning, and execution of Phase 1 and Phase 2 clinical studies for A-005 and additional pipeline molecules in new therapeutic indications

· Develop and refine clinical development plans, including study synopses, protocols, and integrated development strategies for new indications

· Provide clinical and scientific leadership to cross-functional study teams, ensuring alignment on program goals, timelines, and deliverables

· Collaborate with Translational Medicine and Research teams to evaluate and prioritize new indication opportunities based on scientific rationale, competitive landscape, and unmet medical need

Study Execution & Oversight

· Serve as the Medical Monitor for assigned Phase 1 and 2 studies, ensuring patient safety and scientific integrity

· Oversee medical aspects of study conduct, including safety surveillance, protocol amendments, and data review

· Partner with Clinical Operations, Biostatistics, and Regulatory Affairs to ensure efficient study execution and high-quality data generation

· Lead interactions with Data Safety Monitoring Boards (DSMBs) and provide medical input for safety analyses

Regulatory & External Engagement

· Contribute to regulatory strategy and serve as a clinical representative in interactions with FDA and international regulatory authorities (EMA, PMDA, etc.)

· Prepare and review clinical sections of regulatory submissions, including IND amendments, briefing documents, and meeting packages

· Represent Alumis at scientific conferences, advisory boards, and with Key Opinion Leaders (KOLs) to advance clinical programs and gather external insights

· Build and maintain relationships with investigators, academic collaborators, and the broader medical community

Cross-Functional Collaboration

· Work closely with Translational Sciences, Biomarker, and Pharmacology teams to integrate biomarker strategies into clinical study designs

· Collaborate with Commercial and Medical Affairs teams on disease landscape assessments and indication prioritization

· Provide clinical expertise to support business development activities, including evaluation of potential partnerships or in-licensing opportunities

Team Development

· Mentor and develop junior medical staff, fostering a culture of scientific excellence and collaboration

· Contribute to building Alumis's clinical development capabilities as the organization grows

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Required Qualifications

· MD required; board certification or fellowship training in Rheumatology, Dermatology, or a related specialty strongly preferred

· 10+ years of pharmaceutical/biotechnology industry experience in clinical development, with a significant focus on immunology or autoimmune diseases

· Demonstrated experience leading Phase 1 and Phase 2 clinical studies from design through data readout

· Track record of successful regulatory interactions (FDA, EMA) and experience preparing IND/CTA submissions

· Deep understanding of early clinical development, including dose-finding strategies, biomarker integration, and adaptive trial designs

· Strong scientific acumen with the ability to critically evaluate preclinical and clinical data to inform development strategy

· Experience with JAK/TYK2 inhibitors or related immunomodulatory mechanisms preferred

· Excellent leadership, communication, and interpersonal skills with the ability to influence cross-functional teams in a matrixed environment

· Strategic mindset with demonstrated ability to balance scientific rigor with business objectives

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Preferred Qualifications

· Experience with indication expansion or lifecycle management for immunology assets

· Prior experience at a small or mid-sized biotechnology company; comfort operating in a fast-paced, resource-conscious environment

· Established relationships with KOLs in rheumatology, dermatology, or gastroenterology

· Experience with multiple autoimmune indications (e.g., psoriasis, psoriatic arthritis, lupus, atopic dermatitis, CNS inflammatory and degenerative diseases)

· Familiarity with regulatory pathways for expedited development (Breakthrough Therapy, Fast Track)

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Travel Requirements

Travel required (approximately 20-30%) to support investigator meetings, scientific conferences, regulatory interactions, and site visits.

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The salary range for this position is $300,000 USD to $400,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.

This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday. Remote candidates will be considered on a case-by-case basis.

Alumis Inc. is an equal opportunity employer.

Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.  

Other benefits include:

• Health insurance premiums paid at 90% for employee, 80% for dependents
• Free access to Genentech Bus & Ferry Share program
• $100 monthly cell phone stipend
• Unlimited PTO for Exempt employees
• Free onsite gym and a kitchen stocked with yummy snacks and drinks!

We are a hard-working, collaborative team on a mission to transform patient’s lives-- and we aspire to elevate, challenge and nurture one another along the way.

We have recently completed our pivotal trials of envudeucitinib, our second-generation tyk2 inhibitor in moderate to severe plaque psoriasis and expect results from a potentially pivotal Phase 2b trial in SLE in the third quarter of 2026.

As a key member of the Alumis team, you will provide overall leadership for the Medical Affairs function, overseeing Medical Affairs, Field Medical Liaisons, and publications. The position will liaise closely with the clinicians responsible for carrying out Alumis’ clinical studies as well as our commercial group. Applicants should be a “leader/doer” capable of generating strategies and leading cross functionally. This VP, Medical Affairs will report directly to the Chief Medical Officer. 

Responsibilities

Lead the Medical Affairs function at Alumis 

• Develop and implement key Medical Affairs strategies and activities to support the development of our lead assets 
• Continue to build and scale the Medical Affairs organization
• Develop and present Medical Affairs operational plans to Development and Executive management 
• Represent company externally 
• Direct and oversee all aspects of Medical Affairs and pre-launch needs
• Lead medical launch preparations for our lead Psoriasis candidate, ensuring the scientific narrative is robust and well-vetted.

As a member of the Development Leadership Team, run and continue to build the Medical Affairs function 

• Build and lead a best-in-class global medical affairs team to support launches of multiple indications with a focus on psoriasis for our lead asset, envudeucitinib   
• Develop key performance indicators and generate analytical reports related to Medical Affairs plans and Medical Science Liaison group activities 
• Develop and implement Medical Communication and Disease State Awareness strategies 
• Partner with KOLs to gather information on current focused therapeutic area issues and questions 
• Collaborate with the Commercial team to develop educational material for providers and patients that are balanced and medically accurate 
• Provide direction and input into the development and implementation of successful reimbursement and market-access strategies 
• Work closely with the members of the clinical development and commercial leadership teams to develop the overall strategic direction for Alumis, evaluate alternative strategies, identify competitive issues, and develop and implement operating plans to achieve company objectives 
• Foster collaborative relationships with academic and clinical experts, publishers, medical and patient associations, and other relevant external and internal stakeholders
• Develop and manage departmental budgets that effectively achieve desired goals and are balanced with the financial objectives of the broader organization 
• Oversee the publication strategy, ensuring clinical data is presented at major congresses (e.g., AAD, EADV, ACR) and in high-impact peer-reviewed journals.

