The Enterprise Account Executive (Healthcare & Life Sciences) will report to the Director of Enterprise GTM and own revenue growth across a portfolio of Scale AI’s most strategic healthcare and life sciences customers. This role is focused on selling complex, agentic AI solutions - autonomous workflows powered by LLMs and human-in-the-loop systems - into health systems, payers, pharma, biotech, and digital health organizations.

You will act as a strategic partner to clinical, operational, and technical leaders - helping them transform core workflows such as clinical documentation, prior authorization, revenue cycle, pharmacovigilance, clinical trials, medical affairs, and patient engagement through AI agents. This is a highly consultative, technical enterprise sales role requiring deep domain fluency, strong executive presence, and the ability to navigate regulatory, compliance, and multi-stakeholder complexity.

You will own the full customer lifecycle - from origination through close, deployment, and expansion - while quarterbacking cross-functional teams across Solutions Engineering, Product, Research, and Delivery to land and scale high-impact AI programs.

You Will:

• Own and expand relationships with leading healthcare and life sciences organizations (providers, payers, pharma, biotech), focusing on multi-year, strategic AI initiatives
• Sell agentic AI solutions by mapping Scale’s capabilities to high-impact workflows (e.g., clinical documentation, prior auth, revenue cycle, patient ops, clinical trials, drug safety, medical review)
• Build trusted relationships with executive stakeholders (CIO, CTO, CMIO, Chief Data/AI Officer, Heads of Clinical Ops, R&D, Commercial)
• Develop and execute multi-threaded account strategies that drive net-new revenue, expansion, and long-term platform adoption
• Lead complex deal cycles, including ROI modeling, business case development, and mutual close plans across new business, renewals, and expansions
• Partner closely with Solutions Engineering to design and land technically credible pilots, POVs, and production deployments
• Navigate healthcare-specific regulatory and compliance requirements (e.g., HIPAA, GxP, data governance, auditability) throughout the sales process
• Act as the voice of the customer internally - informing product roadmap, agent design, and vertical-specific solutions
• Maintain strong pipeline discipline, forecasting accuracy, and deal hygiene using Salesforce, Clari, and related tools
• Operate effectively in a fast-paced, cross-functional environment with high ownership and attention to detail

Ideally, You Will Have:

• 8–12+ years of enterprise sales experience, with significant focus on healthcare or life sciences (providers, payers, pharma, biotech, or digital health)
• Proven track record of closing and expanding large, complex, multi-million dollar deals in regulated environments
• Experience selling AI/ML, data platforms, or workflow automation technologies, with the ability to position agentic / LLM-driven solutions to both technical and non-technical stakeholders
• Strong understanding of key healthcare/life sciences workflows (e.g., clinical operations, revenue cycle, patient engagement, R&D, clinical trials, pharmacovigilance)
• Demonstrated success engaging executive stakeholders and building compelling ROI-driven business cases
• Familiarity with regulatory and compliance considerations (e.g., HIPAA, FDA/GxP, data privacy, model governance)
• Strong command of enterprise sales fundamentals, including account planning, multi-threading, and forecasting discipline
• Ability to navigate long, complex sales cycles with multiple stakeholders and competing priorities
• Excellent communication, storytelling, and executive presence
• High degree of ownership, intellectual curiosity, and a consultative, customer-first mindset

Nice to Haves:

• Experience selling agentic AI, LLM platforms, or automation solutions into healthcare or life sciences
• Background working with clinical, regulatory, or data organizations
• Familiarity with EHR systems, clinical data, or real-world evidence platforms
• Experience in high-growth or emerging technology environments

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

Company Overview

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 20+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.

Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.

To learn more about our story and company culture, visit us at bridgebio.com.

What You’ll Do

The Director / Senior Director, Quality Assurance is responsible for managing and overseeing the Good Pharmacovigilance Practices (GVP) quality and compliance program at Eidos Therapeutics and other assigned BridgeBio affiliate companies. It requires strong judgement skills and business acumen in order to advise internal and external key stakeholders on interpretation and compliance with FDA, EMA, MHRA and international pharmacovigilance (PV) regulations/guidelines; corporate policies; and standard operating procedures (SOPs). This individual will be a lead point of contact in the preparation and management of GVP regulatory inspection activities.

