Role Overview

We are seeking a Sr. Technical Product Manager to lead the strategy and execution of data product, AI/ML system, AI-powered tooling, and automation initiatives across Patient Experience and Commercial Operations functions. This role is focused on improving how patients navigate testing and billing while enabling operational teams to efficiently progress cases from order to completion. You will play a crucial part in supporting initiatives to reduce friction, improve patient trust, and increase operational efficiency, ultimately driving better conversion, collections, and experience.

This role focuses on building, scaling, and leveraging platforms and products that power decision intelligence and activity orchestration across these domains. You will work in close collaboration with domain leaders while building through centralized Data & AI organization platforms, standards, and governance. You will own the full product lifecycle from discovery through production, ensuring solutions are adopted, trusted, and deliver measurable business impact. In doing so, you will work hands-on as an empowered builder of AI and software solutions to improve workflow efficiency, productivity, and quality for the teams you support.

This is a technical product role requiring fluency in data systems, modern data platforms, ML, and AI implementation patterns (and the ability and drive to build with them directly), combined with strong experience and stakeholder intuition across the associated functions. The role has direct ownership of high-impact initiatives that deeply influence organizational success.

What You’ll Do

Strategy & Roadmap

• Define and own the Data & AI product strategy and roadmap for the Patient Experience + Commercial Operations pod by deeply partnering with business leaders to proactively identify high-impact opportunities, shape problem definitions, and drive aligned priorities
• Translate ambiguous business problems (e.g., stuck cases, fragmented patient communication, support inefficiencies, billing friction) into clear product direction and measurable outcomes
• Own the line between 'what the business needs' and 'what gets built' end-to-end

Discovery, Experimentation, & Requirements

• Develop deep context on the domain so you can proactively propose solutions rather than field requests
• Be hands-on with data: query datasets, review schemas, and validate assumptions through analysis
• Lead end-to-end product discovery with interviews, workflow mapping, data assessments, ROI modeling, etc.
• Define clear product requirements (PRDs, user stories, acceptance criteria) and success metrics
• Design and run experiments to validate product performance and measure causal impact
• Establish leading indicators and KPIs for proactive product and process health assessments

Delivery, Data, & ML Lifecycle

• Partner with data and AI/ML engineering resources to deliver scalable products and capabilities
• Guide development of robust data pipelines and unified data models (360° views across key entities)
• Own the end-to-end ML lifecycle: feature definition, evaluation, deployment, monitoring, drift detection, and retraining
• Ensure training–serving consistency, model versioning, and clear deployment decision gates
• Establish strong observability across data pipelines and models (data quality, latency, reliability, cost)

AI Productization & Hands-On Building

• Define and implement AI product patterns, including agentic workflows and tool/function-calling integrations
• Build process automations and internal tools that improve workflow efficiency, productivity, and output quality for the teams you support
• Establish evaluation frameworks for LLM-powered features (faithfulness, relevance, safety, cost, latency)
• Implement prompt strategies, guardrails, and continuous evaluation pipelines

Governance, Compliance, & Data Quality

• Ensure products meet regulatory and compliance requirements
• Champion data quality, lineage, and reliability through data contracts and observability standards
• Maintain strong documentation practices (e.g., model cards, dataset documentation, audit trails)
• Partner with governance teams (Security, Legal, Compliance, AI Governance) to operationalize AI responsibly

Adoption, Change Management, & Impact

• Launch products with supporting enablement activities to ensure solutions are embedded in workflows with confidence
• Partner with stakeholders to integrate products into proactive, day-to-day decision-making
• Monitor product usage, performance, and business outcomes to iterate based on data and feedback
• Quantify and communicate impact (e.g., revenue lift, cost reduction, cycle time improvements, case completion turnaround)
• Influence Patient Experience and Commercial Operations stakeholders through delivery, not authority

Qualifications

Required

• 7+ years of relevant experience (e.g., product management, applied AI/ML engineering, technical founder, forward-deployed engineering), including 3+ years building data products, AI/ML systems, or related platforms
• Demonstrated domain fluency in Patient Experience and/or Commercial Operations
• Strong understanding of patient journeys, support channels (e.g., chat, voice, call centers), and operational workflows that drive conversion and test completion
• Familiarity with key domain-relevant tooling (e.g., patient portals, support platforms) and associated data
• Strong technical capability (e.g., comfortable scripting, performing EDA, with AI-aided application development)
• Hands-on experience shipping LLM-powered features or automations (e.g., prompting, RAG, tool/function calling, agentic orchestration, evals)
• ML/MLOps literacy (evaluation metrics, experimentation, feature stores, CI/CD, monitoring, drift)
• Familiarity with modern data stacks (e.g., Snowflake, dbt, AWS/SageMaker, Airflow/Dagster)
• Strong stakeholder leadership and communication skills, with the ability to work across technical and business teams
• Experience working in regulated environments (e.g., healthcare, life sciences, fintech)

Preferred

• Experience in healthcare, diagnostics, life sciences, and/or digital health
• Familiarity with healthcare data domains and systems, including patient, provider, payer, claims, billing, and clinical trial data
• Experience with vendor evaluation, platform selection, or external AI tooling ecosystems
• Advanced degree in a technical and/or business discipline

What Success Looks Like

• Production-grade data and AI products are deployed and embedded in day-to-day decision-making workflows
• Process automations and internal tools you build are reducing manual effort and improving output quality across the teams you support
• Measurable improvements seen in key business metrics (e.g., case completion turnaround time, patient satisfaction, cost-to-serve)
• Reliable, high-quality data foundations connect patient, provider, clinical, operational, and billing/financial insights end-to-end
• AI systems are continuously monitored, evaluated, and improved with measurable business impact
• Stakeholders trust and adopt implemented solutions across both corporate and business-unit teams
• Internal teams have transparent access to the function's roadmap, trust in delivery against it, and visibility into the evaluation logic that prioritizes initiatives based on their impact to organizational goals

Team Description:

The Brain Computer Interface (BCI) Applications Team is responsible for delivering a product that gives people with paralysis the ability to control computers, phones, and robotic arms with their minds at the same speed and functionality level as able-bodied people can. The team works closely with the PRIME clinical study patients which allows them fast and direct feedback about new features from users. The work in the team is multidisciplinary and team members have diverse backgrounds in software engineers, design engineering, ML engineering and neuro-engineering.

Job Description and Responsibilities:

As a Software Engineer in the BCI team, you will collaborate with our users, specifically clinical trial participants, to comprehend their requirements and engineer brain-computer interface software systems that deliver exceptional user experiences. You will take the lead in creating innovative applications, implementing new features, and resolving existing issues to enhance the overall functionality of the software.

• Develop, test, and validate software systems
• Work with cross-functional teams to design new BCI functionalities and novel computer user interfaces
• Work with study participants to iterate on and further refine the software
• Mentor others in achieving engineering excellence and be a catalyst on the team through code review, design review, and technical presentations
• Write algorithms to decode brain activity
• Design user experiences centered around brain control

Note: The team is hiring software engineers at all levels, both junior and senior. What matters most is evidence of exceptional abilities and a drive to succeed.

Required Qualifications: 

• Strong experience with full-stack development; experience with native (desktop/ Android/ iOS) preferred 
• Strong experience in operating system knowledge in low latency concurrency programming, memory management and networking
• Fluent in programming languages such as Swift, Objective-C, Kotlin or Java
• Experience in architecting elegant, maintainable, performant and reliable user facing software applications 
• Evidence in delivering high-impact projects to users or businesses with clear metrics and fast iteration cycle
• Evidence of exceptional ability in engineering
• Strong understanding of engineering first principles
• You are resourceful, flexible, and adaptable; no task is too big or too small
• Excellent communication and collaboration skills
• Bachelor’s degree in Computer Science or a related field or equivalent experience

Fast forward to 37:43 to learn more about software and UI:

Team Description:

The Brain Computer Interface (BCI) Applications Team is responsible for delivering a product that gives people with paralysis the ability to control computers, phones, gaming consoles, and robotic arms with their minds at the same speed and functionality level as able-bodied people can. In addition,the team is also working on restoring speech to mute individuals, this will also open the option for direct and natural silent communication with AI agents.  The team works closely with the PRIME clinical study patients which allows them fast and direct feedback about new features from users. The work in the team is multidisciplinary and team members have diverse backgrounds in software engineers, design engineering, ML engineering and neuro-engineering.

Job Description and Responsibilities:

As a Software Engineer Intern  in the BCI team, you will collaborate with our users, specifically clinical trial participants, to comprehend their requirements and engineer brain-computer interface software systems that deliver exceptional user experiences. You will take the lead in creating innovative applications, implementing new features, and resolving existing issues to enhance the overall functionality of the software. Additionally, you will be expected to:

• Develop, test, and validate software systems
• Work with cross-functional teams to design new BCI functionalities and novel computer user interfaces
• Work with study participants to iterate on and further refine the software
• Design and implement algorithms to decode brain activity
• Design user experiences centered around brain control

Required Qualifications:

• Strong experience with full-stack development 
• Fluent in programming languages such as Swift, Objective-C, Kotlin or Java
• Experience in architecting elegant, maintainable, performant and reliable user facing software applications 
• Evidence in delivering high-impact projects to users or businesses with clear metrics and fast iteration cycle
• Evidence of exceptional ability in engineering
• Strong understanding of engineering first principles
• You are resourceful, flexible, and adaptable; no task is too big or too small
• Excellent communication and collaboration skills
• Currently pursuing a Bachelor’s degree in Computer Science or a related field 

Preferred Qualifications:

• Experience with native (desktop/ Android/ iOS) preferred 
• Strong experience in operating system knowledge in low latency concurrency programming, memory management and networking

Team Description:

The Neuralink Clinical team is at the heart of an ecosystem that merges neuroscience, engineering, and medicine. We work to shape the future of brain-computer interface (BCI) technology through the planning, launch, and execution of groundbreaking human clinical trials. Our team is built on a foundation of excellence, aiming to uphold the highest standards of Good Clinical Practice (GCP) while redefining what’s possible and revolutionizing the way people interact with technology. Through strict compliance with ethical and regulatory protocols, we focus on ensuring the well-being of our trial participants while advancing the frontiers of neuroscience! Every day will bring fresh challenges and unprecedented opportunities to pioneer new approaches in the pursuit of our mission. From navigating regulatory pathways, designing trial protocols and documentation, and executing clinical trials, our team is instrumental in translating Neuralink’s BCI technology for use in people!

Job Description and Responsibilities:

As a Field Clinical  Engineer, you will be on the front lines of Neuralink’s clinical programs, working directly with participants, clinicians, and internal teams to translate cutting-edge neurotechnology into meaningful functional outcomes. This role is ideal for individuals with a background in PM&R, occupational therapy, or physical therapy who also have experience in medical devices and thrive in dynamic clinical environments.

You will play a critical role in bridging clinical care, engineering, and research by supporting device use, optimizing participant performance, and ensuring high-quality data collection in both clinical and home settings.

This role requires someone who is hands-on, clinically grounded, technically curious, and able to adapt quickly. You should be comfortable working with participants with significant neurological impairments and motivated by improving independence and quality of life.