Education | Experience | Skill Requirements

• 10+ years of professional experience within Biotech/Pharma in Medical Affairs  
• 5+ years of people leadership experience 
• An understanding of government and industry guidelines, regulations, laws, etc., for appropriate scientific/medical exchange and communication with customers 
• Ability to lead by example, attract and develop talent, build interdependent partnerships, and create a culture of collaboration and teamwork that fosters open communication, constructive conflict resolution and organizational flexibility 
• Ability to prioritize and manage several complex projects simultaneously 
• Proven ability to develop internal relationships in a highly matrixed environment, as well as external relationships with Key Opinion Leaders and industry experts 
• Ability to communicate effectively at all levels and present complex and/or new ideas with clarity and simplicity 
• Ability to prioritize concurrent projects with tight deadlines and operate in a highly compliance-driven environment 
• Excellent written, verbal, and interpersonal skills, and the ability to communicate at all levels within the company 
• Travel (25-40%) may be required to represent the company at medical conferences, presentations, and other meetings
• Our headquarters are located in the San Francisco Bay Area and regular presence at headquarters is required
• Extensive prior experience in dermatology, particularly psoriasis is required. Prior experience in SLE is highly desirable. Prior experience taking a product form Phase 3 to a successful launch is also highly desirable. 
• Advanced degree (PharmD, Ph.D. or MD) is required, MD is preferred.

The salary range for this position is $315,000 USD to $370,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.   

We are a team of clinical trial experts who are dedicated to the success of our clients so that patients can receive much-needed treatments. From the beginning, we have nurtured a culture where patients’ needs and the needs of our valued clients come first, where the quality of our work is the best, and where our employees can thrive while still having fun and giving back to the patient community. We are very proud of the Clinical Trial Management team at Precision for Medicine and what it has achieved thus far. Are you ready to be part of a close-knit clinical trial team that is passionate about saving and improving the lives of patients every single day? Then look no further, we’d like to help you take your career to the next level.

You will lead and manage the clinical team on a study in regards to timeline adherence and project scope while ensuring quality delivery. We encourage high-energy, dedicated professionals who enjoy a challenge, thrive in the details, and flourish in dynamic environments to explore this opportunity. If you are no stranger to taking charge and seek positive partnerships to deliver phenomenal work, we have an opportunity for you.

About You:

• You have a passion for bringing lifesaving and lifealtering treatments to market
• You love having responsibility and a say in how clinical trials are run
• You plan ahead but have alternative options in case things go wrong
• Last minute requests and shifting priorities don't rattle you
• You are extraordinary at handling study timelines while never sacrificing quality
• You communicate clearly, often, and concisely and know that your role is crucial in keeping the trial running smoothly
• You are a master at identifying any risks that threaten projects and handle them resolutely
• You thrive with minimal direction and happily take responsibility for the outcomes of your work
• You are a team player and thrive working in a collaborative environment

About the CTM Role:

• Management and operational delivery of the clinical elements within a trial, including site feasibility and selection, start-up, clinical plans and document development, subject enrollment, site engagement and support, monitoring planning and execution, resourcing, regulatory documentation, data cleaning activities, and close-out
• Successful execution of assigned trials and ensuring completion of trial deliverables
• Ensuring appropriate communication and ongoing oversight of assigned trial(s) by working in close collaboration with the sponsor and other functional team members
• Participation in and presentation at sponsor meetings, including bid defenses, kick-off meetings, investigator meetings, and face-to-face meetings
• Mentoring and training team members
• Identifying challenges to study timelines/deliverables and offering creative action plans to the team/sponsor
• Leading CRAs as they establish relationships with their sites for high quality oversight of monitoring, regulatory, IP, and overall site correspondence activities
• Contribute to company and department initiatives to grow and strengthen processes, procedures, and the PFM overall

Qualifications:

Minimum Required:

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field

• Clinical Trial Lead/Manager: Minimum of 5 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience.  Prefer at least 2 years of CTM experience at a CRO, Pharma or Biotech company.
• Senior Clinical Trial Lead/Manager: Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience.  Prefer at least 4 years of CTM experience at a CRO, Pharma or Biotech company.

Other Required:

• Moderate independent field monitoring experience
• Clinical team lead or comparable supervisory experience
• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
• Experience with various EDC and eTMF systems
• Excellent communication and interpersonal skills to effectively interface with others in a team setting
• Excellent organizational skills, attention to detail, and a customer service demeanor
• Availability for domestic and international travel, including overnight stays

Skills:

• Demonstrated computer skills (MS Office, M PowerPoint, etc.) and software experience (CTMS, eTMF, EDC, IXRS, RTSM, etc.)
• Demonstrated ability to develop positive working relationships with internal and external organizations
• Demonstrated core understanding of pertientent and various therapeutic areas, medical terminology, and clinical trial activities as it relates to the execution of a clinical development plan

Competencies:

Including, but not limited to:

• Demonstrates mastery knowledge of ICH-GCP, and regulatory guidance, as well as the ability to implement
• Working knowledge of clinical management techniques and tools
• Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency
• Results-oriented, accountable, motivated, and flexible
• Excellent time management, negotiation, critical thinking, decision making, analytical, and interpersonal skills
• Direct work experience in a cross-functional environment
• Excellent presentation, verbal, and written communications skills
• In-depth proven experience in pharmaceutical and/or device research required

The anticipated salary range for candidates who will work in South San Francisco, CA is $380,000 - $420,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.

We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. 

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.

About the Role >>> Lead Senior Medical Writer

As the Lead Senior Medical Writer, reporting to the Director of Medical Writing, you will lead the development, and delivery of high-quality scientific and regulatory documents supporting Olema’s oncology portfolio. This role requires strong cross-functional leadership, partnering closely with Clinical Science, Clinical Development, Regulatory Affairs, Biometrics, and other stakeholders to translate complex clinical and preclinical data into clear, accurate, and compelling content for regulatory submissions, medical communications, and scientific publications. In addition, you will drive consistency, quality, and timelines across deliverables, contributing to the overall medical writing strategy and supporting key regulatory and clinical milestones. 

This role is based out of our Boston, MA or San Francisco, CA office and will require 10-15% travel. 