 Responsibilities

• Provide strategic and operational guidance to the organization, including, drug safety/pharmacovigilance, medical affairs, regulatory, commercial, clinical operations and outsourcing functions, to align with company procedures, regulatory requirements and best practice

• Support the internal and external GVP audit program

  • Oversee audit schedule and the execution of the audit program

  • Lead or co-lead auditor on PV audits as needed

  • Review and/or approval of audit reports and corrective and preventive action (CAPA) responses

• Maintain and contribute of audit and quality data for the Pharmacovigilance System Master File (PSMF)

• Core GVP regulatory inspection team member

  • Lead or participate in inspection readiness activities

  • Host or support of regulatory inspections

  • Perform quality review of inspection requests

  • Oversee the development and tracking of regulatory responses/commitments

• Review of Quality Agreements and PV/Safety Data Exchange Agreements (PVA/SDEA) to assess quality standards and regulatory compliance requirements

• Participate in the investigation and assessment of PV/GxP-related quality events and provide input on proposed CAPAs

• Develop, generate and present PV quality/compliance metrics for trending and process improvement

• Provide quality oversight on PV-related computer system validation projects and maintenance of systems

• Collaborate with Eidos and BridgeBio affiliate companies to develop and continuously improve processes and systems, including policies, SOPs and training plans

• Partner cross-functionally to support the business with compliance or quality issues/concerns by ensuring appropriate evaluation, mitigation and escalation to Executive Management

• Keep abreast of changes in regulations and enforcement actions and make recommendations for changes to policies and practices as needed

Where You’ll Work 

This is a hybrid role and will require in-office collaboration in our San Francisco Office. 

Who You Are

• Bachelor’s degree with 10-15+ years of GVP quality and compliance experience within a biopharmaceutical company, or contract research organization

• Current knowledge of global GVP regulations and guidelines – US Code of Federal Regulations, EMA, MHRA, and ICH Guidelines

• Ability to engage in cross-functional interactions with internal and external staff

• Has a comprehensive understanding of current approaches in industry and the ability to incorporate them into Eidos and BridgeBio affiliate programs

• Applies strong analytical and business communication skills

About the Role >>> Vice President, Quality Assurance  

The Vice President, Quality Assurance serves as the senior leader accountable for defining and driving Olema’s global quality strategy, systems, and governance across the full product lifecycle, including clinical development, manufacturing, pharmacovigilance, and commercial. This leader is the primary voice of Quality at the executive level and ensures a phase-appropriate, risk-based approach to quality that reflects the needs of oncology drug development, where patient safety, data integrity, and speed are critical.  

Operating with appropriate independence, this role partners cross-functionally and leads an established Quality leadership team across GCP, GMP, and GPV - aligning priorities, strengthening execution, and ensuring inspection readiness as Olema advances toward late-stage development.

This role is based out of our either our San Francisco, CA or Boston, MA office and will require some travel as needed.  

As Vice President, Quality Assurance, your work will primarily encompass:

Quality Strategy & Leadership  

• Define and drive a pragmatic, phase-appropriate and unified Quality strategy aligned with Olema’s pipeline and corporate objectives   
• Serve as the senior Quality leader, establishing clear governance, decision-making frameworks, and escalation pathways   
• Lead and develop Quality leadership across GCP, GMP, and GPV, enabling strong execution and maintaining clear accountability   
• Foster a culture of quality, integrity, and patient focus across the organization   
• Act as escalation point for significant quality, compliance, and patient safety risks   
• Ensure ongoing inspection readiness across clinical, manufacturing, and safety domains 

Quality Systems & Governance  

• Set expectations and direction for a scalable, integrated, and sustainable Quality Management framework spanning clinical through commercial stages   
• Ensure effectiveness and evolution of Quality systems through oversight of functional leaders across the QA function   
• Drive consistency in quality processes, risk management approaches, and data integrity standards across the organization   
• Establish clear quality metrics and reporting to enable risk visibility and informed decision-making 