In this role, you will:

• Work directly with study participants to support device use, training, and optimization during clinical sessions and at home
• Apply principles of rehabilitation (PM&R, OT, PT) to maximize participant outcomes and functional performance with the system
• Collaborate closely with surgeons, investigators, and site staff to ensure seamless clinical execution across all phases of the study
• Serve as the primary interface between participants and the technology, troubleshooting issues in real time and escalating when needed
• Support surgical and post-operative workflows, including intraoperative and early post-implant sessions where applicable
• Ensure high-quality, protocol-compliant data collection by aligning participant activities with study endpoints and data capture requirements
• Partner with clinical, engineering, and data teams to translate real-world use into actionable insights for product and algorithm development
• Identify trends in participant performance, usability challenges, and safety signals, and communicate clearly to cross-functional teams
• Contribute to development and refinement of training protocols, user workflows, and clinical best practices
• Support site onboarding, training, and ongoing engagement to ensure consistency and scalability across clinical sites
• Assist in preparation for regulatory inspections and ensure activities are conducted in compliance with GCP, protocol requirements, and internal procedures
• Travel to clinical sites as needed to support study execution and participant care

The ideal candidate:

• Has a clinical background in PM&R, occupational therapy, or physical therapy, with hands-on experience working with neurological populations (e.g., SCI, ALS, stroke)
• Has experience working with medical devices in a clinical or field-based role
• Is highly adaptable, proactive, and comfortable operating in a fast-paced, evolving environment
• Is technically curious and able to engage with engineers to troubleshoot and improve system performance
• Communicates clearly and builds trust with participants, clinicians, and cross-functional teams
• Is detail-oriented and understands the importance of protocol adherence and data integrity in clinical research

Required Qualifications: 

• Clinical training and hands-on experience in PM&R, occupational therapy, or physical therapy, with a focus on neurological populations (e.g., SCI, ALS, stroke)
• 3+ years of experience in a clinical, field-based, or medical device–adjacent role (rehab, neuromodulation, assistive technology, or similar)
• Demonstrated experience working directly with patients and clinicians in dynamic care environments
• Strong problem-solving skills with the ability to troubleshoot clinical and technical issues in real time
• Ability to interpret participant performance, functional outcomes, and device behavior to inform next steps
• Comfort working with technology, including basic data review and interaction with software-driven systems (no need to be a coder, but not afraid of one either)
• Working knowledge of clinical research principles, including protocol adherence, endpoint-driven activities, and data quality expectations
• Familiarity with Good Clinical Practice (GCP) and general clinical study conduct
• Ability to collaborate effectively across clinical, engineering, and operations teams
• Strong communication skills, with the ability to engage both participants and highly technical teams
• High attention to detail, with the ability to manage multiple participants, sites, and priorities simultaneously
• Willingness to travel frequently to support clinical sites and participants

Preferred Qualifications:

• Degree or formal training in bioengineering, biomedical engineering, or a related field, with exposure to neurotechnology or implantable systems
• Experience working with neuromodulation, brain-computer interfaces, or other neurorehabilitation technologies
• Prior experience in a clinical field engineer, clinical specialist, or applications role within a medical device company
• Experience supporting surgical procedures, intraoperative environments, or early post-implant programming and troubleshooting
• Familiarity with signal-based systems (e.g., neural data, EMG, EEG) and comfort interpreting system performance in real time
• Exposure to rehabilitation technology integration, including assistive devices, digital interfaces, or adaptive control systems
• Experience supporting multi-site clinical studies or working directly with investigators and study coordinators
• Comfort working with data systems (e.g., EDC platforms, basic data visualization tools) to review participant performance and study metrics
• Understanding of usability, human factors, and patient-centered design principles
• Prior involvement in training clinicians or participants on device use and workflows
• Experience working in early-stage or rapidly evolving clinical programs where processes are still being defined

Team Description:

The Convoy team, a specialized group within the Robot Mechanical Engineering team, is working on developing a first-of-its-kind brain-controlled assistive robotic arm (ARA). Our focus is on developing high-dimensional neural control of hardware, specifically robotic arms and hands. We design and integrate robotics systems, work directly with our clinical trial participants, and collaborate cross-functionally with hardware, software, electrical, and BCI engineers. We believe this work may be one of the best and most advanced paths to giving physical independence back to users with unmet medical needs.

Job Description and Responsibilities:

As a Mechanical & Robotics Engineer at Neuralink, you will design and produce hardware solutions for our assistive robotic arm. Your responsibilities may also include working on our brain-computer interface devices, surgical robotics, automation, microfabrication, and more. You will have the opportunity to own projects from concept to production, leveraging your mechanical engineering background in the challenging field of brain interfaces and human-robot interaction. Your responsibilities will include:

• Designing and integrating robot mechanical and electrical components and assemblies with a heavy emphasis on usability and safety
• Collaborating with clinical trial participants, neuroscientists, biologists, and engineers to establish design criteria
• Rapidly and effectively building systems to meet project goals
• Applying analytical methods, including calculations and simulations, for the design and optimization of structures and mechanical components
• Actively driving every phase of device launch, from hands-on early feasibility prototyping through manufacturing release

Required Qualifications:

• Bachelor’s degree in one of the following disciplines or equivalent experience: Mechanical Engineering, Robotics, Mechatronics
• Strong understanding of engineering first principles
• Minimum of 3 years of mechanical engineering industry experience, including internships and project teams where you owned products from concept to production
• Proficient in 3D CAD

Preferred Qualifications: 

• Experience with robotic systems such as robot arms, grippers, actuators, human-robot interaction
• Multidisciplinary experience in robotics software and control (e.g., Python, ROS, MATLAB, control theory)
• Electrical engineering proficiency (e.g., PCB design, wire harnessing, circuit design)
• Proficiency with conventional machining and rapid prototyping technologies

Seeking talent neat: Princeton, NJ ; San Diego, CA

Position Summary:

In support of clinical development programs, the Director of Clinical Trial Materials role oversees Clinical Trial Material (CTM) planning and execution activities, supporting Phase 1-IV and IIS trials. Includes demand forecasting, determination of an appropriate presentation, setting production schedules, protocol review, ensures label compliance with applicable regulations, establishes optimal packaging & distribution strategies, tracks and reconciles drug supplies and monitors product re-test dates. Interface with internal departments and contract research organizations (CROs) as necessary to coordinate the execution of these activities.  Implements and ensures group compliance to procedures for the production and distribution of investigation product. Mentor junior colleagues in the CTM team as required. 

Primary Responsibilities:

• Review and Interpretation of a clinical protocol or study overview:
  • Review and provide feedback during the development of the clinical protocol.
  • Calculate total demand and translation of total demand into a demand forecast.
  • Interface with Project Managers to develop clinical supply timelines, obtain study overviews and drug requirements, and initiate procurement procedures.
  • Periodically reviews and updates inventories including all supply related information such as lot numbers, current status, and kit genealogy and expiration date extension.
  • Tracks expired materials and issues orders for retrieval or disposal.
  • Be proficient with current inventory and tracking systems by learning their usage, updates and maintenance.
  • Proposes and implements improvements to assure efficient clinical supply operations.
  • Investigates and resolves issues regarding inventory, shipments and returns.
  • Responsible for end to end, full CTM lifecycle, ensures that all clinical trials have timely and an un-interrupted supply of CTM.
• Coordinates CTM activities with Clinical Supply Packagers and Distributors, Technical Services, Clinical R&D staff, Project Teams, IT/IS, Data Management, CROs and other sites and departments as necessary
• Develops and maintains CTM documentation necessary to support company policies, procedures and all regulatory guidelines
• Works with Clinical, Regulatory and Quality teams in preparing label text, obtaining translations and approval of label proofs
• Prepares and reviews applicable contracts, project statements, change orders, packaging requests, and batch records for accuracy and completeness
• Reconciles and approves invoices
• Prepares reports to ensure accuracy and completeness of clinical supplies information.  Maintains departmental reports and files, updates SOPs and other projects as assigned

Education/Experience/Skills

• Minimum Bachelor of Science degree (BS) in Health Science (preferred Master of Science degree). Equivalent combination of relevant education and applicable job experience may be considered with at least 4-6 years of experience in pharmaceutical development focused on clinical trial materials
• The individual must be well versed in GXPs (GMP, GCP, and GDP) and as well as other regulatory requirements as they pertain to investigational products
• Proven project management skills
• Ability to handle multiple projects simultaneously
• Good understanding of GMP working environments and regulatory guidance and regulations (e.g. ICH, 21 CFR Part 11)
• Good understanding of IRT system build-up and user testing
• Good negotiating skills with customers and suppliers
• Hands on training and experience in clinical trial methodology and Good Clinical Practice
• Good organizational and documentation skills
• Demonstrated track record of ability to self-direct and resolve issues with the vendors, CRO staff and internal teams
• Excellent written and verbal communication skills
• Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization
• Skilled at creating a cooperative team environment
• Able to objectively evaluate situations and make recommendations for changes in light of overall project demands

Physical Requirements:

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

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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. 

About the role: We are hiring frontline sales professionals to be part of a diverse and elite biopharma sales team dedicated to helping patients in need. With a laser focus on the eye care customer, the Territory Leader will be responsible for territory disease state education along with the launch and ongoing growth of XDEMVY. They will deliver high standards for the ongoing launch and beyond and will champion a culture of outstanding performance, compliance and full ownership of all activity and results. The Territory Leader will be experts in account management, business ownership, sales execution, resource utilization, and they will build and foster relationships with key eye care customers. The Territory Leader will relentlessly pursue excellence to maximize sales in their territory while learning to adapt to changes and needs of the business. In doing so, they will have the unique opportunity to meaningfully contribute to the growth and performance of Tarsus. This critical sales role will be ideal for someone who thinks strategically, operates with tactical precision and strives for excellence.

Geography: Fremont, Oakland, Berkeley, Walnut Creek, PLeasanton, Antioch, Brentwood, Concord, San Ramon, Livermore, Danville, Stockton and Turlock.

Let’s talk about some of the key responsibilities of the role:

Account Management & Eye Care Experts

• Experts in eye care clinical information: anatomy, disease state, products, XDEMVY and office treatment patterns
• Experts in selling skills and account development including building relationships with all key stakeholders
• Experts in pull through tactics with a full understanding of managed care hurdles
• Understand all functions within an ophthalmology/optometry practice and how their roles impact product prescribing and pull through
• Maximize managed care opportunities within the territory and have an understanding of how it impacts the District, Region and Nation and share important feedback
• Understand key opinion leaders within respective geographies and foster engagement with Tarsus leadership
• As eye care experts, champion compliant promotion in alignment with our corporate values

Business Acumen & Sales Execution

• Drive top tier execution by exceeding sales performance goals and key productivity metrics across the territory
• Use expert analytical skills to guide highly productive activity – prioritize key customer engagements, drive reach and frequency to extend depth and breadth of product trial and utilization
• Drive a successful launch and ongoing performance by monitoring all key performance metrics weekly, monthly, quarterly, and annually – ability to adjust approach as needed based on data
• Ensure actionable business plans are set - align all selling activities to drive impact
• Share ongoing insights with leadership and internal stakeholders to ensure feedback is captured
• Personal accountability for driving the highest standards of ethics and compliance

Business Owners & Culture Champions

• Drive our culture of commitment, empowerment and teamwork which includes extreme ownership, high accountability, continuous improvement and relentless pursuit of excellence
• Achieve success and be prepared to adapt in a complex selling environment partnering with many stakeholders: district leaders, marketing, market access, medical affairs, sales ops, inside sales, training, and other important stakeholders
• Provide frontline feedback and intel to sales leadership and the broader organization
• Ensure PDMA compliance and adhere to all company & industry compliance guidelines
• Share ongoing best practices among peers and leadership to elevate national performance
• Maximize all key resources that lead to territory success

Factors for Success:

• Bachelor’s degree in business, science, or related field or commensurate experience
• 2+ years pharmaceutical sales / relevant healthcare sales experience or a proven track record of business to business sales - required
  • Proven track record of pharmaceutical launch experience - strongly preferred
  • Eye Care experience- preferred
• Established track record with evidence of excellent problem solving and collaboration
• Highly adaptable to change, able to quickly pivot and respond given new market information in a fast-paced environment
• Strong communication and change management skills
• Proven ability to escalate difficult issues and make tough decisions
• Established track record in the following job competencies:
  • Selling skills
  • High performance
  • Impact & influence
  • Customer focus & account management
  • Maximizing resources
  • Analytical skills
  • Relationship building
  • Decision making & judgment
  • Teamwork & collaboration
  • Adaptability & GRIT

A Few Other Details Worth Mentioning:

• This is a field-based position reporting to the District Sales Leader
• Geography: Candidates must live in Livermore/ Danville/ Stockton/ or Turlock.
• Travel will be required within the selling geography and beyond to sales meetings, possibly across various customer conventions and occasional travel to HQ in Irvine CA
• 40% - 50% travel required in some larger geographies
• Territory Leader Salary Range;
• • Associate Territory Leader – 2+ years proven B2B selling - $110,000
  • Territory Leader – 1-2 years pharma selling - $123,000
  • Territory Leader – 2-5 years pharma selling - $139,000
  • Sr. Territory Leader – 5-8 years pharma selling - $145,000
  • Sr. Territory Leader – 8+ years pharma selling - $161,000

At Tarsus, we understand the importance of attracting and retaining top talent. In addition to a competitive base pay, we offer an incentive bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot.

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About Natera

Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to helping families and healthcare providers make more informed decisions. Through cutting-edge technology and a commitment to innovation, Natera offers genetic testing solutions that span reproductive health, oncology, and organ health. We are passionate about delivering accurate, actionable insights that improve patient outcomes and transform the way diseases are detected and managed.