Your work will primarily encompass: 

• Preparing and editing a wide range of scientific and medical writing deliverables, including but not limited to protocols, protocol amendments, clinical study protocols, investigator brochures, regulatory submission documents (e.g. IBs, DSURs, sections of IND/IMPD/MAAs), PowerPoint presentations related to the Medical Writing function
• Collaborating with internal stakeholders (clinical scientists, regulatory strategy, medical monitors, biometrics, medical affairs) to understand data, interpret results, and ensure accurate message conveyance
• Ensuring documents adhere to internal style guidelines, regulatory requirements (e.g., ICH, GPP), and appropriate therapeutic-area standards (e.g., oncology, breast cancer)
• Maintaining version control, track author/reviewer feedback, and delivering documents according to project timelines
• Providing  writing and/or QC editing support for associated submission documents (as applicable) to help elevate overall team deliverables
• Remaining current on therapeutic area (breast cancer / endocrine-driven tumors) trends, journal publications, and regulatory guidance relevant to oncology and women’s cancers

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor’s degree in life sciences, pharmacy, or related field; advanced degree (MS/PharmD/PhD) preferred
• Demonstrated and excellent scientific writing and editing skills — the ability to translate complex scientific data into clear, concise, accurate documents for varied audiences (regulatory agencies, KOLs, internal stakeholders)
• Familiarity with regulatory writing standards (e.g., ICH E3/E6, GPP)
• Oncology preferred 
• Veeva RIM experience is a plus 

Experience: 

• Minimum of 7+ years of medical or regulatory writing experience, oncology (especially breast cancer) preferred, or a closely related therapeutic area
• Strong project management skills: able to manage multiple deliverables, meet deadlines, handle feedback iterations, and coordinate with cross-functional teams
• Ability to work independently with minimal supervision, while also being a collaborative team player
• Detail-oriented, organized, with strong verbal communication skills
• Proficiency with standard technical and document-management tools (e.g., Microsoft Word, PowerPoint, Microsoft Excel, Smartsheet, Starting Point Templates, Veeva RIM)
• Prior experience in clinical-trial documentation for oncology (eg, IBs, protocols, DSUR and CSRs) preferred
• Experience working in hybrid/remote environments

Attributes: 

• Teamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others
• Self-motivated and enthusiastic; fast learner who can identify project challenges and expeditiously change course as required in a fast-paced organization
• Strong communicator who can tailor messaging to diverse audiences
• Highly organized with strong attention to detail and follow-through
• Ability in building strong cross functional working relationships 

The base pay range for this position is expected to be $160,000-$175,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

#LI-MT1

About the Role >>> Associate Director, Global Regulatory Strategy - International 

As Associate Director, Global Regulatory Strategy / International Regulatory Affairs, reporting to the Senior Director of Regulatory Affairs Strategy, you will contribute to the development and execution of regulatory strategies for Olema’s products in early to late-stage clinical development. You will represent Regulatory Affairs on cross-functional teams, lead the planning and preparation of clinical trial submissions (INDs, CTAs, amendments, briefing documents, Investigator Brochures) and support global health authority interactions.  

This role can be based out of our Boston, MA or San Francisco, CA office and will require domestic and international travel, approximately 10–15%

Your Work Will Primarily Encompass: 

• With limited supervision, support the development and execution of global regulatory strategies for products in Olema’s pipeline, with a focus on early development and clinical trial applications
• Serve as the Regulatory Affairs representative on global project teams and Study Execution Teams, providing regulatory input and ensuring alignment with program objectives and timelines
• Prepare and coordinate high-quality regulatory global submissions, including INDs, CTAs, amendments, annual reports, DSURs, Investigator Brochures, and briefing documents
• Under the supervision of the Senior Director, Regulatory Affairs, contribute to planning and execution of regulatory interactions with health authorities (e.g., FDA, EMA, Health Canada, MHRA), including meeting requests, briefing packages, and follow-up correspondence
• Monitor the global regulatory landscape to identify requirements, trends, and potential impact on Olema’s development programs
• Coordinate and maintain health authority reporting schedules in collaboration with cross-functional teams
• Partner with external vendors (e.g., CROs, regulatory consultants) to ensure high-quality and timely submissions
• Support development of Regulatory Affairs departmental policies, SOPs, and systems (e.g., Veeva) to enhance submission quality and efficiency
• Assist in risk assessment and mitigation planning for regulatory deliverables

Ideal Candidate Profile  

We are looking for a collaborative and driven Regulatory Affairs professional who thrives in a fast-paced environment and brings expertise in regulatory strategy

Knowledge: 

Bachelor’s degree in a scientific discipline required; advanced degree (MS, PharmD, PhD) preferred

Experience: 

• Minimum 10 years of related experience with a Bachelor’s degree; or 7 years and a Master’s degree; or a PhD with 5 years experience; regulatory affairs experience in the pharmaceutical or biotechnology industry
• Direct experience preparing and submitting clinical trial applications (INDs, CTAs) and managing regulatory authority correspondence 
• Knowledge of global regulatory requirements for clinical development (FDA, EMA, ICH guidelines)
• Oncology therapeutic area experience preferred
• Experience collaborating in cross-functional, matrixed teams 
• Experience working withCROs and other partners

Attributes: 

• Strong organizational, project management, and problem-solving skills
• Excellent oral, written, and presentation skills
• Flexible and proactive, with the ability to manage multiple projects and adapt to changing priorities
• Self-starter with the ability to work both independently and within teams

The base pay range for this position is expected to be $176,000 - $188,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

#LI-MK1

Company: 

At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and geographic atrophy, we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon, you’ll be part of a team committed to making an impact together.   

For more information on Annexon and our pipeline, check out our site Annexon Biosciences & Annexon Pipeline. We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane, CA. 

We're seeking exceptional talent from all backgrounds to fuel our growth. At Annexon, we're building a diverse, equitable, and inclusive workplace. We value unique perspectives and unconventional paths. If you're the best candidate for the job, even if you don't perfectly fit the traditional mold, we encourage you to apply. Learn more about our commitment to diversity, equity, inclusion, and our company culture! 

Position: 

We are seeking an accomplished and visionary leader to join our team as Vice President, Clinical Development-Neuroscience. The Vice President, Clinical Development-Neuroscience will serve as a key leader in driving the clinical strategy and execution of the portfolio of programs in neurodegeneration and neuro-immunologic diseases. This role will be responsible for the strategy for the investigation of clinical candidates in this therapeutic area and support the end-to-end design and execution of clinical programs, from Phase I through Phase III, ensuring scientific integrity, regulatory compliance, and alignment with corporate objectives. The successful candidate will collaborate with cross-functional teams, lead clinical aspects of regulatory submissions, and establish critical partnerships with key opinion leaders and external stakeholders to advance clinical initiatives. The ideal candidate will bring strategic vision, proven expertise and success in pharmaceutical development for drug candidates for neurologic diseases, clinical trial design and execution, and the ability to manage complex programs in a fast-paced environment. This individual will play a crucial role in translating innovative therapeutic concepts into real-world treatments, including collaborating with discovery research, translational medicine, regulatory affairs, pharmacovigilance, biometrics, clinical pharmacology, medical affairs and clinical operations, shaping the company’s success in the rapidly evolving field of neurology. 