Clinical Quality (GCP)  

• Ensure Quality approaches appropriately support the execution of oncology clinical trials   
• Provide oversight of clinical quality and CRO management to ensure patient safety and data integrity   
• Partner with Clinical and Regulatory to support inspection-ready programs and submissions

Manufacturing & Commercial Readiness (GMP)  

• Ensure Quality strategy supports manufacturing scale-up and readiness for late-stage development and commercialization   
• Oversee GMP Quality through established leadership, ensuring appropriate CMO/CDMO oversight and inspection preparedness   
• Provide Quality input into CMC, validation, and supply chain readiness activities

Pharmacovigilance Quality (GPV)  

• Oversee the pharmacovigilance quality framework, ensuring compliance, data integrity, and effective safety surveillance   
• Ensure PV systems and vendors are appropriately governed and inspection-ready   
• Partner cross-functionally to support ongoing evaluation of benefit-risk

Inspection, Audit & Risk Management  

• Lead the Company’s approach to regulatory inspections, including preparation and execution   
• Ensure risk-based audit programs across GCP, GMP, and GPV   
• Drive proactive identification and mitigation of quality and compliance risks

Cross-Functional Leadership  

• Partner with Executive Leadership, Regulatory, Clinical, and Manufacturing, to embed quality across the organization   
• Provide clear, actionable Quality perspectives to support business decisions   
• Represent Quality in executive discussions and external engagements as needed   

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

• Advanced degree in Life Sciences or related discipline (PhD, PharmD, MS) 
• Deep knowledge of FDA, EMA, ICH, and global GxP and pharmacovigilance (GPV) regulatory requirement 
• Expertise across GCP, GMP, and GPV Quality domains 
• Strong understanding of Quality systems, governance, and inspection readiness practices 
• Working knowledge of oncology drug development

Experience

• Minimum of 15+ years of Quality experience in biotech/pharma with increasing scope and responsibility 
• Significant people management and leadership experience, including leading senior team members 
• Experience overseeing global vendor networks, including CROs, CMOs, CDMOs, and PV vendors 
• Demonstrated experience across GCP, GMP, and GPV environments 
• Proven track record supporting programs from clinical development through late-stage or commercial readiness 
• Experience leading regulatory inspections and interacting with global health authorities 
• Experience implementing and maintaining Quality systems and compliance frameworks

Attributes

• Strong leadership capability with ability to lead through and develop senior leaders 
• Effective communicator with executive presence and influencing skills 
• Sound judgment and decision-making in complex, risk-based environments 
• Ability to operate effectively in a fast-paced, evolving biotech environment 
• Commitment to quality, compliance, and patient safety 

The base pay range for this position is expected to be $315,000 - $340,000 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-AD1

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.

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.

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 Position

The Clinical Development team is seeking a Senior Director, Safety Science to establish, lead, and scale safety science and pharmacovigilance (PV) at Maze. This role will serve as Maze’s first internal Safety Science leader, with responsibility to build the safety function from the ground up while providing enterprise-level leadership across the clinical portfolio. 

In this highly visible and hands-on leadership role, you will define and own the safety strategy across our clinical programs, spanning both common and rare diseases in nephrology and cardiometabolic indications.   

You will have end-to-end responsibility for safety surveillance, adverse event reporting, risk management, and PV governance, while partnering closely with Clinical Development, Regulatory, Biostatistics, and Clinical Operations. As Maze advances programs from early to late-stage development, you will play a critical role in shaping safety strategy, influencing decision-making, and ensuring patient safety remains central to our work. 

This position reports to the Head of Clinical Development. 

The Impact You’ll Have

In this role, you will combine deep safety scientific expertise with senior-level leadership and a willingness to operate in both strategic and executional modes. 