POSITION SUMMARY:

The Lead Paralegal, Healthcare Transactions is an individual contributor who performs general legal review and analysis, and provides advice on a variety of matters in a busy, high-performing legal department within a cutting-edge molecular diagnostics company. This position will have a focus on supporting research activities performed under Attorney oversight. Experience in drafting commercial and research agreements is a must. This is a mid-senior level transactional Paralegal position, however Natera often encourages employees to take on additional assignments and projects that interest them and they are capable of. This position requires being a nimble Paralegal who can focus on key risks and provide clear, focused, actionable advice and timely review. 

PRIMARY RESPONSIBILITIES:

• Independently draft, review, and negotiate a wide range of contracts needed for the effective functioning of the Company, focusing mainly on research collaboration agreements, investigator initiated trial agreements, clinical study agreements, material transfer agreements and data use agreements with Attorney oversight.

• Perform legal review and approval of other company documents, such as clinical study consent forms and study protocols.

• Appropriately manage a heavy workflow, setting priorities with internal clients and meeting deliverable timelines.

• Liaise with internal clients and respond to inquiries regarding contracts and other matters, as assigned.

• Learn and contribute to the ongoing development of the Legal Department “playbook” for contract negotiations.

• Collaborate closely with attorneys to design, implement, and refine efficient workflows that streamline the contracting lifecycle, including template management, intake triage, document tracking, and coordination across business stakeholders to improve turnaround times and operational consistency.

• Employees must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.

• Must maintain a current status on Natera training requirements.

QUALIFICATIONS:

• 5+ years of experience as a Paralegal in commercial research contracts and general corporate practice, including 3+ years of experience in a major law firm; in-house experience a big plus.

• Experience in advising clients in biotech, life science and/or health care industries.

• Experience in reviewing, drafting, negotiating and finalizing commercial contracts, including complex arrangements independently, with Attorney oversight

KNOWLEDGE, SKILLS, AND ABILITIES:

•  Strong analytical, communication and written skills.

• Strong interpersonal skills and business acumen.

• Ability to multitask and strong attention to detail

• Nimbleness; ability to thrive in a fast-paced, dynamic environment.

• High levels of initiative, confidence and ability to appropriately influence others.

• Demonstrated high ethical behavior.

• Strong technology skills and proficiency with Microsoft Office, including Word, PowerPoint and Excel.

POSITION SUMMARY:

Natera is seeking a highly motivated and experienced Clinical Scientist to support the development and execution of our innovative Oncology programs.

The Director, Clinical Science will ensure the successful execution of clinical development programs and deliverables in partnership across the organization, with external vendors, and with external academicians and collaboration partners. The Director, Clinical Science will be accountable to jointly develop clinical program strategy and work collaboratively together with other functional representatives to assure that activities are executed within expected scope, compliance, budget, and timelines. Specifically, the candidate will work closely with colleagues cross functionally in clinical development, clinical operations, data management safety/pharmacovigilance, regulatory, biostatistics, translational medicine, and program leadership.

PRIMARY RESPONSIBILITIES:

• Develop study concepts, including study design, schedule of assessments, objectives/endpoints, and eligibility criteria  
• Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required
• Provide protocol training and contribute to CRF design
• Ensure study manuals align with protocol and engage investigators in study design
• Seek input from key investigators on study design and methodology to ensure alignment with research objectives, and actively participate in pre-site selection discussions, site initiation visits, and investigator meetings to support successful study execution
• Contribute to and oversee real-time clinical data reviews (including oversight of CROs when applicable)
• Serve as a clinical science representative on internal and external meetings 
• Develop clinical project execution timelines and provide status updates to senior management to ensure the timely delivery of program milestones
• in collaboration with Data Management will develop Data Review Plan, and monitor clinical data for specific trends, ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
• Support meetings (advisory boards, etc) and deliver presentations
• Drive clinical research plans, including company and investigator-initiated studies
• Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives 
• Build relationships with KOLs, consortiums, and sites
• Provide scientific input into design & implementation of clinical trial(s), their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for registration of the product 
• As appropriate, participates in ongoing enhancements/development of team processes, structures, systems, tools, and other resources; As appropriate, coaches and guides less experienced Clinical Scientists
• Manage one or more direct reports including being responsible for hiring, training, developing, and retaining talent on staff, as needed
• As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
• Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
• Ensure HIPAA/PHI compliance and maintain training requirements
• Perform other duties as assigned

QUALIFICATIONS:

• Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field) preferred
• 10+ years of pharma/biotech industry experience in clinical development in oncology clinical trials
• Deep understanding and preferably experience in oncology molecular diagnostics, oncology companion diagnostics or early cancer detection 
• Experience in data review, data cleaning, managing and interpreting clinical trials results as well in writing clinical trial protocols
• Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research
• Experience with managing direct reports, ensuring that roles are performed in accordance with job descriptions and that training is conducted and maintained appropriately

KNOWLEDGE, SKILLS, AND ABILITIES:

• Problem-solving skills and a fast learner
• Strong communication (oral and written) and attention to detail
• Ability to work independently and collaboratively
• Analytical and creative thinking
• Familiarity with Google and Microsoft suites
• Desire to work in a dynamic environment
• "Hands-on" leadership and a strong work ethic
• Ability to apply business knowledge, exercise judgment, and escalate issues appropriately
• Strong project management, organizational, and interpersonal skills
• Adaptability, initiative, and team-building skills
• Demonstrated success in working in a cross-functional environment
• Successful and superior influencing skills across all levels of the organization and external collaborators
• Conflict resolution and follow-through skills
• Results and goal-oriented
• Strategic and flexible thinking

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• Office or home office setting with internet access
• Ability to use a computer, phone, and read materials 
• Flexibility to work with colleagues in a global setting
• Able to engage in work-related travel up to 25%

POSITION SUMMARY:

Natera is seeking a highly motivated and experienced Clinical Scientist to support the development and execution of our innovative Oncology programs.

The Associate Director, Clinical Science will ensure the successful execution of clinical development programs and deliverables in partnership across the organization, with external vendors, and with external academicians and collaboration partners. The Associate Director, Clinical Science will be accountable to jointly develop clinical program strategy and work collaboratively together with other functional representatives to assure that activities are executed within expected scope, compliance, budget, and timelines. Specifically, the candidate will work closely with colleagues cross functionally in clinical development, clinical operations, data management safety/pharmacovigilance, regulatory, biostatistics, translational medicine, and program leadership.

PRIMARY RESPONSIBILITIES:

• Develop study concepts, including study design, schedule of assessments, objectives/endpoints, and eligibility criteria  
• Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required
• Provide protocol training and contribute to CRF design
• Ensure study manuals align with protocol and engage investigators in study design
• Seek input from key investigators on study design and methodology to ensure alignment with research objectives, and actively participate in pre-site selection discussions, site initiation visits, and investigator meetings to support successful study execution
• Contribute to and oversee real-time clinical data reviews (including oversight of CROs when applicable)
• Serve as a clinical science representative on internal and external meetings 
• Develop clinical project execution timelines and provide status updates to senior management to ensure the timely delivery of program milestones
• in collaboration with Data Management will develop Data Review Plan, and monitor clinical data for specific trends, ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
• Support meetings (advisory boards, etc) and deliver presentations
• Drive clinical research plans, including company and investigator-initiated studies
• Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives 
• Build relationships with KOLs, consortiums, and sites
• Provide scientific input into design & implementation of clinical trial(s), their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for registration of the product 
• As appropriate, participates in ongoing enhancements/development of team processes, structures, systems, tools, and other resources; As appropriate, coaches and guides less experienced Clinical Scientists
• Manage one or more direct reports including being responsible for hiring, training, developing, and retaining talent on staff, as needed
• As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
• Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
• Ensure HIPAA/PHI compliance and maintain training requirements
• Perform other duties as assigned

QUALIFICATIONS:

• Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field) preferred
• 8+ years pharma/biotech industry experience in clinical development in oncology clinical trials
• Deep understanding and preferably experience in oncology molecular diagnostics, oncology companion diagnostics or early cancer detection 
• Experience in data review, data cleaning, managing and interpreting clinical trials results as well in writing clinical trial protocols
• Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research
• Experience with managing direct reports, ensuring that roles are performed in accordance with job descriptions and that training is conducted and maintained appropriately

KNOWLEDGE, SKILLS, AND ABILITIES:

• Problem-solving skills and a fast learner
• Strong communication (oral and written) and attention to detail
• Ability to work independently and collaboratively
• Analytical and creative thinking
• Familiarity with Google and Microsoft suites
• Desire to work in a dynamic environment
• "Hands-on" leadership and a strong work ethic
• Ability to apply business knowledge, exercise judgment, and escalate issues appropriately
• Strong project management, organizational, and interpersonal skills
• Adaptability, initiative, and team-building skills
• Demonstrated success in working in a cross-functional environment
• Successful and superior influencing skills across all levels of the organization and external collaborators
• Conflict resolution and follow-through skills
• Results and goal-oriented
• Strategic and flexible thinking

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• Office or home office setting with internet access
• Ability to use a computer, phone, and read materials 
• Flexibility to work with colleagues in a global setting
• Able to engage in work-related travel up to 25%

Position Title:   Director, Regulatory Affairs (Strategy, Immunology and Inflammation)

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

Nurix Therapeutics, Inc. is seeking a Director, Regulatory Affairs (Strategy, I&I) to join the Regulatory team.  The successful candidate will be a core member of the Regulatory team and will serve as the global regulatory lead (GRL) for the immunology and inflation therapeutic area. This role will be responsible for developing the global regulatory strategy in collaboration with key internal stakeholders, as well as tactical implementation of that strategy guiding and executing compliant, high quality, nonclinical and clinical submissions and interactions in support of early development, registration and life cycle management activities.  This position works cross-functionally with regulatory affairs and clinical development organizations to facilitate the completion of regulatory filing documentation according to company timelines. It also ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as required. This position is on site in the Brisbane, CA office.

Responsibilities:

• Develop and implement competitive and effective global clinical & nonclinical regulatory strategies for various immunology and inflammation indications and identify potential risks and mitigation strategies associated with proposed strategies
• Work in close collaboration with the SVP, Head of Regulatory Affairs and the development team leader and other cross-functional colleagues, including CROs to deliver sound, efficient development strategies and operational plans
• Represent Regulatory Affairs on assigned cross-functional development teams.
• Lead and manage the development and preparation of high-quality global submissions (including IND, CTAs, NDAs, and MAAs) for early and late-stage programs in collaboration with the regulatory and project teams to support and accelerate clinical development and regulatory approval, as applicable
• Lead communication with global Health Authorities (HA), such as FDA and EMA, including, planning and preparing for formal meetings with regulatory agencies and interpreting HA feedback from these interactions.
• Develops and executes, or oversees global regulatory strategy for long-term planning, including the potential to accommodate expedited development needs
• Anticipate issues and guide cross-functional teams on risk mitigation strategies for any development challenges Provides insight and guidance on the implementation of current regulations and assesses regulatory risk based on precedence
• Ensure adherence to current regulations associated with regulatory activities
• Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix’s investigational and marketing applications
• Plays an essential part in defining requirements for, implementing, and supporting future systems and tools to be employed by Nurix in the areas of document management, submission content planning, and regulatory information management
• Tracks the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependencies
• Develops and maintains submission plan templates to ensure Nurix regulatory submissions are consistently planned and executed across programs
• Participates in cross-functional process initiatives impacting regulatory submission processes and systems
• Manages consultants and contractors as needed

Requirements

• Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred Manager:
• Must have minimum of 12 years in Regulatory affairs strategy with significant experience in the immunology and inflammation therapeutic area
• Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulations
• Experience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMA
• Proven track record of supporting Regulatory affairs in the planning and execution of major filings and ongoing maintenance of clinical trial and marketing applications
• Strong project management and critical thinking skills
• Experience applying project management techniques and tools (e.g., MS Project, Smartsheet, Excel trackers) to the planning and execution of regulatory submissions
• Excellent organizational and communication skills, both written and verbal
• Ability to work independently as well as part of a team environment
• Positive attitude, energetic and proactive
• Proven ability to manage multiple projects, identify and resolve regulatory issues
• Strong interpersonal skills and the ability to effectively work with others

Salary Range:  220K – 254K plus bonus and equity.

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

Summary 

The Senior MSL is a U.S. field-based role within Medical Affairs, reporting to the Executive Director, Medical Affairs. This role will be a core member of Tango’s growing field medical team during a critical phase of development.

The Senior MSL will be responsible for high‑quality scientific exchange, trial execution support, medical education, and insight generation across priority solid tumor indications, with an initial focus on pancreatic cancer (PDAC), non-small cell lung cancer (NSCLC), and our evolving pipeline programs.