Responsibilities include: 

• Lead the strategic direction and execution of the portfolio of neuroscience clinical development programs, from early-phase through late-stage ensuring they are scientifically robust and meet regulatory requirements
• Collaborate cross-functionally with teams in discovery research, translational medicine, regulatory affairs, pharmacovigilance, biometrics, clinical pharmacology, medical affairs and clinical operations to ensure the successful execution of clinical development plans
• Drive the preparation, submission, and management of regulatory filings, including clinical trial applications, investigator brochures, study protocols, and marketing authorization dossiers (e.g., BLA/NDA, MAA) ensuring alignment with global regulatory guidelines (e.g., FDA, EMA). 
• Analyze, interpret, and communicate data to inform key decisions, providing clear recommendations to guide clinical development strategy.   
• Establish and maintain strategic relationships with key opinion leaders (KOLs), clinical investigators, and external stakeholders to advance clinical initiatives.  
• Manage clinical trial budgets, timelines, and resources, ensuring the delivery of high-quality results aligned with corporate objectives.  
• Regularly present clinical progress, data outcomes, and strategic recommendations to executive leadership, stakeholders, and external partners.  
• Stay at the forefront of industry trends, scientific advancements, and regulatory developments to ensure the company remains competitive in the clinical development strategies.  
• Identify potential risks in clinical development timelines, budgets, or regulatory pathways, and develop contingency plans to mitigate them. 

Education, Experience, and Skills: 

Required: 

• MD or MD/PhD in with board certification in Neurology, Neuroscience, or a related field.  
• 15-20 years of experience in clinical development, with a focus on CNS-related indications.  
• Proven leadership in designing, managing, and executing clinical trials from early phase through late-stage development.  
• Demonstrated experience in leading clinical development teams at a senior or executive level, ideally within a high-growth biotech or pharmaceutical environment. 
• In-depth knowledge of global regulatory requirements and guidelines (e.g., FDA, EMA) and clinical development processes, including Experience in HA meetings, writing briefing books, attending/supporting meetings.  
• Exceptional leadership, strategic thinking, and communication skills with a proven ability to influence across functions and levels.   
• Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities.  
• Strong analytical and problem-solving skills, with a data driven approach to decision making.   
• Demonstrated success in building collaborations with cross-functional teams and external partners in a dynamic, fast paced environment.  

Preferred:  

• Experience with regulatory submissions and clinical trial oversight in a biotech or pharmaceutical setting. 
• Familiarity with emerging trends in neurology, including cutting-edge therapeutic modalities. 

Salary Range: $399,600 – $427,500 USD

Location: Annexon Biosciences is located in Brisbane, California and preference is given to candidates in the San Francisco Bay Area.

Benefits: 

• A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
• Shuttle service from BART, CalTrain and the Ferry.
• Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, and other benefits. 

Annexon Biosciences is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind.  We are committed to fostering an environment where ALL people are welcome and supported. We cultivate a culture of inclusion for all employees that respects their individual strengths, views, and experiences. We believe that our differences enable us to be a better team – one that makes better decisions, drives innovation, and delivers better business results. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect. 

The Opportunity

Step into a pivotal role where science meets strategy. At Maze, we’re on a mission to uncover genetic insights and transform them into precision medicines that change lives. Our team is driven by curiosity, collaboration, and a commitment to improving treatment for people with severe diseases. We thrive on diverse perspectives and bold ideas, and we’re looking for someone who shares that spirit.

As our Head of Quality, you’ll shape and lead the Quality function at Maze, guiding strategy, systems, and compliance across our development programs. You’ll be instrumental in evolving our GxP processes and ensuring we’re inspection ready as we move into Phase 2 and beyond, with a focus on robust vendor oversight and building scalable systems to support late-stage and future commercial success.

Reporting to the Vice President of Regulatory and Quality Science, you’ll manage and develop two direct reports and foster a culture of collaboration, accountability, and continuous learning that extends across the organization.

The Impact You’ll Have

• Be accountable for and evolve Maze’s GxP Quality strategy, providing leadership across internal operations and external partners, including CROs, CMOs, CTLs, and vendors supporting GxP activities
• Drive cross-functional integration of Quality across programs, ensuring timely engagement in key decisions
• Develop and implement risk-based Quality approaches for investigational materials, ensuring phase-appropriate systems from early development through commercialization, and proactively identify and mitigate quality risks
• Lead the development and continuous improvement of Quality Systems and SOPs supporting GxP activities
• Provide Quality oversight and input for regulatory submissions and correspondence, including INDs, IMPDs, CTAs, and interactions with FDA and global health authorities
• Provide Quality leadership for clinical programs, including oversight of CROs and clinical trial activities, ensuring GCP compliance and readiness for clinical inspections
• Partner strategically with CMC and lead GMP vendor oversight to ensure manufacturing, testing, packaging, labeling, and distribution activities comply with cGMP, FDA, ICH, EMA, and industry standards.
• Lead QA investigations, including product-impacting issues, and provide oversight and approval of CAPAs from deviations, complaints, recalls, audits, and inspections, ensuring timely and effective resolution and closure of findings
• Drive Maze’s inspection readiness and serve as the lead Quality representative during health authority inspections
• Represent QA on cross-functional teams and company initiatives, providing Quality leadership and guidance in decision-making
• Stay current on evolving global regulations and industry best practices related to GxP and compliance, and apply these insights to strengthen Maze’s Quality frameworks and systems
• Develop and deliver GxP training across Maze, identifying opportunities for continuous improvement and embedding industry best practices into daily operations
• Oversee Document Control systems, ensuring compliance, consistency, and effective lifecycle management of Quality records

As a Senior Director, we also you to demonstrate the following Leadership Competencies:

• Communication and Influence
  • Role models clear communication and open two-way conversations.
  • Reinforces an environment where people feel heard and their opinions are valued.
  • Inspires followership despite differing initial opinions.
• Teamwork and Collaboration
  • Champions collaborations and connections across Maze.
  • Establishes team norms and expectations.
  • Seeks opportunities to spotlight team and individual contributions in public forums.
• Execution and Results
  • Develops recommendations to seize on opportunities and mitigate obstacles that could impact long-term success.
  • Coaches others on resource management and work distribution/delegation.
  • Aligns work to Maze’s strategy, mission, and vision.
• Develop Others and Self
  • Develops staff capabilities to handle delegation of responsibilities.
  • Encourages staff to develop and execute personal stretch goals.
  • Identifies and recommends ways to increase inclusive leadership.

What We’re Looking For

• Bachelor’s degree in a scientific discipline with 12+ years of progressive experience in biotech or pharma GxP quality assurance and compliance
• Deep knowledge of global GxP regulations, including U.S. CFR, EMA, ICH, and other relevant standards
• Proven experience in building and refining QA related systems that support clinical and commercial development
• Strong understanding of GMP Quality across raw materials, drug substance, drug product, labeling, packaging, and distribution, including testing, stability, and retention
• Strong understanding of GCP Quality, including CRO oversight, clinical trial conduct, and inspection readiness
• Experience enabling release of investigational and commercial materials in compliance with regulatory requirements
• Skilled in GxP training and implementation, with a focus on practical adoption
• Track record of leading and supporting regulatory inspections, including FDA, EMA, and global agencies
• Experience drafting audit responses and implementing CAPAs
• Proficiency in root cause analysis and CAPA management
• Familiarity with eQMS and eTMF systems
• Experience managing and developing direct reports, with a focus on mentorship and professional growth
• Collaborative mindset, with experience working across internal teams and external partners
• Strong strategic and organizational skills, with the ability to prioritize multiple projects
• Excellent leadership and communication skills (written and oral)
• High ethical standards with a positive, proactive, and solution-oriented approach
• Willingness to travel domestically and internationally for inspections, vendor oversight, and industry events

This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least three days per week

About Maze Therapeutics

Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which allows it to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process it refers to as variant functionalization. The company’s pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease.  Maze is based in South San Francisco.