• Safety Strategy & Oversight 
  • Lead and build Maze’s safety science and PV function, scaling the strategy, activities, and team to support the development lifecycle from early clinical development through late-stage studies and regulatory submissions 
  • Serve as the primary internal owner of safety science and PV activities, directly overseeing day-to-day safety operations while establishing future-state processes and capabilities 
  • Lead safety surveillance and signal identification activities, proactively identifying risks and developing mitigation strategies 
  • Provide strategic and operational oversight for case processing, adverse event reporting, and regulatory compliance 
  • Oversee the preparation, review, and submission of aggregate safety reports and safety sections of clinical and regulatory documents 
  • Author and maintain safety-related content for clinical and regulatory documents, while establishing scalable content standards and governance for future team expansion. 
  • Guide benefit-risk assessments and safety-related recommendations that inform program progression and development decisions 
• Leadership & Collaboration 
  • Establish Maze’s Safety Science and PV function, defining vision, operating model and fostering a culture of accountability, development, and scientific rigor 
  • Partner cross-functionally to develop and execute Safety Management plans aligned with program and corporate objectives 
  • Serve as a subject matter expert in internal governance forums and external discussions with KOLs, advisors, and health authorities. 
  • Influence senior stakeholders across functions to align on safety strategy, risk tolerance, and development trade-offs 
• Operational Excellence 
  • Oversee and directly engage in operational PV activities as needed, including close collaboration with external consultants supporting case processing and compliance 
  • Design and evolve a scalable PV operating model that transitions from external support to internal ownership over time 
  • Provide strategic direction for outsourced PV activities, including CROs, consultants, and vendors 
  • Anticipate operational or compliance risks and proactively implement solutions that protect patients and enable program success  

As a Senior Director, we also expect 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

• Advanced degree in health sciences (MD/DO, PharmD, PhD) with 7+ years of experience in pharmacovigilance and drug safety, including hands-on operational leadership and strategic oversight of late-stage clinical programs and/or regulatory submissions 
• Demonstrated experience building or standing up safety science or PV capabilities in a resource-constrained or high-growth environment 
• Deep and current knowledge of global pharmacovigilance regulations, safety requirements, and evolving regulatory expectations. 
• Experience with medical review of individual case reports (ICSRs), signal detection, cumulative safety assessments, and risk management planning 
• Proven ability to move fluidly between strategic leadership and detailed execution, particularly in early-stage of first-in-function roles 
• Track record of influencing development, regulatory, and portfolio decisions at senior and governance levels 
• Experience managing and transitioning work from external consultants and vendors to internal teams 
• A collaborative, ethical, and inclusive leadership style with the ability to inspire followership and alignment across functions  
• Ability to travel domestically up to 10-15% for internal and external meetings 

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 base salary range for employees located in the San Francisco Bay Area is determined by credentials and qualifications: 

• Non-MD candidates: $288,000 – $352,000 

• MD candidates: $342,000 – $418,000 

The MD salary range reflects additional medical training and responsibilities associated with medical review, safety signal evaluation, and safety governance. 

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

Role Overview 

The Executive Director, Clinical Quality Assurance (CQA) will be responsible for all aspects of Quality Assurance focused on Good Clinical Practice (GCP), Good Pharmacovigilance Practices (GPvP) and Good Laboratory Practices (GLP) activities to ensure quality assurance and compliance of Jade sponsored clinical trials with applicable regulations, ICH guidelines, OECD Principles of GLP, Jade procedures and policies, and current industry standards and practices.

The Executive Director, Clinical Quality Assurance will perform day-to-day clinical quality operations and compliance activities to support the success of our clinical programs in addition to being a strategic partner to Clinical Development and Operations. This role will maintain and ensure effectiveness of quality programs and documentation to assure compliance and inspection readiness with all applicable quality requirements and regulatory standards. The ideal candidate brings hands-on expertise in GCP, GPvP and GLP QA operations, a proactive approach to problem-solving, and the ability to guide and influence cross-functional teams while upholding the highest standards of quality and compliance.