This role is ideal for an individual who wants to operate at the intersection of clinical development, external scientific engagement, and launch readiness in a late-emerging biotech environment, where individual impact is high and scientific accountability matters.

Your role

      Primary Focus: Solid tumors (pancreatic cancer (PDAC), non-small cell lung cancer (NSCLC)

      Scientific Exchange & External Engagement

What You Bring

      Education & Experience

• 8 years of relevant experience with a bachelor’s degree, 6 years with a master’s degree, or 3 years with an advanced scientific or medical degree (e.g., PharmD, PhD, MD) Candidates with advanced clinical degrees (e.g., NP, PA) and significant oncology Medical Science Liaison experience will also be considered.
• Experience in PDAC, GI malignancies, or NSCLC strongly preferred
• Prior experience supporting clinical-stage or pre-launch oncology assets highly valued

      Skills & Attributes

• Strong scientific acumen with the ability to engage deeply on complex biology and emerging clinical data
• Demonstrated strength in insight generation, synthesis, and communication
• Comfortable operating in a fast-moving, high-accountability biotech environment
• Excellent collaboration skills across matrixed teams
• Strong understanding of U.S. clinical research and healthcare environments

      Compliance & Technical Requirements

• Working knowledge of FDA, OIG, ICH, GCP, PhRMA Code, and applicable compliance standards
• Commitment to compliant, ethical scientific exchange
• Proficiency in standard business and field tools (CRM, MS Office, virtual engagement platforms)

Work Environment

• Field-based role in California, with residence required within assigned territory
• ~ 50% domestic travel expected, with significant time spent with external scientific partners

Why Join Tango Medical Affairs?

• Be part of a Medical Affairs team built for a transition from mid-stage to late-stage development
• Contribute directly to trial success, data readiness, and future regulatory and commercialization pathways
• Expand and establish Tango as a credible clinical scientific leader in precision oncology
• Work in a lean, collaborative environment where your scientific judgment and execution matter

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

#LI-Remote

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

About the Role

Join us in advancing our pipeline to address a number of diseases across therapeutic categories including eye care, dermatology, and other diseases with high unmet needs.

This role will be focused on the development of clinical strategies for assigned programs and is responsible for ensuring effective and efficient execution of the clinical development plan

Let’s talk about some of the key responsibilities of the role:

• A leader with influence to present and collaborate with cross-functional team members to synthesize clinical data.
• Primary author for assigned clinical trial protocols, collaborating with and leading with other functions required for protocol development.
• Contributes or reviews clinical, regulatory, and relevant study documents, including Investigator Brochures, Clinical Study Reports, Statistical Analysis Plans, Operation Manuals, Investigational New Drug Applications/Clinical Trial Applications, case report forms, and data tables listings and figures.
• Educates internal and external team members on protocol execution.
• Primary point of contact to address or properly triage inquiries from site, CRO personnel, and site monitors, regarding study protocol, informed consent, and patient-specific questions.
• Reviews, finalizes, and updates information/data entered in clinical trial registries.
• Participates in development of Clinical Development Plan.
• Partners with data management on resolution of all clinical queries to sites.
• May participate in health authority interactions, as well as interactions with site Institutional Review Boards/ethics committees.
• Contributes to scientific abstracts for submissions to scientific conferences and publications for peer-reviewed journals.
• Creates, reviews, and/or presents clinical slides for internal meetings and external forums.
• Collaborates with biostatistics to develop data tables, listings, and figures.
• Identifies and tracks any potential safety events within a given study, or across studies for assigned programs.
• Conducts medical data review.
• Provides clinical development input to proposed revisions of SOPs and guidance documents.

Factors for Success:

• Advanced clinical/science degree preferred (PharmD, PhD, OD, MD).
• 10+ years minimum experience, with 3+ years of pharma/biotech experience or demonstrates relevant equivalent clinical research experience (Clinical Scientist) and 5+ years of experience with clinical trials. Eye care experience preferred.
• Experience authoring clinical trial protocols and/or study results and conclusions, applying creative thinking and adaptability for early development programs
• In-depth understanding of drug development.
• Working knowledge of basic biostatistics
• Experience working with techniques of data analysis, interpretation, and assessment of clinical relevance.
• Well-versed in medical aspects of Good Clinical Practice, International Council for Harmonization, Food and Drug Administration, European Medicines Agency, National Institute for Health and Care Excellence and other relevant guidelines and regulations.
• Has demonstrated, through past experience, abilities to competently manage the majority of clinical science deliverables associated with assigned clinical studies.
• Strong presentation skills: effective at summarizing and presenting the key considerations and decision points.
• Confident and competent when interacting with varying levels of internal/external management, key opinion leaders, etc.
• Excellent teamwork and negotiation skills: knows how to complete deliverables by working effectively with others internally and externally; can effectively drive discussions and decisions toward desired end results.
• Able to work in a fast-paced dynamic organization.
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily, and provide support/expertise where needed.
• Tarsus Competencies:
  • Decision Making - Identifies, analyzes, and resolves issues or challenges effectively and efficiently. Demonstrates creativity, decisiveness, and the capacity to implement solutions in a structured and outcome-oriented manner. Navigates uncertainty when there’s not a blueprint for success. Owns their decisions and actions.
  • Collaboration and Team Building - Builds strong relationships and networks. Is curious about and respectful of different points of view. Cultivates a safe space for discussion readily engaging in group dialogue and debate. Puts the team first.
  • Outcome Driven - Clearly defines mutual expectations of self and others in a team setting. Adapts to changing business needs. Is determined and resourceful in finding solutions, even when faced with obstacles. Takes appropriate actions, including calculated risks, to ensure obligations are met. 

A Few Other Details Worth Mentioning:

• The position will be based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals. We provide a hybrid work environment. Remote work is an option.
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
• This position reports directly to the COO.
• Some travel may be required – up to 50%

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $165,000 - $231,000 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot.

#LI-Hybrid

#LI-Remote

Job Title: Executive Medical Director, Clinical Development         

Location: Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required.          .          

Role Overview: The Executive Medical Director of Clinical Development plays a key role in leading the design, execution, and oversight of clinical trials at an asset level, ensuring high-quality data generation to support the safety and efficacy of our pipeline products.  This role involves leading and developing a team and contributing to and influencing clinical development strategy across an asset, including study design, implementation, and data interpretation, while working cross-functionally to align clinical activities with overall development plans.  The Executive Medical Director collaborates closely with internal and external stakeholders to ensure trial execution meets regulatory, scientific, and business objectives in a fast-paced environment.  The role reports to the Vice President of Clinical Development. 

Key Responsibilities:

• Strategic Leadership:
• Drives the clinical development strategy for one or more assets
• Identifies critical clinical development milestones and ensures team alignment and accountability toward meeting timelines
• Provides leadership to the clinical team’s contribution to clinical study reports, key clinical documents, and regulatory submissions
• Directly manages and/or mentors Medical Directors, Clinical Scientists and other team members as appropriate
• Clinical Trial Design and Oversight:
• Leads and contributes to the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods
• Oversees the conduct of clinical trials, ensuring adherence to protocols and good clinical practice (GCP) guidelines, working closely with CROs and external partners to ensure efficient execution
• Reviews and interprets clinical data to assess the safety and efficacy of the investigational drug, driving timely, data-driven decisions
• Manages the clinical contribution to documents required during development (including but not limited to: Clinical Study Protocols, Investigator Brochures, Clinical Study Reports)
• Medical Expertise:
• Provides deep medical and scientific expertise in the therapeutic area, disease state, and potential drug effects 
• Reviews clinical data to identify and analyze safety concerns and adverse events, working with the pharmacovigilance team on continual benefit-risk assessment
• Stays current with relevant medical literature and clinical trial methodologies

• Contributes medical expertise to external interactions, including KOL engagement, advisory boards, and regulatory interactions as appropriate

• Cross-Functional Collaboration:
• Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pharmacovigilance, pre-clinical and project management teams to ensure alignment between clinical strategy and execution in a fast-paced environment
• Presents clinical data to internal and external stakeholders as appropriate
• People Leadership & Team Development:
• Leads and develops a high-impact team
• Provides coaching, mentorship, and performance management
• Fosters a culture of accountability, collaboration, and scientific rigor
• Supports hiring and resource planning in partnership with leadership

Qualifications:

• Medical degree (MD) ideally with board certification in a relevant specialty
• Extensive experience in clinical research and development, including within the pharmaceutical industry with progression of career demonstrating clinical leadership
• Proven people leadership experience, including managing and developing direct reports in small or growing teams
• Strong understanding of clinical trial design, GCP guidelines, and regulatory requirements, ideally with Phase 2 and 3 clinical study experience
• Excellent communication, leadership, and analytical skills
• Demonstrated ability to contribute to and influence clinical strategy while driving hands-on execution 

Experience working in a small or emerging biotech environment, with comfort operating in a fast-paced setting

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates is $331,000 to $368,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

Science 37’s Nursing Solutions Group brings together expert nurses who share a passion for organizing, planning and implementing mobile clinical nurse services to participants in clinical trials. Science 37’s extraordinary work environment allows continuous collaboration between clinicians, clinical researchers, patient recruitment specialists, data managers and technology developers. The Nursing Solutions Group is involved throughout the trial life cycle, from protocol development and feasibility analysis to clinical trial implementation and closeout.

The Per Diem Mobile Research Nurse is a Registered Nurse who will work per diem and has experience across multiple therapeutic areas with the ability to work independently and integrate well with the Nursing Solutions Group. With interest/expertise in Science 37’s decentralized model of care delivery, the Mobile Research Nurse will perform delivery of care to participants as well as collaborate with brick and mortar sites, if indicated, for shared clinical trial implementation. The Mobile Research Nurse ensures the professional delivery of patient care in compliance with all federal and state regulations, Good Clinical Practice, and Standard Operating Procedures. 

*This is a travel role that requires on-site visits to participants homes.

Duties for this position include but are not limited to:

1. Participate and provide research nurse services to qualified study participants at home
2. Apply clinical research and nursing practices to develop solutions to complex problems
3. Collaborate with Lead and Per Diem Mobile Research Nurses on solutioning, education, and resource support
4. Participate in activities that will further the operational development of Science 37 nursing service delivery
5. Develop relationships with study team members and serve as the subject matter expert (SME) on all nursing processes
6. Other duties as assigned as the needs of Science 37 evolve and change

This position has the following qualifications:

1. BSN degree preferred
2. Full Covid Vaccination strongly preferred. Science 37 follows CDC guidelines for vaccination recommendations and such guidelines are subject to change.
3. Active RN licensure in home state as well as eligibility for Compact Licensure required
4. Minimum 2+ years clinical/research experience preferred
5. Basic Life Support (BLS) Certification
6. Maintain a positive reflection of the company by representation in participant’s homes or in clinic settings
7. Travel and availability qualifications are as follows:
   1. 1-2 days minimum a week dedicated to support Science 37's study visits
      1. Weekday/night availability required
   2. Must be willing to travel to a participants homes 
   3. Active Driver’s License

Science 37 is looking for people with the following skills and competencies:

1. BSN degree preferred
2. Active RN licensure in home state as well as eligibility for Compact Licensure required
3. Minimum 2+ years clinical/research experience preferred
4. Basic Life Support (BLS) Certification
5. Active Driver’s License
6. Weekday/night availability required
7. Maintain a positive reflection of the company by representation in participant’s homes or in clinic settings
8. Up to 100% travel, as needed, for study participant visits, project team meetings, and other professional meetings/conferences as needed
9. Ability to obtain nursing license in multiple states based on study needs
10. Physical ability to perform nursing tasks and lift equipment up to 15 kg in weight
11. Access to a reliable vehicle to perform study participant visits and transport equipment
12. Ability to drive to local and/or remote locations to perform study participant visits
13. Ability to use technology effectively and appropriately for study participant assessments and documentation including but not limited to study participant care equipment, laptop computers, communication devices and tablets
14. Ability to communicate in English (both verbal and written)

There is minimal supervision for this position, with individuals reporting to the Manager, Nursing Solutions Group.

Compensation varies based on location and work being performed. The starting pay range for a candidate selected for this position is generally within the range of $50-55 per hour. Employees may be eligible for additional discretionary bonuses and commissions. The successful candidate’s actual pay will also be based on qualifications and experience, so the actual starting pay may be above or below this range.

Science 37 is an equal opportunity employer.  