Our People

Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients.

Our Core Values

Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we’ll achieve our mission. 

Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others.

Stand True – Our integrity is foundational; it guides us no matter the obstacle.

The expected annual salary range for employees located in the San Francisco Bay Area is $257,000 - $314,000. Additionally, this position is eligible for an annual performance bonus. Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future.

Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy.

#LI-Hybrid

The Opportunity

Join us at Maze Therapeutics as our Director of Data Management, where you will play a key role in shaping the data strategy that supports our clinical development programs.  You’ll partner closely with Biostatistics, Statistical Programming, Clinical Operations, and Regulatory Affairs, and oversee external vendors to deliver high-quality, reliable clinical data across our studies.

Reporting to the Vice President of Biometrics, you’ll provide strategic direction and hands-on leadership for clinical data management activities spanning multiple clinical trials. Your work will ensure timely, compliant, and analysis-ready data that supports regulatory submissions and key program decisions.  

The Impact You’ll Have

• Lead data management activities across multiple clinical studies and development phases.
• Shape and implement data management strategies, standards, and best practices.
• Mentor and support data management team members, fostering growth and knowledge sharing.
• Serve as a subject matter expert for data management processes, systems, and regulatory expectations.
• Oversee critical study deliverables including DMPs, CRFs/eCRFs, edit checks, and database locks.
• Guide accurate, consistent, and timely clinical data collection, cleaning, and reconciliation.
• Review and approve key study documentation and ensure readiness for analysis and reporting.
• Drive database lock planning and partner closely with Biostatistics and Medical Writing to support analyses and study reports.
• Manage CROs and external vendors, ensuring clarity around timelines, quality expectations, and contractual commitments.
• Support the evaluation, implementation, and optimization of EDC and data management technologies.
• Collaborate closely with Clinical Operations, Biostatistics, and other partners across the organization.
• Provide data management insights for protocols, study design, and operational planning, while proactively communicating risks and mitigation strategies to senior leadership.

As a Director, we also expect you to demonstrate the following Leadership Competencies:

• Communication and Influence
  • Builds communication channels across Maze for sharing information.
  • Influences Senior Management decisions through persuasive arguments.
  • Respectfully addresses differing opinions leading to support of decisions.
• Teamwork and Collaboration
  • Champions partnerships and connections across Maze.
  • Proactively addresses issues that could result in breakdown of team relationships.
  • Spotlights team and individual contributions in public forums.
• Execution and Results
  • Addresses gaps and leverages strengths to get best results.
  • Maintains a steadying presence and clarifies priorities during change.
  • Anticipates and removes barriers that put functional/corporate goals at risk.
• Develop Others and Self
  • Remove barriers to staff development and empowers them to make their own decisions.
  • Stays current on industry trends and keeps direct-reports prepared and responsive.

What We’re Looking For

• Bachelor’s or advanced degree in Life Sciences, Computer Science, or related field 
• 8+ years of clinical data management experience in biotech, pharmaceutical, or CRO environments
• 3+ years of people and/or project leadership experience
• Hands-on experience with EDC systems (e.g., Medidata Rave, Oracle InForm)
• Strong understanding of clinical trial operations, data flows, and regulatory expectations
• Collaborative, mentorship-oriented leadership stylewith the ability to influence across teams

This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least three days per week.   

About Maze Therapeutics

Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which allows it to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process it refers to as variant functionalization. The company’s pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease.  Maze is based in South San Francisco.

Our People

Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients. 

Our Core Values

Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we’ll achieve our mission. 

Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others.

Stand True – Our integrity is foundational; it guides us no matter the obstacle.

The expected annual salary range for employees located in the San Francisco Bay Area is $232,000 - $284,000. Additionally, this position is eligible for an annual performance bonus.

Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future.

Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy.

#LI-Hybrid

The Position

As the Director, Biostatistics, you will play an important role in shaping and supporting the clinical development of Maze’s therapeutic programs. You will partner closely with Clinical Science, Regulatory Affairs, Clinical Pharmacology, Development Science, and Translational Science to ensure our clinical studies are robust, data-driven, and impactful.

In this role, you’ll oversee biostatistical strategy and execution, from study design through regulatory submissions, balancing hands-on expertise with strategic leadership. You will also represent Biostatistics on clinical study teams, guide interpretation of complex data, and oversee CRO partners to ensure high-quality statistical deliverables.

The position will report to the Vice President, Biometrics.

The Impact You’ll Have

• Serve as the biostatistics lead for clinical studies, providing expert input on study design, endpoints, and statistical strategy
• Oversee and contribute to completion of all technical and operational statistical activities for a group of clinical trials. Ensure development and review of statistical analysis plans (SAPs), including complex and innovative methodologies
• Collaborate with cross-functional partners in protocol development, study design discussions, and data interpretation
• Partner with Statistical Programming to generate and validate analyses for internal use, publications, and regulatory submissions
• Oversee CRO execution of statistical tasks: managing timelines, quality, and analytical approaches
• Represent biostatistics in regulatory interactions (FDA, EMA, PMDA, etc.), contributing to briefing documents, meeting preparation, and responses to agency questions
• Contribute to clinical study reports (CSRs), integrated summaries (ISS/ISE), and regulatory submissions (NDA/BLA/MAA)
• Apply advanced statistical techniques to explore, analyze, and interpret clinical, safety, biomarker, and exploratory data
• Advise internal and external partners on statistical approaches, data reliability, model selection, and interpretation of results
• Lead the gathering, organization and analysis of different data sources to enable delivery of special projects and / or the statistical analysis plan and clinical study endpoints for assigned products
• Review and analyze safety reporting, biomarker analyses and other aspects of clinical trial monitoring
• Develop enhancements to statistical software, as appropriate, by programming new techniques; maintain knowledge of current and emerging trends in statistical analysis methodologies and tools
• Provide biostatistical input into clinical development documentation, scientific publications and presentations, and regulatory documentation
• Adhere to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Maze SOPs
• Support due diligence, licensing, and partnering activities as needed

As a Director, we also expect you to demonstrate the following Leadership Competencies:

• Communication and Influence
  • Builds communication channels across Maze for sharing information.
  • Influences Senior Management decisions through persuasive arguments.
  • Respectfully addresses differing opinions leading to support of decisions.
• Teamwork and Collaboration
  • Champions partnerships and connections across Maze.
  • Proactively addresses issues that could result in breakdown of team relationships.
  • Spotlights team and individual contributions in public forums.
• Execution and Results
  • Addresses gaps and leverages strengths to get best results.
  • Maintains a steadying presence and clarifies priorities during change.
  • Anticipates and removes barriers that put functional/corporate goals at risk.
• Develop Others and Self
  • Remove barriers to staff development and empowers them to make their own decisions.
  • Stays current on industry trends and keeps direct-reports prepared and responsive.