Key Responsibilities

• Provide hands on clinical QA oversight and review of protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other clinical trial specific documents.
• Provide coaching, Quality decisions and be Quality approver to study teams on protocol deviations, vendor oversight, CAPAs, and issue management.
• Act as the primary GCP/GPvP/GLP QA subject matter expert and point of contact for all related matters and issues.
• Represent Quality on project teams, service providers and CROs operational meetings, and QA to QA meetings.
• Oversee ongoing clinical programs to ensure they are risk‑based, fit‑for‑purpose and in compliance with applicable regulations and guidelines across all phases of development.
• Review and approve (as appropriate) procedures, service provider quality agreements, qualification and onboarding forms and regulatory filings.
• Develop, implement and execute a risk-based audit strategy and detailed plans for clinical and non-clinical studies.
• Establish and maintain GCP/GPvP/GLP QA programs, policies and procedures.
• Work collaboratively with the internal Clinical Operations Team and Development Teams to provide leadership and guidance to support study execution, data integrity, and regulatory compliance.
• Identify and assess compliance risk and develop and implement risk mitigation measures.Lead the identification, investigation (root cause analysis), and resolution of quality issues through a robust investigation and CAPA process.
• Contribute to building a strong quality culture within the organization.
• Ensure the timely and effective follow up of all identified or assigned quality issues.
• Direct and/or deliver yearly training for internal staff as needed.
• Work closely with Development, Clinical Operations, and other functions/departments to drive inspection readiness and support regulatory interactions.
• Champion continuous improvement and simplification across clinical quality systems.
• Prepare KPIs, metrics and analysis and present status updates as needed.
• Provide leadership in inspection preparedness to clinical sites and service providers for regulatory government agencies.
• Stay current on global regulations, industry trends, and best practices to ensure continuous improvement and innovation within the QA function.
• Apply risk‑based thinking to identify the quality activities that meaningfully influence study outcomes, rather than defaulting to checklists or bureaucracy.
• Understand when to escalate, when to intervene, and when to let teams move forward without over engineering processes.
• Provide clear, concise guidance that helps teams stay focused, aligned, and inspection ready.

Qualifications 

• Bachelors + 17 or Masters + 15 or PhD + 10 years of related experience Extensive expertise in GCP, GPvP, GLP and ICH clinical requirements, clinical development and methodologies of clinical studies.
• Successful track record of translation and implementation of clinical requirements into operational execution.
• Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices.
• 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.
• Ability to tactically and strategically execute the day-to-day operations to support clinical trials and clinical and non-clinical development activities. 
• Knowledge of Quality Management Systems; experience in building, implementing and managing quality systems in the pharmaceutical industry.
• Expertise in reviewing, revising, and writing Standard Operating Procedures (SOPs).
• Effective communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies.
• Strong organizational skills and the ability to participate effectively cross-functionally.
• A self-starter and a team player who thrives in a fast-paced dynamic team environment.
• Ability to work with minimal supervision, to set priorities to meet timelines, and to motivate and influence others. Prior management experience is required.
• Previous experience in successfully leading assigned activities within cross-functional teams.
• Proficiency in using SharePoint, Veeva and Microsoft Office applications required (MS Outlook, MS Word, MS Excel, MS PowerPoint).

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 $265,000 - $300,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. 

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 Sr. Director of Clinical Development will serve as a key leader in driving the clinical strategy and execution of one or more development programs. This role will be responsible for 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 Sr. Director will collaborate with cross-functional teams, lead regulatory submissions, and establish critical partnerships with key opinion leaders and external stakeholders to advance clinical initiatives. The ideal candidate will bring a strategic vision, proven expertise in 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, shaping the company’s success in the rapidly evolving field of neurology. 

Responsibilities include: 

• Lead the strategic direction and execution of clinical development programs, from early-phase through late-stage clinical trials ensuring they are scientifically robust and meet regulatory requirement. 
• Collaborate cross-functionally with teams in clinical operations, regulatory affairs, medical affairs, pharmacovigilance, and biostatistics to ensure the successful execution of clinical development plans.  
• Drive the preparation, submission, and management of regulatory filings, including clinical trial applications, investigator brochures, and study protocols, ensuring alignment with global regulatory guidelines (FDA, EMA). 
• Analyze, interpret, and communicate clinical trial 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 PhD in Neurology, Neuroscience, or a related field.  
• Over 10 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: $336,000 - $374,000

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. 

#LI-DM1