We are committed to creating a diverse environment and is an equal opportunity employer. All qualified applicants receive consideration for employment without regard to age, race, ethnicity (including but not limited to hair texture and protected hairstyles), ancestry, color, sex, national origin, sexual orientation, gender, gender identity, gender expression, transgender status, religious creed, physical or mental disability (including actual or perceived disability), medical condition (including HIV/AIDS), pregnancy, perceived pregnancy and pregnancy related conditions, genetic information, marital status, political affiliation or activities, status as a victim of domestic violence, assault, or stalking, veteran status or participation in the uniformed military services of the United States, including the National Guard, or any other basis prohibited by applicable law.

Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed. 

Submit your resume to apply!

Science 37’s Nursing Solutions Group brings together expert nurses who share a passion for organizing, planning and implementing mobile clinical nurse services to participants in clinical trials. Science 37’s extraordinary work environment allows continuous collaboration between clinicians, clinical researchers, patient recruitment specialists, data managers and technology developers. The Nursing Solutions Group is involved throughout the trial life cycle, from protocol development and feasibility analysis to clinical trial implementation and closeout.

The Per Diem Mobile Research Nurse is a Registered Nurse who will work per diem and has experience across multiple therapeutic areas with the ability to work independently and integrate well with the Nursing Solutions Group. With interest/expertise in Science 37’s decentralized model of care delivery, the Mobile Research Nurse will perform delivery of care to participants as well as collaborate with brick and mortar sites, if indicated, for shared clinical trial implementation. The Mobile Research Nurse ensures the professional delivery of patient care in compliance with all federal and state regulations, Good Clinical Practice, and Standard Operating Procedures. 

*This is a travel role that requires on-site visits to participants homes.

Duties for this position include but are not limited to:

1. Participate and provide research nurse services to qualified study participants at home
2. Apply clinical research and nursing practices to develop solutions to complex problems
3. Collaborate with Lead and Per Diem Mobile Research Nurses on solutioning, education, and resource support
4. Participate in activities that will further the operational development of Science 37 nursing service delivery
5. Develop relationships with study team members and serve as the subject matter expert (SME) on all nursing processes
6. Other duties as assigned as the needs of Science 37 evolve and change

This position has the following qualifications:

1. BSN degree preferred
2. Full Covid Vaccination strongly preferred. Science 37 follows CDC guidelines for vaccination recommendations and such guidelines are subject to change.
3. Active RN licensure in home state as well as eligibility for Compact Licensure required
4. Minimum 2+ years clinical/research experience preferred
5. Basic Life Support (BLS) Certification
6. Maintain a positive reflection of the company by representation in participant’s homes or in clinic settings
7. Travel and availability qualifications are as follows:
   1. 1-2 days minimum a week dedicated to support Science 37's study visits
      1. Weekday/night availability required
   2. Must be willing to travel to a participants homes 
   3. Active Driver’s License

Science 37 is looking for people with the following skills and competencies:

1. BSN degree preferred
2. Active RN licensure in home state as well as eligibility for Compact Licensure required
3. Minimum 2+ years clinical/research experience preferred
4. Basic Life Support (BLS) Certification
5. Active Driver’s License
6. Weekday/night availability required
7. Maintain a positive reflection of the company by representation in participant’s homes or in clinic settings
8. Up to 100% travel, as needed, for study participant visits, project team meetings, and other professional meetings/conferences as needed
9. Ability to obtain nursing license in multiple states based on study needs
10. Physical ability to perform nursing tasks and lift equipment up to 15 kg in weight
11. Access to a reliable vehicle to perform study participant visits and transport equipment
12. Ability to drive to local and/or remote locations to perform study participant visits
13. Ability to use technology effectively and appropriately for study participant assessments and documentation including but not limited to study participant care equipment, laptop computers, communication devices and tablets
14. Ability to communicate in English (both verbal and written)

There is minimal supervision for this position, with individuals reporting to the Manager, Nursing Solutions Group.

Compensation varies based on location and work being performed. The starting pay range for a candidate selected for this position is generally within the range of $50-55 per hour. Employees may be eligible for additional discretionary bonuses and commissions. The successful candidate’s actual pay will also be based on qualifications and experience, so the actual starting pay may be above or below this range.

Science 37 is an equal opportunity employer.  

We are committed to creating a diverse environment and is an equal opportunity employer. All qualified applicants receive consideration for employment without regard to age, race, ethnicity (including but not limited to hair texture and protected hairstyles), ancestry, color, sex, national origin, sexual orientation, gender, gender identity, gender expression, transgender status, religious creed, physical or mental disability (including actual or perceived disability), medical condition (including HIV/AIDS), pregnancy, perceived pregnancy and pregnancy related conditions, genetic information, marital status, political affiliation or activities, status as a victim of domestic violence, assault, or stalking, veteran status or participation in the uniformed military services of the United States, including the National Guard, or any other basis prohibited by applicable law.

Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed. 

Submit your resume to apply!

How We Work Together

• Location: This is an on-site position with regional commute requirements
  • Travel: This role requires up to 10% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives. 
    • Type of travel required: ​Regional (within 100 miles)​ 
  • Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
    
    • Walking - 20%
    • Standing - 20%
    • Sitting - 20%
    • Lifting - 20%
      • Up to 25lbs
      • Over 25lbs Overhead
    • Driving - 20%

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

Position Summary

The Associate Director will collaborate with the Clinical Data Management team by providing leadership and knowledge.  Assists the head of Data Management in directing the design, documentation, testing and implementation of clinical data collection studies, and clinical database reviews in support of company objectives.  Ensures that the data management systems are business ready and of appropriate quality to fulfill those objectives.  Focuses on the oversight of quality data deliverables within Acadia Data Management and projects with Contract Research Organizations (CROs).

Primary Responsibilities

• Participates in the collaboration and coordination with others to design and implement clinical protocols and data collection systems.
• Assists in identifying and resolving data management issues on assigned studies.
• Responsible for ensuring data management timelines are met within assigned studies, in-house or outsourced.
• Provides strategic input into protocol design focused on data management portions.
• May assist Biostatistics in development/review of Statistical Analysis Plans.
• Reviews and resolves data discrepancies for standardized data validation systems and procedures, when applicable.
• Supports data management requirements and deliverables for New Drug Application (NDA)/Marketing Authorisation Application (MAA), including integrated databases. 
• Aids in production of quality data deliverables to support regulatory submissions, publications and due diligence activities.
• Reviews clinical, regulatory and other documents, as needed, to assure data integrity and quality.
• Oversees projects that have been engaged with CROs, as well leads and manages internal projects.
• Oversees and manages final data management electronic Trial Master File (eTMF) for assigned studies.
• Assists with the development of standards and process documentation, including Standard Operating Procedures and Work Instructions.
• Assures compliance with industry quality standards, guidelines and procedures.
• Assists in the selection and evaluation of new personnel to ensure the efficient operation of the function.
• May assist in the career development of Data Management personnel.  Position may have direct reports. May assist with input into corporate and department budget process and management.
• Other responsibilities as assigned.

Education and Experience

• Bachelor’s degree in Life Sciences, Mathematics or related field.  Targeting 8 years of progressively responsible experience within the pharmaceutical, biotech or CRO industry.  An equivalent combination of relevant education and experience may be considered.
• Previous experience in data management from protocol concept through database lock and clinical study report finalization.
• Knowledge of medical terminology.
• Knowledge of coding dictionaries (Medical Dictionary for Regulatory Activities -MedDRA, WHO Drug)
• Excellent verbal and written communication skills as well as interpersonal and organizational skills
• Proficiency in MS Office applications.
• Proficiency with data management systems and supporting statistical programs (e.g., SAS),
• Knowledge of database design and database concepts.
• Skilled at cross-functional/department communications to gain cooperation of others.
• Proven skill at effectively leading a cooperative team effort and organizing resources to achieve team goals.
• Able to make and prioritize process and resource decisions based on overall team needs.
• Must be able and willing to travel on occasion.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HYBRID #LI-SL1

Seeking talent near: Princeton, NJ ; San Diego, CA

Position Summary

The Associate Director in the Early Stage Drug Product Development organization at Acadia is responsible for the development of pharmaceutical formulations primarily intended for early-stage clinical trials and preclinical animal studies. This role also supports drug discovery teams by assisting in the selection of optimal drug candidates through detailed physicochemical characterization and assessment of compound properties. The incumbent will focus on formulation strategies tailored to early development phases, ensuring that candidates are suitably prepared for initial safety and efficacy evaluations. Additionally, collaboration with research scientists and external partners is essential to address technical challenges and advance promising compounds toward clinical readiness.

The incumbent will be responsible for management of activities relating to the above at the Contract Service Providers (CSPs) and will contribute both internally and externally in resolution of complex technological issues The role will be critical in ensuring that we select developable drug candidates, reduce risk and accelerate the introduction of new chemical entities into the Acadia pipeline.

Primary Responsibilities
 

• Designs and develops pharmaceutical formulations to support early stage clinical trials, providing acceleration options such as on-site compounding and impromptu type of drug products.
• Evaluate and validate new drug product CSPs (Contract Service Providers) to support development, oversee operations at existing suppliers.  Initiate and manage supplier contract agreements as necessary.
• Coordinate and supervise the development of clinical formulations and finished dosage forms at CSPs.  Serves as person-in-the plant at the CSP sites.
• Plans project-related scientific and technical activities, e.g. interpretation of results, evaluation of data, formulates relevant and scientifically based conclusions, writes and presents technical reports.
• With Translational Sciences teams, plans conduct of preclinical and toxicological studies and develops requisite formulations for the same considering developability of the new drug candidates.
• Develops phase appropriate formulations for new drug candidates in FIH, Phase 1 and POC studies employing resource sparing approaches such as compounded formulations and/or on-site preparations.
• Conduct physicochemical characterizations of the new drug candidates to support developability assessments.
• Authors and reviews technical reports and documents suitable for regulatory submissions. Reviews MBRs, BPRs, development reports and relevant documents prepared by CSPs.
• Liaises with the CMC team, late-stage formulation team, and formulation development management to establish the development strategy for formulation of the new drug candidates.
• Adheres to cGMP work practices and works closely with the Quality Assurance to ensure strict compliance with applicable GXP procedures and compliance requirements. Collaborates with regulatory teams in preparation of the health authority submissions for the early clinical trial applications (e.g. IND, CTA, IMPD)
• Other responsibilities as assigned.

Education/Experience/Skills

Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field. An equivalent combination of relevant education and applicable industry experience may be considered.  A minimum of 10 years’ experience in progressively responsible roles in formulation and manufacturing process development with some experience in leadership role desired.  Demonstrated success in the field of formulations and dosage form development.   Experience authoring technical reports and CMC sections for regulatory filings. 

Must possess:

• Comprehensive understanding of the physicochemical characterization of new drug candidates to assess developability, formulations for early stage clinical studies, and dosage form formulation and package development.
• Extensive knowledge of cGMPs.
• Skilled at managing CSPs.
• Demonstrated verbal and written communication skills.
• Adept at effectively aligning resources across multiple functional areas to achieve functional area goals.
• Flexibility to travel 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 to domestic and international locations is required.

#LI-HYBRID #NC1 

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

Seeking talent near: Princeton, NJ ; San Diego, CA

Position Summary

The Associate Director, Vendor & Relationship Management will support and optimize strategic partnerships with clinical vendors, CROs, and functional service providers to ensure operational excellence, compliance, and value delivery across global clinical development programs. This role will drive vendor governance, performance management, and continuous improvement initiatives while collaborating cross functionally to support R&D business objectives and foster a culture of partnership and innovation.  The Associate Director will partner closely with R&D stakeholders, Procurement, Quality, Finance, and Legal to enable effective vendor oversight and consistent outsourcing practices across the Acadia R&D organization.

Primary Responsibilities

Vendor & Relationship Management

• Support the development and execution of vendor and supplier relationship management strategies, including identification and management of critical partners (CROs, central and specialty labs, functional service providers, clinical technologies, patient recruitment and retention vendors).

• Serve as a primary point of contact for vendor related operational issues, coordinating resolution and escalating unresolved matters through established governance pathways.

• Coordinate and facilitate, when appropriate, vendor governance, including operational and steering committee meetings.

• Develop and maintain supplier scorecards, dashboards, and KPIs to monitor vendor performance and identify trends and risks.

• Conduct routine business reviews with vendors to ensure alignment on priorities and performance expectations, partnering with Sourcing and Legal as needed.

Operational Oversight & Excellence

• Oversee vendor performance supporting outsourced clinical trials, through partnership with the Clinica Operations team. Ensure alignment with program timelines, budgets, and quality expectations.