What We’re Looking For

• An advanced degree in Biostatistics, Statistics, or a related field.
  • Master’s degree with 10+ years of experience, or Ph.D. with 8+ years of experience
• Comfortable being hands-on with analysis, simulations, and document review
• Direct experience designing early-stage trials (Phase I/II) and late-stage trials in resource-constrained settings
• Confident decision-maker who can influence at the executive level
• Collaborative, mentorship-oriented leadership style

This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least three days per week

About Maze Therapeutics

Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which allows it to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process it refers to as variant functionalization. The company’s pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease.  Maze is based in South San Francisco.

Our People

Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients. 

Our Core Values

Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we’ll achieve our mission. 

Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others.

Stand True – Our integrity is foundational; it guides us no matter the obstacle.

The expected annual salary range for employees located in the San Francisco Bay Area is $228,000 – $280,000. Additionally, this position is eligible for an annual performance bonus.

Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future.

Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy.

#LI-Hybrid

The Opportunity

At Maze Therapeutics, we believe that precision medicine has the power to transform the lives of patients with both common and rare diseases. As a Clinical Trial Manager (CTM) at Maze Therapeutics, you’ll play a hands-on role in co-leading and driving the execution of our Chronic Kidney Disease (CKD) clinical trials. You’ll have the opportunity to contribute to mid to late-stage clinical studies, work cross-functionally with internal teams and external partners, and ensure trials run efficiently and with the highest quality standards. If you enjoy rolling up your sleeves, collaborating across teams, and bringing innovative medicines to patients, this role could be the perfect fit for you. 

The Impact You’ll Have

• Steer the execution of one or more of our Phase 2 CKD clinical trials; from protocol development to achievement of corporate and study milestones such as first patient in, interim analysis, database lock, and study report completion. 
• Manage external vendors including CROs, additional key vendors, and global investigative sites. 
• Ensure adherence to study protocols, SOPs, ICH GCP guidelines by overseeing monitoring activities at investigative sites. 
• Coordinate the development of study materials such as CRFs, ICFs, patient diaries. 
• Act as the voice of Clinical Operations on cross-functional teams, including the Study Execution Team (SET). 
• Partner with Clinical Operations and Clinical Science Team to engage with therapeutic area KOLs and Investigators. 

What We’re Looking For

• A degree in a scientific discipline or health related field.
• Minimum of 4 years clinical research experience, including 2 years as a Clinical Trial Manager at a biopharmaceutical company or CRO.
• Experience with planning and executing Phase I-II trials is preferred. 
• Demonstrated proficiency in implementing, monitoring, and management of clinical trials, from start-up to close-out. 
• General knowledge of FDA regulatory requirements and ICH GCP guidelines. 
• Strong organizational skills, ability to prioritize and multi-task. 
• Excellent verbal and written communication skills. 
• Demonstrated problem-solving and negotiation abilities. 
• Ability to work as part of a team and build strong working relationships with internal and external partners.   
• Capacity to roll-up sleeves to perform a broad range of clinical trial related tasks as needed. 
• Willingness to travel as necessary, consistent with project needs. 
• Excellent computer proficiency (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook). 
• Experience with clinical trial databases (e.g., Medidata Rave, Veeva, etc.). 

About Maze Therapeutics

Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which allows it to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process it refers to as variant functionalization. The company’s pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease.  Maze is based in South San Francisco. 

Our People

Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients.  

Our Core Values

Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we’ll achieve our mission. 

Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others.

Stand True – Our integrity is foundational; it guides us no matter the obstacle.

The expected annual salary range for employees located in the San Francisco Bay Area is $143,000 - $175,000. Additionally, this position is eligible for an annual performance bonus.

Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future.

Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy.

#LI-Hybrid

About the Role >>> Senior Clinical Trial Associate 

As the Senior Clinical Trial Associate reporting to the Senior Manager, Clinical Trial Leader, you will provide comprehensive administrative and operational support to clinical team members across all study activities, including both in-house and outsourced trials. This role supports cross-functional study execution through coordination with internal teams, external vendors, and site staff, and may include contributing to study documentation such as informed consent forms (ICFs) and central IRB submissions, supporting site payments and other study-related operational activities, as well as liaising with and following up with investigator sites. Responsibilities include assisting with study start-up, maintenance, and closeout activities; managing study documentation and materials; supporting vendor management; and maintaining study trackers and financial records. This position adheres to Clinical Standard Operating Procedures and Good Clinical Practice (ICH) guidelines. 

This role is based out of either our office San Francisco or Cambridge office and will require approximately 10% travel. 

Your work will primarily encompass: 

• Supports the Clinical Trial Lead (CTL) and Study Execution Team (SET), ensuring ongoing accurate and essential documentation of study conduct 
• Manages study-related vendors and serves as a point of contact for contracted CROs, study staff, contract labs, and other study vendors 
• Acts as a key point of contact for investigator sites, facilitating communication, and ensuring effective coordination of study-related activities
• Conducts oversight of sample collection, shipment, and analyses 
• Conducts reconciliation and tracking of study processes in collaboration with study team and escalates issues in a timely fashion to study lead 
• Identifies potential risks and proactively resolves issues with CROs 
• Assists in the development of vendor management and other study plans and compiles study and quality metrics for CTL, management, and/or team review(s) 
• Facilitates flow and maintenance of correspondence with vendors and sites to provide or obtain study-specific information 
• Ensures receipt, completeness, accuracy, and appropriate filing (Trial Master File, study SharePoint, other study or Olema-specific systems) of clinical and administrative documents  
• Assists in coordination of study initiation documentation materials, including support for central IRB submission documents and review of site-specific informed consent forms. 
• Coordinates electronic distribution and/or shipment of study-related materials, as appropriate  
• Collaborates with relevant team members in the coordination and tracking of vendor and investigator site contracts, budgets, invoices, and/or payments as needed 
• Contributes to the development of the TMF plan and conducts periodic quality control reviews and records reconciliation of the Trial Master File (TMF)  
• Performs study and departmental administrative and clerical duties such as preparing agendas and minutes for team meetings and providing meeting planning and presentations 
• Actively participates in department initiatives and goals, providing suggestions that support the vision, mission, and enhancement of Clinical Operations; may lead certain SOPs or other processes