• Partner with Clinical Operations, Clinical Supply Chain, Quality, Finance, and other cross functional teams to support timely and compliant delivery of services.

• Support inspection readiness activities, including audits, vendor oversight documentation, and CAPA development in collaboration with Quality.

• Contribute to process mapping, documentation, and implementation of standardized vendor oversight practices.

Innovation & Continuous Improvement

• Identify opportunities to improve vendor performance, efficiency, and collaboration through data driven insights and process improvements.

• Support innovation initiatives within vendor relationships, including new operating models, technologies, or ways of working.

• Contribute to the development and rollout of best practices, standards, and tools for R&D vendor management.

• Identify opportunities for cost optimization, demand management, and improved vendor utilization.

Data, Reporting & Technology Enablement

• Support the development and maintenance of vendor performance reporting and dashboards.

• Analyze performance metrics to proactively identify risks, issues, and opportunities for improvement.

• Partner with internal teams to support implementation and optimization of vendor management tools and systems.

• Act as a mentor and subject matter resource for team members and matrixed stakeholders involved in vendor oversight.

• Foster strong, collaborative relationships with internal stakeholders and external partners to enable transparent communication and proactive issue resolution.

• Effectively influence stakeholders across a matrixed organization without direct authority.

• Other responsibilities as assigned.

Education/Experience/Skills

Bachelor’s degree in life science or a related field; Advanced degree preferred.  Targeting 8 years of experience in clinical trial operations, vendor/CRO oversight, supplier relationship management, or related roles within the biopharmaceutical industry.  Experience managing complex vendor relationships and supporting performance improvement initiatives required.  An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Strong understanding of clinical trial operations and outsourced service models.

• Working knowledge of ICH GCP, regulatory requirements, and quality expectations for outsourced clinical activities.

• Strong analytical skills, including experience with supplier scorecards, KPIs, and performance dashboards.

• Experience in R&D outsourcing, vendor governance, or business operations functions.

• Exposure to financial management of outsourced services, including budgeting and accruals.

• Experience supporting audits, inspections, or inspection readiness activities.

• Familiarity with alliance or partnership management methodologies.

• Excellent communication, interpersonal, and organizational skills.

• Ability to work effectively in a fast paced, matrixed environment while managing multiple priorities and working cross-functionally.

• Willing and able to travel both domestically and internationally.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HBRID #NC1

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

Position Summary

This role is responsible for supporting Clinical Operations’ management objectives to perform clinical trials that are of high quality, and that are delivered to agreed timelines and budget. This role manages clinical operations processes including project planning, budget, resource management, and contract research organization management. This role serves as a key contact and resource for Clinical Study Managers, CRA’s and Clinical Trial Assistants. Responsible for ensuring that clinical studies are carried out and delivered according to GCP and company SOPs. Assists with the creation and implementation of policies. Works cross-functionally to ensure that the teams provide required inputs and receive updates to carry out clinical trials in an effective manner.

Primary Responsibilities

· Manages clinical operations teams and represents clinical operations on multi-function projects teams, internally/externally. Works with clinical investigators, other roles, and Clinical Service Providers (CSP) to develop, execute, and deliver clinical studies/programs that are of high quality.

· Ensures quality delivery of study enrollment within agreed budgets and timelines.

· Participates in the design/review of clinical protocols, case report forms, tools and tracking systems, and IXRS systems.

· Develops and manages relationships with critical and non-critical 3rd party vendors and clinical site staff; maintains ongoing documentation, performs risk analyses, and may participate in due diligence and audit reviews.

· Effectively communicates project status and issues to management and the team.

· Prepares/oversees the preparation of all applicable documents required for the conduct of the study (Project Plan, Risk Management Plan, Monitoring Plan, Trial Master File (TMF)) etc.

· Manages and reviews the work of Contract Research Organization (CRO) to ensure that tasks are performed to scope and budget.

· Liaises with other functional groups to ensure that timelines, budgets, and study objectives are met.

· Liaises closely with Clinical GCP group to ensure that quality metrics are met throughout a trial.

· Oversees clinical study budgets.

· Provides day-to-day direction to Study Managers and Clinical Trial Assistants to carry out their work.

· Ensures compliance with good clinical practices (GCP), good documentation practices (GDP), and regulatory guidelines.

· Recommends and implements innovative process ideas to positively impact clinical trials management.

· Other responsibilities as assigned.

Education/Experience/Skills

Bachelor’s degree in life sciences or related field. Targeting 8 years’ progressively responsible pharmaceutical experience with a focus on clinical trials and late phase development. Leadership experience and CNS therapeutic experience preferred. An equivalent combination of relevant education and applicable job experience may be considered.

Key Skills:

· Knowledge and understanding of Good Clinical Practices (GCP) and other Clinical Trials Regulations and guidelines.

· Experience developing clinical protocols, Standard Operation Procedures (SOP), Clinical Study Reports, and other documents to support New Drug Application (NDA).

· Demonstrated ability to successfully develop, implement, and manage clinical trials.

· Practical experience in clinical trial strategies, methods, and processes; knowledge of clinical trial design.

· Demonstrated technical, administrative, and project management capabilities.

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

· Proficient computer skills, including Microsoft Word and Excel.

· Skilled at negotiating with business partners or management and influencing leaders regarding matters of significance to the department or segments of the organization.

· Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals.

· Ability to manage multiple priorities and work cross-functionally in a fast-paced environment.

· Must be willing and able to travel both domestically and internationally.

#LI-HYBRID #LI-CA1

Please note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Director of Drug Safety & Pharmacovigilance is a medical safety expert within the Drug Safety & Pharmacovigilance (PV) function, reporting to the Executive Director of Medical Safety. This role serves as the primary medical safety resource for assigned products across the Acadia portfolio, providing hands-on medical evaluation of safety data, signal detection and assessment, and clinical oversight of pharmacovigilance activities throughout the product lifecycle. The Director contributes product-level medical input to cross-functional safety governance, collaborates with the Executive Director of Medical Safety on complex or escalated safety issues, and supports regulatory submissions and health authority interactions for assigned products. 

Primary Responsibilities

• Serves as the primary medical safety resource for assigned Acadia products, providing product-level clinical safety and pharmacovigilance expertise across all stages of development and post-marketing surveillance
• Performs medical evaluation and interpretation of aggregate safety data for assigned products, including signal detection and evaluation, ad hoc safety assessments, and benefit-risk analyses; escalates complex or novel safety issues appropriately
• Assesses safety signals and trends for assigned products and proactively manages potential safety issues in collaboration with cross-functional stakeholders
• Contributes product-level medical input to the Medical Safety team and other cross-functional safety governance bodies
• Performs medical review of all serious adverse events from Acadia clinical trials for assigned products
• Performs retrospective medical review of adverse events for post-marketed products
• Authors Analysis of Similar Events (AOSE) and individual case narratives and comments for ICSRs for assigned products
• Provides oversight for the safety aspects of clinical studies for assigned products, including development and maintenance of product-specific core safety information
• Reviews and approves safety sections of clinical documents for assigned products, including protocols, DSURs, final study reports, and other documents as required
• Formulates response strategies and authors health authority responses for safety-related queries pertaining to assigned products, in collaboration with the Head of Medical Safety
• Provides medical input into Periodic Benefit Risk Evaluation Reports (PBRERs) for assigned products, including clinical interpretation of safety data
• Provides medical and scientific input into Risk Management Plans (RMPs/dRMPs) and REMS programs for assigned products
• Ensures all PV Medical Safety activities for assigned products are performed in compliance with applicable regulations and Acadia standards
• Maintains current knowledge of global regulatory authority regulations and guidance
• Other responsibilities as assigned

Education/Experience/Skills

• MD (Doctor of Medicine) or equivalent medical degree from an accredited institution, with relevant postgraduate clinical training and experience; candidates who are eligible for U.S. medical board certification are preferred. MPH or pharmacoepidemiology training is a plus. 
• 6 to 7 years of relevant drug safety experience, including expertise in safety signal management (signal detection, evaluation, aggregate data review, ICSRs), preferably in a pharmaceutical or biotech environment.  
• Neurology, psychiatry, rare disease, or CNS-related therapeutic area experience strongly preferred
• Advanced knowledge of FDA, EU, and ICH regulations and guidelines related to pharmacovigilance, including clinical trial safety monitoring, post-marketing surveillance, ICSR processing, aggregate reporting, and health authority reporting requirements
• Ability to assess product benefit-risk profiles and interpret clinical and post-market safety data
• Demonstrated expertise in safety signal detection methodologies and medical evaluation of aggregate safety databases
• Ability to author and critically review regulatory safety documents (DSURs, PBRER safety sections, health authority responses)
• Strong analytical and critical decision-making skills; ability to manage competing priorities and meet deadlines with minimal oversight
• Experience with pharmacovigilance safety databases (Argus) and signal detection tools
• Familiarity with pharmacoepidemiology concepts and study design
• Excellent interpersonal, written, and oral communication skills; ability to effectively communicate complex safety findings to internal and external stakeholders
• Proficiency in MS Office Suite (Word, PowerPoint, Excel)
• Ability to manage multiple priorities and work cross-functionally in a fast-paced environment
• Must be willing and able to travel both domestically and internationally

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HYBRID 

Seeking talent near: Princeton, NJ

Position Summary

The Associate Director, Drug Product Development is responsible for the formulation, primary package, and manufacturing process development for Acadia’s growing portfolio of drug candidates at all stages of development, and will provide technical oversight, expertise and guidance of externalized drug product development related activities. The scope includes development of formulations, package, and process for all modes of administration including oral solid, liquid, and injectable dosage forms for candidates ranging from clinical development to process validation and life cycle management. The incumbent will be responsible for management of activities relating to the above at the Contract Service Providers (CSPs) and will contribute both internally and externally in resolution of complex technological issues and implementation of new manufacturing process technology for products intended for clinical and commercial distribution. The role will be critical in ensuring that we optimize development, reduce risk and accelerate the development of new assets for commercialization.

Primary Responsibilities

• Designs and develops pharmaceutical formulations and manufacturing processes to support clinical trials, registration and product launch.
• Evaluate and validate new drug product CSPs (Contract Service Providers) to support development, scale up, and commercialization of the new drug candidates in the Acadia pipeline.  Initiate and manage supplier contract agreements as necessary.
• Coordinate and supervise the development, scale-up to manufacturing of clinical formulations and finished dosage forms at CSPs.  Serves as person-in-the plant at the CSP sites.
• Plans project-related scientific and technical activities, e.g. interpretation of results, evaluation of data, formulates relevant and scientifically based conclusions, writes and presents technical reports.
• Review the clinical supply requirements with the clinical supply managers and plan requisite manufacturing schedule with the CSPs to ensure uninterrupted supply of clinical trial materials.
• Perform risk assessments of manufacturing process and product at key development milestones and address the findings with the relevant CSPs.
• Authors and reviews technical reports and documents suitable for regulatory submissions. Reviews MBRs, BPRs, development reports and relevant documents prepared by CSPs.
• Liaises with analytical, manufacturing, quality assurance and regulatory counterparts to develop plans and protocols for drug product development and for life cycle management of the established products.
• Adheres to cGMP work practices and works closely with the Quality Assurance to ensure strict compliance with applicable GXP procedures and compliance requirements. Assist the CSPs in preparation for health authority inspections and for pre-approval inspections.
• Other responsibilities as assigned.

Education and Experience

• Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field. An equivalent combination of relevant education and applicable industry experience may be considered.
• A minimum of 10 years’ experience in progressively responsible roles in formulation and manufacturing process development with some experience in leadership role desired.
• Demonstrated success in the field of formulations and dosage form development.  
• Experience authoring technical reports and CMC sections for regulatory filings. 

Must possess:

• Comprehensive understanding of the dosage form formulation and package development, manufacturing process development, scale-up, optimization and validation processes.
• Extensive knowledge of cGMPs.
• Skilled at managing CSPs.
• Demonstrated verbal and written communication skills.
• Adept at effectively aligning resources across multiple functional areas to achieve functional area goals.
• Flexibility to travel domestically and internationally.

#LI-HYBRID #NC1

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.

Key Duties and Responsibilities 

Collaborate with global clinical teams (Clinical Operations, CMC, Quality Assurance, Regulatory, etc.) and network of Clinical Development and Manufacturing Organizations to oversee end-to-end supply chain activities from phase 1-3 and IIT trials. Leads and manages clinical packaging and labeling operations / Investigational Drug, Standard of Care Drug and Medical Devices, drive clinical label creation and approvals process, including translations for applicable countries. Lead end-to-end supply chain network set-up for new and upcoming global clinical trials. Develop Supply Strategies and Inventory optimization plans per program, protocol design and region. Design, Implementation and UAT of Interactive Response Technology (IRT/IxRS) for multi-arm drug-device combination trials. Develop, implement, and update Supply Chain SOPs and Work Instructions. Co-develop device and pharmacy manual. Manage Temperature excursions, CAPA, SCARs and other quality events as applicable. Supplier Management: Standard of Care Drug Procurement, RFQ, Vendor Management, Cost saving initiatives, Negotiations, Supplier relationship/evaluation. Quarterly review of budgets vs actual spend for active studies. Provide Supply Chain support for regulatory filings including IND submission information, Import/Export Licenses filing and audits from all health agencies. Proactively report supply risk, product and material availability issues. Participate in and contribute to supply chain metrics, S&OP (Sales & Operations Planning) process. Drive Ad-hoc projects to review exceptions/changes relating to Supply Chain. This position is open to telecommuting from anywhere in California. Requires occasional presence in office. Travel required. As needed, up to 15% travel covering global  Supply Chain areas for Supply Chain Management, Clinical & Commercial Supply Chain, Manufacturing & Production Planning, and other related activities.

Requirements

Master’s degree or foreign equivalent in Supply Chain Management, Industrial, Operations, Production engineering or closely related degree and experience as an Associate Manager, Technical Operations & Supply Chain, Supply Chain Specialist, Clinical Supply Chain Coordinator or related occupation in supply chain management. APICS/ASCM Certification required (CPIM or CTL or CSCP).

Desired Education, Skills and Experience

Experience must include four (4) years of experience in all of the following:

1. Experience in global clinical supply chain management, medical device industry and developing/implementing clinical trial management technologies (eg: IxRS, IRT, etc.).
2. Experience in forecasting, supply planning, optimizing inventory, S&OP process, scenario planning, production planning & scheduling, CMO management, regulatory requirements relating to clinical labeling, packaging, and distribution activities.
3. Working under a highly regulated cGMP and GCP manufacturing environment.
4. Designing and setting up complex supply chain networks within strict FDA compliance, GLP, GCP and GDP frameworks.

Or an alternative Bachelor’s degree or foreign equivalent in Science in Supply Chain Management, Industrial, Operations, Production Engineering or a closely related degree and experience as an Associate Manager, Technical Operations & Supply Chain, Supply Chain Specialist, Clinical Supply Chain Coordinator or related occupation in supply chain management. APICS/ASCM Certification required (CPIM or CTL or CSCP).                                

Experience must include six (6) years of experience in all of the following:

1. Experience in global clinical supply chain management, medical device industry and developing/implementing clinical trial management technologies (eg: IxRS, IRT, etc.).
2. Experience in forecasting, supply planning, optimizing inventory, S&OP process, scenario planning, production planning & scheduling, CMO management, regulatory requirements relating to clinical labeling, packaging, and distribution activities.
3. Working under a highly regulated cGMP and GCP manufacturing environment.
4. Designing and setting up complex supply chain networks within strict FDA compliance, GLP, GCP and GDP frameworks.

Salary: $149,282.00 annually

Job Requisition #277

Opened: 08 APR 2026

Position

As a Senior Medical Writer 2, you will play a pivotal role in translating complex scientific and medical information into clear and concise written materials. Operating in a dynamic and collaborative environment, you will contribute to the development of various documents that support our research, clinical trials, and regulatory activities.

About You 

The ideal candidate for this position should possess strong writing and communication skills, with the ability to effectively convey complex scientific concepts in a clear and concise manner. Exceptional attention to detail and a commitment to producing accurate and high-quality written materials are essential. Proficiency in Microsoft Office Suite and familiarity with scientific writing tools is important, and the candidate should be capable of thriving in a fast-paced and collaborative work environment. While knowledge of clinical research, regulatory requirements, and biotechnology is advantageous, it is not required.

What You’ll Do

• Document Preparation: Create a wide range of medical and scientific documents, including clinical study protocols, investigator brochures, regulatory submissions, and scientific publications.
• Content Development: Collaborate closely with cross-functional teams to collect and interpret data, ensuring accuracy and relevance in written materials.
• Regulatory Compliance: Ensure that all written materials strictly adhere to regulatory guidelines, industry standards, and internal quality standards.
• Literature Review: Conduct comprehensive literature reviews to support the development of evidence-based documents.
• Data Interpretation: Proficiently interpret and summarize complex scientific data and clinical trial results for various audiences.
• Editing and Proofreading: Review and edit documents for grammar, clarity, and consistency while maintaining a high level of accuracy.
• Collaboration: Collaborate closely with scientists, clinical teams, and regulatory affairs professionals to align written materials with project goals and timelines.
• Mentorship: Provide guidance and mentorship to junior medical writers, fostering their professional growth and development.

Qualifications

• PhD with 3 years of experience or a Master’s degree with 6 years of experience or a Bachelor's degree with 8 years of experience in a relevant field (e.g., life sciences, healthcare, or related discipline). 
• Strong writing and communication skills, with the ability to effectively convey complex scientific concepts in a clear and concise manner.
• Must have hands on experience with independently drafting CSRs, ICFs, IBs, Protocols, and/or CTD modules
• Exceptional attention to detail and commitment to producing accurate and high-quality written materials.
• Proficiency in Microsoft Office Suite and familiarity with scientific writing tools.
• Capability to thrive in a fast-paced and collaborative work environment.
• Knowledge of clinical research, regulatory requirements, and biotechnology is advantageous but not required.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $148,000 to $161,500 depending on skills, competency, and the market demand for your expertise.

Position: 

The Associate Director, Clinical Data Analytics and Reporting is a leader responsible for establishing and scaling a Clinical Research & Development clinical analytics function for a growing biotechnology company. This role will define the analytics strategy, operating model, and technology roadmap, including the technical implementation to enable high-quality, data-driven decision-making across Clinical Research & Development, with primary focus on oncology programs.  This is a hands-on role requiring demonstrated expertise in design, development, test and support of complete analytics & reporting system lifecycle. This leader will partner closely with Clinical Operations, Biostatistics, Data Management, Clinical Research, Regulatory, Safety and Clinical Quality Assurance to ensure proactive risk identification, operational excellence, inspection-ready execution across the portfolio. 

About You 

The successful candidate will combine deep clinical development expertise with advanced analytics, data governance, and visualization capabilities. The ideal candidate for this role should possess a proven track record of designing, implementing and supporting end-to-end data analytics solutions using current state-of-the-art technologies, and a deep knowledge of emerging trends and best practices in data analytics.  

What will you do: 

• Collaborate with Stakeholders in different areas of Clinical Development R&D organization, IT System Owners and external vendors to define and implement the clinical analytics vision, strategy and capabilities (e.g., dashboard, etc.) aligned with clinical development objectives. 
• Establish a scalable analytics operating model suitable for early stage through late phase development.
• Translate complex clinical and operational data into clear, actionable insights for executive and study teams (including predictive and prescriptive analytics to anticipate risks and optimize trial execution).
• Design, development, test and deployment of the complete end-to-end analytics solution to enable decision-grade dashboards and metrics across Clinical R&D.
• Design and implementation of datawarehouse/datalake/lakehouse including star schemas.
• Collaborate with System Owners, Business Owners and Subject Matter Experts to map sources system objects and attributes to data warehouse objects.
• Develop, test and support data pipelines for extract, transform, load (ETL) of the source system data to populate datawarehouse/datalake/lakehouse.
• Develop end user facing dashboards and analytics solutions.
• Support the operations of the IT systems landscape ensuring system uptime, ETL and other job completion as per schedule, ongoing system changes and enhancements. 

Qualifications 

• Post Graduate degree with 8+ years of experience or a Bachelor’s degree with 10+ years of experience in development and support of Clinical Operations analytics solutions.
• Demonstrated strong experience working with developing end user dashboards using solutions such as Qlik, Power BI, Shiny R/Python.
• Strong Experience developing datalake/lakehouse solutions on platforms such as Snowflake, Databricks, AWS, and Azure.
• Strong working knowledge of development and management of database technologies such as Postgres, SQLServer etc.
• Experience with development of data pipelines including ETL from source systems to datawarehouse/datalakes/lakehouse using solutions such as Apache Airflow, Fivetran, dbt etc.
• Excellent oral and written communication skills with high EQ to effectively collaborate with business cross-functional teams.
• Understanding of the clinical development lifecycle and demonstrated experience building analytics capabilities in clinical development
• Knowledge of Report/Dashboard development in Veeva R&D Vaults such Clinical, RIM, Quality, Safety is preferred.
• Knowledge of IT Computer System Validation (CSV) in a GxP environment is preferred.
• Experience with Automation and AI Agent Frameworks is preferred.
• Deep knowledge of RBQM, Quality by Design (QbD) and regulatory/operational expectations for clinical oversight is preferred. 

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $191,000 to $209,000 depending on skills, competency, and the market demand for your expertise.

Position

The Associate Director, Clinical Study Management, will be responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas, as required. The successful candidate will work closely with cross-functional Clinical Research & Development teams to ensure successful completion of studies within timelines and budget, with a focus on exquisite quality to support operational excellence and world class inhouse clinical study management.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

About You

You are collaborative, solutions oriented, flexible and have global clinical operational experience, with a passion for excellence in advancing patient care in oncology.

What You’ll Do

• Team leader and builder, who manages clinical trial deliverables, timelines, and budgets per the Clinical Development and Operational Plans
• Works with minimal oversight from the Clinical Operations Senior Director or Director, in collaboration with Clinical Study Management teams and Clinical Research and Development functional teams
• Demonstrate broad understanding of therapeutic and clinical drug development expertise to influence study design and program-level decisions 
• Provide direction to cross-functional study teams to ensure successful study execution Ensure that clinical studies are conducted  following approved protocols, FDA Regulations, ICH-GCP, EMA, PMDA, other relevant regulations, directives, and guidelines, and company procedures and quality documents
• Oversee risk identification, assessment, and mitigation strategies to ensure patient safety and data integrity
• Responsible for the implementation of processes and systems that will facilitate inspection readiness throughout the lifecycle of the trial.
• Oversee the preparation and maintenance of detailed clinical trial project timelines
• Manage ancillary (non CRO) vendor relationships and performance to ensure that clinical studies are completed following contract specifications of time, cost and quality.
• Work with finance, legal, and external vendors to ensure the assigned studies are meeting the target milestones
• Provide regular updates on study progress to stakeholders (e.g., Clinical Operations, Project & Portfolio Management, Clinical Research)
• Ensure that all study-related documents are accurate, complete, timely and filed appropriately in all clinical (Veeva TMF), regulatory, safety and finance systems.
• Responsible for hiring, performance management, career development, and providing mentorship to Clinical Study Management personnel.
• Contribute to initiatives and projects adding value to Eikon Therapeutics

Qualifications

• Minimum of 10 years of related experience with a Bachelor’s degree or 8 years and a post-graduate degree.
• Experience leading large, global clinical trials, preferably in oncology
• In-depth knowledge of ICH-GCP, EMA guidelines and other relevant regulations and guidelines.
• Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety.
• Strong leadership and communication skills, with a demonstrated ability to work collaboratively with cross-functional teams.
• Experience with management of the budget, resources, headcount, processes and controls, productivity, quality and project delivery.
• High sense of accountability and urgency to prioritize deliverables.
• Growth mindset and capable of working independently.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $183,000 to $199,500 depending on skills, competency, and the market demand for your expertise.

Position

The Clinical Program Manager, Oncology, Clinical Study Management, will plan and oversee the execution of clinical trials in oncology and other therapeutic areas, as needed. This role  works in close partnership with cross-functional teams to ensure studies are delivered on time and within budget, with a strong focus on quality,  operational excellence, and best-in-class clinical study management. The successful candidate will play a key role in driving study execution, managing risks, and enabling high-performance collaboration across functions and regions.

This role will require a minimum of 3 day a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. 

About You

You are collaborative, solutions oriented, flexible and have global clinical operational experience, with a passion for excellence in advancing patient care in oncology or neuroscience.