Ideal Candidate Profile >>>   

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge

• Bachelor’s degree is required 
• Familiarity with FDA/EMA regulatory requirements and ICH/GCP guidelines is preferred 
• Working knowledge of clinical protocols 

Experience

• Minimum of 3 years of related industry experience is required 
• Senior CTA requires 2 years' experience working as a Clinical Trial Associate. 
• Proficiency with Microsoft applications (e.g., Microsoft Word, Excel, PowerPoint, Outlook) 
• Experience with leading small group meetings and/or managing vendor relationships 

Attributes

• Highly motivated and enjoys working in a fast-paced, dynamic environment 
• Excellent teamwork and collaboration skills 
• Good organizational skills, ability to manage multiple tasks and meticulous attention to detail 
• Excellent written and verbal communication skills 
• Ability to accommodate a flexible work schedule according to clinical trial(s) priorities, as needed 

The base pay range for this position is expected to be $110,000 - $120,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-CK1

Company info

NewLimit is a biotechnology company working to radically extend human healthspan. We’re developing medicines to treat age-related diseases by reprogramming the epigenome, a new therapeutic mechanism to restore regenerative potential in aged and diseased cells. We leverage functional genomics, pooled perturbation screening, and artificial intelligence systems to unravel the biology of aging and disease using experiments of unprecedented scale.

Description

NewLimit is recruiting a VP of Clinical Development to plan and execute our first clinical trials. Our most advanced assets restore youthful hepatic metabolism and hold the potential to benefit diverse populations with liver disease and metabolic dysfunction. Our early stage programs have similar potential for impact in renal and inflammatory disease indications.

In this role, you will design and orchestrate clinical trials for some of the world’s first reprogramming medicines. You will serve as the company’s senior clinical scientist and as a member of our executive team.

As part of your role, you will:

• Lead and orchestrate clinical development activities in collaboration with external partners.
• Create clinical trial protocols, author and own regulatory submissions, and contribute to regulatory interactions.
• Solve the inevitable logistical bottlenecks that block progress of our clinical studies.
• Serve as a member of NewLimit’s Executive Team and contribute to budgeting, goal setting, and technical review decisions.
• Build and run a clinical development team as we approach first-in-human dosing.

Requirements

• M.D. or equivalent clinical training
• Experience planning and orchestrating first-in-human trials
• Experience with both US FDA and ex-US regulatory agencies (e.g. Australian TGA)
• Deep knowledge of Good Clinical Practices (GCP)

Nice to have

• Experience in metabolic and liver disease therapeutic areas
• Experience leading a clinical development team across multiple therapeutic areas
• Experience developing products in emerging therapeutic modalities (gene therapy, nucleic acid therapies, cell therapy)
• Experience managing both early (Phase 1/2) and late-stage (Phase 3) clinical trials

Benefits

• Health, dental, and vision insurance
• 401(k) with company match
• Industry-leading paid time off (PTO) -- 20 days/year for all employees + holidays
• Paid parental leave
• Meals and snacks on-site

Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Learn more at: https://www.newlimit.com/careers   

What You Will Contribute To Altos

As part of our team, you will help to accelerate and optimize our progress in agentic AI methods for biological and clinical data curation and analysis.

In this role, you will be an integral part of our multidisciplinary teams building the computational platforms that will enable Altos to achieve its mission. You will collaborate with biomedical research experts as well as other machine learning scientists and engineers across the Institute of Computation to contribute to the Altos research and translation ecosystem, focusing on designing and building state-of-the-art agentic AI systems and workflows that tackle biological questions, accelerate clinical data analysis, and aid in the discovery of novel interventions for aging and disease.

The successful candidate will combine deep expertise in agentic AI methods with a strong foundation in bioinformatics and/or clinical R&D. You will work closely with domain experts to translate complex biological and clinical data challenges into intelligent, automated solutions. You will thrive in a fast-paced environment that stresses teamwork, transparency, scientific excellence, originality, and integrity.

Responsibilities

• Design and develop agentic AI workflows for biological and clinical data curation tasks
• Research and implement advanced context engineering techniques (RAG, agentic RAG, graph RAG) tailored to biomedical data
• Develop and optimize prompts and agent architectures for reliability, accuracy, and scientific rigor
• Build LLM-based tool-use systems and integrations relevant to bioinformatics and clinical R&D pipelines
• Collaborate with bioinformatics scientists, clinical researchers, and domain experts to identify automation opportunities and translate them into agentic solutions
• Evaluate and benchmark agentic systems, establishing rigorous metrics for performance and correctness in scientific contexts
• Stay current with the rapidly evolving landscape of agentic AI methods and contribute to internal best practices

Who You Are 

• Proven track record leveraging machine learning and AI to solve real-world problems
• Expertise in agentic AI methods development, including prompt optimization, LLM-based tool use, context engineering (RAG, agentic RAG, graph RAG), and agent evaluation
• Experience writing production-quality code with agentic frameworks (e.g., LangGraph, Pydantic-AI, DSPy, or similar)
• Deep familiarity with bioinformatics and/or clinical R&D, with the ability to engage meaningfully with domain experts on biological and clinical questions
• Proficiency with AI-assisted development tools (e.g., Claude Code, Cursor) to iterate rapidly
• A team player who thrives in collaborative environments and is committed to enabling colleagues to reach their full potential through giving and requesting feedback focused on professional growth
• Able to advise others across the wider function / company on cutting edge agentic AI practices and approaches to enable the science / research. Desire to constantly expand your skillset and knowledge. Keen to learn more about biology, machine learning, and medicine
• Inspired by the Altos mission of restoring cell health and resilience to reverse disease, injury, and age-related disabilities

Minimum Qualifications

• PhD in Computer Science, Machine Learning, Bioinformatics, or a related field
• Demonstrated experience developing agentic AI systems, including LLM-based tool use, prompt engineering, and context engineering techniques
• Strong foundation in machine learning principles and their application to real-world problems
• Strong background in bioinformatics, computational biology, or clinical R&D
• Familiarity with MCP server development and agent skill creation
• Very strong programming skills in Python, with experience writing production-quality, well-documented code
• Strong track record of published peer-reviewed research in AI/ML and/or computational biology

Preferred Qualifications

• Experience with AWS services (S3, Bedrock, Lambda) in the context of AI/ML workflows
• Experience with clinical trial data, regulatory data curation, or biomedical ontologies (e.g., CDISC, SNOMED, MedDRA)
• Track record working with NGS data (e.g., RNA-seq, ATAC-seq, DNA methylation) or other biological data modalities
• Experience designing evaluation frameworks and benchmarks for agentic AI systems
• Familiarity with knowledge graph construction and graph-based retrieval methods

The salary range for Redwood City:

• Senior Scientist I, Machine Learning: $257,400 - $330,000

The salary range for San Diego:

• Senior Scientist I, Machine Learning: $239,500 - $307,000

Exact compensation may vary based on skills, experience, and location.

#LI-NN1

For UK applicants, before submitting your application:

- Please click here to read the Altos Labs EU and UK Applicant Privacy Notice (bit.ly/eu_uk_privacy_notice)
- This Privacy Notice is not a contract, express or implied and it does not set terms or conditions of employment.

The role:

The Clinical Trial Manager (CTM) is a key member of the Clinical Operations team and will report into the Associate Director, Clinical Operations, partnering closely on the start-up and initiation of a global Phase 3 program. The primary responsibility of the CTM will be regional study management and vendor management.

Key responsibilities:

• With guidance from the Associate Director, ClinOps, responsibility for day-to-day activities within a region or regions, including site selection, start-up, maintenance, and close-out activities. With guidance, may serve as the key operational contact for Braveheart Bio studies aiding in site selection, study implementation, and ongoing coordination of study sites, either directly or via CROs.
• Assist Associate Director, ClinOps with oversight of CRO and set-up of vendors as required, including liaising with Global CRO to ensure timely initiation of study.
• Day-to-day contact with counterparts at CRO and/or trial sites, including daily review and identification of potential issues or problems that must be communicated/escalated directly to Associate Director, ClinOps.
• Review site Informed Consent Forms and escalate to appropriate individuals, as needed. Assist with regulatory submission package review for submissions within region.
• Proactively identify potential operational challenges and, in collaboration with senior team members, provide solutions to ensure study execution remains on track.
• Perform accompanied visits (PSSVs, SIVs, RMVs) with CRO CRAs to ensure study procedure conduct is in accordance with SOPs and protocol procedures, and review routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
• With guidance, may assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports. May assist in compilation of investigator brochure appendices under close supervision.
• Review of trip reports generated by CRO CRAs for trends and quality issues.
• Review protocol deviations and monitor for trends.
• Coordinate review of data listings and preparation of interim/final clinical study reports, including resolving data discrepancies.
• Provide regular study updates to the appropriate internal stakeholders.
• Maintain internal Clinical Operations databases and document repositories.
• Perform administrative duties in a timely manner as assigned.
• Guide and support junior team members, ensuring alignment on deliverables, timelines, and quality standards.

Required experience & skills:

• At least 4+ years of relevant experience with a BS or BA in a relevant scientific discipline or an RN (2- or 3-year certificate)
• Relevant clinical trial experience in the pharmaceutical or biotechnology industry 
• Experience as the regional lead for Europe, United States, Latin America, and/or APAC
• Excellent attention to detail, interpersonal and presentation skills are a critical asset
• Excellent organizational, problem-solving and time management skills
• Must be familiar with routine medical/scientific terminology
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable
• Must be familiar with Word, PowerPoint, and Excel (intermediate or higher excel proficiency a plus)
• Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision
• High energy level, personal productivity, creativity and commitment
• Highly adaptable team-player
• Strong written and verbal communication skills with a collaborative, team-oriented approach
• Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
• Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude
• This position is for remote work and may require domestic or international travel up to 25% (as needed); valid travel documents must be obtainable.

Salary Range: $140,000 - $170,000

Company: 

At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and geographic atrophy, we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon, you’ll be part of a team committed to making an impact together.   

For more information on Annexon and our pipeline, check out our site Annexon Biosciences & Annexon Pipeline. We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane, CA. 

We're seeking exceptional talent from all backgrounds to fuel our growth. At Annexon, we're building a diverse, equitable, and inclusive workplace. We value unique perspectives and unconventional paths. If you're the best candidate for the job, even if you don't perfectly fit the traditional mold, we encourage you to apply. Learn more about our commitment to diversity, equity, inclusion, and our company culture! 

Position: 

The Associate Director of Clinical Trial Management will contribute to the development and implementation of clinical studies. Responsibilities include providing leadership to staff and study teams to ensure clinical trials are conducted in accordance with the protocols, Standard Operations Procedures (SOPs), Good Clinical Practices (GCPs), and other applicable regulatory requirements. Establish and lead meetings with CROs and other trial vendors and serve as a key escalation point for teams and vendors. The Associate Director will contribute Clinical Operations expertise in cross-functional meetings and develop and implement department initiatives. Management and mentoring of direct reports (Manager through entry level) is expected.  This position reports into the Executive Director or VP of Development Operations. 

Responsibilities include: 

• Accountable for the oversight and execution of multiple clinical trials including: 
• Develop, implement, and provide oversight of vendor budgets and contracts 
• Tracking and reporting of study metrics 
• Identify and mitigate risks to study implementation, enrollment, conduct, compliance, and completion 
• Develop and manage effective working relationships with Investigators and other key clinical opinion leaders 
• Provides technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct 
• Remains current with therapeutic areas under study, industry practices / trends and FDA requirements. Applies this knowledge to current programs
• Partners with and maintains regular contact with key stakeholders including Regulatory, Clinical Development, Legal, Finance, and others as necessary 
• Leads the team in the selection of Contract Research Organizations (CROs) for both large budget and small budget 
• Attends CRO or other vendor meetings such as project kick-off and investigator meetings, quarterly face-to-face meetings, and others as necessary to assure alignment and achievement of study goals 
• Contributes to definition, development, and implementation of Clinical Operations functional initiatives for role clarity and institution of best practices 
• Travel may be required up to 30% in support of clinical study activities

Education, Experience, and Skills: 

Required: 

•  BS/BA degree in related discipline or equivalent combination of education and experience
• 10+ years of experience leading clinical trial operations including multinational/multisite clinical studies with experience in ophthalmology, neurology,  rare diseases, and overall drug development. Strong leadership skills with ability to be hands-on and lead/ manage the clinical team. Experience with direct line-management of clinical operations staff.
• Has a thorough knowledge of the clinical development process, FDA, EMA and other regulatory requirements that may impact global clinical studies as well as ICH and GCP guidelines
• Has demonstrated success identifying, negotiating and overseeing outsourced clinical operations services and vendors
• Experience with financial budgeting or reporting
• Ability to interact with investigators, vendors, and individuals at all levels of the organization 

Salary Range: $179,000 - $200,000 

Location: Annexon Biosciences is located in Brisbane, California and preference is given to candidates in the San Francisco Bay Area. 

Benefits: 

• A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
• Shuttle service from BART, CalTrain and the Ferry.
• Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, and other benefits. 

Annexon Biosciences is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind.  We are committed to fostering an environment where ALL people are welcome and supported. We cultivate a culture of inclusion for all employees that respects their individual strengths, views, and experiences. We believe that our differences enable us to be a better team – one that makes better decisions, drives innovation, and delivers better business results. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.