What You’ll Do

• Develop and own the operational strategy, timelines, and operational plans for clinical trials, ensuring alignment with program objectives and overall business goals.
• Oversee and lead cross-functional clinical trial execution, leading proactive risk identification, assessment, management, and driving alignment on mitigation strategies.
• Ensure high standards of quality by overseeing that clinical studies are conducted in accordance with approved protocols, company SOPs, applicable regulations, and maintain ongoing inspection readiness across the program lifecycle.
• Serve as central point of contact to facilitate cross functional team effectiveness, drive operational efficiency, and provide clear direction and guidance to ensure successful study execution.
• Work with minimal oversight from the Clinical Study Management Senior Director or Director, in collaboration with Clinical Study Management teams and Clinical Research and Development, Finance, and Legal functions.
• Oversee and manage vendor relationships and performance to ensure that clinical studies are completed in accordance with contractual specifications for quality, timelines, and cost.
• Provide regular, clear updates on study progress, risks, and mitigation plans to stakeholders and executive management (e.g., Clinical Study Management, Project & Portfolio Management, Clinical Research).
• Ensure that all study-related documents are accurate, complete, and filed appropriately in all clinical (Veeva TMF), regulatory, safety and finance systems in a timely manner.
• Lead, manage, hire, develop, and mentor global and regional Clinical Study Management personnel.
• Contribute to improvement initiatives, operational excellence efforts, and cross-functional projects that add value to Eikon Therapeutics.

Qualifications

• Bachelor’s degree with 8 years, a Master’s degree with 6 years, or a PhD with 3 years of relevant experience in life sciences, healthcare, or related field preferred. 
• Fluency in English (strong reading, writing, and speaking skills with the ability to effectively communicate with colleagues and stakeholders at all levels) is required.
• In-depth knowledge of ICH-GCP, regulations, directives, and guidelines.
• Proficiency in clinical trial management systems (CTMS, RTSM (IRT), Veeva Vault suite) and electronic data capture (EDC) systems.
• Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety.
• Strong leadership and communication skills, with a demonstrated ability to work collaboratively with cross-functional teams.
• Experience managing budgets, resources, processes and controls, productivity, quality, and project delivery.
• High sense of accountability and urgency to prioritize deliverables effectively.
• Growth mindset and ability to independently.
• PMP certification preferred.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $157,000 to $171,000 depending on skills, competency, and the market demand for your expertise.

Position

As a Clinical Trials Associate, APAC in Oncology, you will play a crucial role in supporting the planning, coordination, and execution of Phase I-III insourced global clinical studies within the oncology portfolio. Operating in a dynamic and collaborative environment, you will provide essential support for the execution of clinical trials, contributing to the development of groundbreaking therapies with the potential to transform patient lives.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City (NJ) or Millbrae (CA) offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

This position requires fluency in Mandarin, Cantonese, Japanese, or Korean candidates without this qualification will not be considered due to the nature of interacting with locally based trial sites in Asia. 

About You

You are passionate about playing a key role in supporting the planning, coordination, and execution of clinical trials within the oncology portfolio. You have strong communication skills and a passion for advancing care to patients.

What You’ll Do

• Assist in the preparation and maintenance of essential study documents, including study protocols, informed consent forms, case report forms (CRFs), and other trial-related materials
• Collaborate with cross-functional teams to ensure accurate and timely completion of study start-up activities, such as site selection, feasibility assessments, and ethics committee submissions
• Support the organization and conduct of investigator meetings, study initiation visits, and other trial-related meetings
• Coordinate and track the distribution, collection, and reconciliation of trial supplies, investigational products, and study related materials
• Assist in the review and resolution of data queries, ensuring data accuracy and completeness within electronic data capture (EDC) systems
• In collaboration with TMF Operations team, maintain trial master files (TMFs) and study documentation in accordance with regulatory requirements and internal SOPs
• Facilitate effective communication among study team members, investigators, and study site personnel through regular correspondence and timely dissemination of study-related information
• Support the monitoring and tracking of study progress, including patient recruitment and enrollment, to ensure adherence to study timelines and milestones
• In collaboration with other Clinical Operations groups (Site Engagement and Monitoring Excellence) assist, as necessary, in the preparation and coordination of site monitoring visits, ensuring compliance with monitoring plans and resolution of site-related issues
• Stay updated with relevant regulations, guidelines, and industry best practices pertaining to oncology clinical trials, ensuring compliance, and implementing necessary changes as required

Qualifications

• An Advanced Degree without experience or Bachelor's degree with 2 years of experience in a relevant field (e.g., life sciences, healthcare, or related discipline)
• Ability to communicate in multiple languages required.
• Previous experience working as a Clinical Trials Associate, Study Coordinator, or in a similar role within the pharmaceutical, biotechnology, or CRO industry is preferred
• Knowledge of clinical trial regulations, guidelines, and best practices, including ICH-GCP and FDA requirements
• Strong organizational skills and attention to detail, with the ability to manage multiple tasks and prioritize workload effectively
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems
• Excellent written and verbal communication skills, with the ability to effectively interact with study team members and internal / external stakeholders
• Ability to work independently as well as collaboratively in a team-oriented environment
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Project)
• Adaptability and willingness to learn and embrace new technologies, processes, and industry trends

The expected hourly range for this role is $50/hour to $54.80/hour depending on skills, competency, and the market demand for your expertise. This is a contract role, expected to last approximately 12 months, with an anticipated workload of 40 hours per week. 

Position

As a Clinical Trial Management Associate (CTMA), you will serve as a critical inhouse clinical operations partner in the execution, and oversight of Phase I–III global oncology clinical trials. Positioned between the Clinical Trial Associate (CTA) and Clinical Trial Manager (CTM), the CTMA brings increased ownership, autonomy, and judgment to the execution of clinical studies. You will independently manage assigned study responsibilities and help ensure the delivery of high-quality, compliant, and timely trial data in support of our mission to bring transformative therapies to patients.

This role requires a minimum of 3 days per week onsite (or more, as business needs require) in either our Jersey City (NJ), or Millbrae (CA) offices.

This position requires fluency in one of the following languages due to the nature of site interactions in various regions in EMEA or LATAM: Portuguese, German, Italian, French, Polish. 

About You

You bring a strong operational mindset, an ability to work independently, and a flexible and collaborative spirit. You are looking to grow beyond a CTA role and take on more direct responsibility for study deliverables, bringing with you valuable clinical research experience and a strong passion to contribute meaningfully to drug development through consistent operational excellence.

What You’ll Do

• Proactively support Clinical Study Management team members in the day-to-day execution of global clinical trials, with increasing independence and accountability for specific study components. Collaborate closely with assigned global (gCSM)/regional Clinical Study Management (rCSM) teams, ensuring operational excellence throughout study execution.
• Manage and coordinate critical study activities with minimal oversight such as site communications, and maintenance of study timelines, risk logs, and action trackers.
• Lead the coordination and execution of site start-up assigned activities across multiple countries, working closely with regulatory, study start-up, and site engagement and monitoring excellence inhouse teams.
• Independently maintain and oversee trial master file (TMF) quality and completeness, in collaboration with TMF Operations, ensuring inspection readiness at all times.
• Draft, review, and manage study documents such as monitoring plans, training materials, and site communications under the guidance of the CTM.
• Track and reconcile investigational product (IP) and clinical supply/lab shipments, proactively flagging discrepancies and collaborating with supply chain to resolve issues.
• Support site level budget tracking invoice reconciliation, and vendor communications in partnership with Clinical Operations and Finance.
• Coordinate and contribute to key study meetings (e.g., team meetings, vendor meetings, investigator meetings), including agenda development, meeting facilitation, and action item follow-up.
• Monitor enrollment and site performance metrics, contributing to analysis and mitigation strategies to meet enrollment goals and drive operational excellence.
• Partner with data manager lead to ensure timely site follow up (assigned sites) for query reconciliation to meet the study milestones (e.g., interim analyses goals, etc.).
• Ensure compliance with study protocols, SOPs, and regulatory guidelines (e.g., ICH-GCP, FDA) across all operational activities.

Qualifications

• Bachelor’s degree with 3+ years of relevant clinical trial experience or a Master’s degree with 1–2 years of experience.
• Demonstrated ability to work independently and manage multiple competing priorities with minimal oversight.
• Strong understanding of clinical trial processes and regulatory requirements (ICH-GCP, FDA).
• Experience using clinical systems such as CTMS, EDC, and eTMF; Veeva Vault experience is a plus.
• Excellent organizational and time management skills with high attention to detail.
• Strong written and verbal communication skills and ability to interact confidently with internal stakeholders and external partners.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Project).
• Previous oncology trial experience preferred but not required.
• Working experience in LATAM/EMEA

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $122,000 to $133,000 depending on skills, competency, and the market demand for your expertise.

Position 

We are seeking a talented, experienced, and highly motivated Clinical Trial Manager (CTM) to join our oncology Clinical Operations team. This role will require onsite presence a minimum of 3 days a week in our Millbrae, CA or Jersey City, NJ office to ensure effective global clinical trial management. The candidate must have the ability to work independently, be an effective leader, and an engaged clinical study team member in a dynamic, fast-paced environment.  You will play a key role in contributing to high quality in-house clinical study management, ensuring compliance with regulatory guidelines, and contributing to planning, managing and the successful completion of global clinical studies. 

This position requires proficiency in Mandarin, Cantonese, Japanese, or Korean and English (strong reading, writing, and speaking skills and an ability to effectively communicate with colleagues and stakeholders at all levels). 

About You 

You have strong communication skills and are a collaborative, agile, detail oriented trial leader with global trial experience, and you have a passion for operational excellence and advancing patient care for grievous diseases. 

What You’ll Do 

• In partnership with Clinical Study Management, provide guidance and daily oversight for the successful in-house management of all aspects of international in-sourced clinical trials, delivering high quality study data, on time and on budget 
• Develop and execute operational plans for the successful in-house implementation and management of oncology clinical trials 
• Collaborate with cross-functional teams, including data management, clinical scientists, regulatory and investigators, to ensure operational excellence and rapid delivery of high quality data. Ability to examine functional issues from a broader organizational perspective. 
• Manage all aspects of trial start-up activities, collaborating with other Clinical Operations functions (Site Engagement & Monitoring Excellence, and Supplier Relationship Management & Performance), to deliver efficient and effective site selection, feasibility assessments, and preparation of study-related documentation 
• Collaborate with other Clinical Operations functions (Site Engagement & Monitoring Excellence) to efficiently and effectively deliver study site initiation, training, and monitoring activities to ensure adherence to study protocols, regulatory requirements, and ICH-GCP guidelines 
• Collaborate with other Clinical Operations functions (Site Engagement & Monitoring Excellence) to develop and maintain strong relationships with investigators, study coordinators, and study site personnel to facilitate patient recruitment and retention 
• Monitor and evaluate study progress, identifying risks, issues, and deviations, and implement appropriate corrective actions to maintain study integrity and timelines 
• Ensure compliance with regulatory requirements, including ICH-GCP, FDA guidelines, and other applicable regulations throughout the trial lifecycle 
• As required, collaborate with external vendors, including CROs, central laboratories, and imaging providers, to ensure their efficient and effective deliverables to the trial 
• Contribute to the development and review of study-related documents, such as protocols, informed consent forms, case report forms (CRFs), and standard operating procedures (SOPs) 
• Prepare study materials and establish procedures to ensure adherence to study protocols and administrative requirements 
• Lead the creation and maintenance of all study files, including the study master file, and oversight of site files  
• Lead periodic review of the Sponsor Trial Master File

Qualifications 

• PhD and 3 years of relevant experience, or Masters Degree and 6 years of relevant experience, or Bachelors Degree and 8 years of relevant experience  
• Proven experience in Clinical Operations; Oncology trial management experience preferred 
• In-depth knowledge of clinical trial regulations, guidelines, and best practices, including ICH-GCP and FDA requirements, specific to oncology research 
• Demonstrated experience in managing and executing clinical trials from start-up to closeout 
• Strong project management skills, with the ability to effectively prioritize tasks, allocate resources, and manage study timelines and budgets 
• Excellent interpersonal and communication skills, with the ability to collaborate effectively with stakeholders at all levels, and create a clear sense of direction as necessary 
• Detail oriented with strong analytical and problem-solving abilities, capable of identifying and mitigating study risks and deviations 
• Proficiency in using Veeva clinical trial management systems (CTMS)  
• Understanding of oncology therapeutic areas, including familiarity with oncology treatment modalities, disease progression, and related medical terminology
• Ability to work onsite at least 3 days a week

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $130,000 to $142,500 depending on skills, competency, and the market demand for your expertise.

Position

We are currently seeking an experienced leader for the clinical operations role of Director Clinical Study Management & Operational Excellence within Clinical Study Management.  The Director will manage all aspects of clinical operations study management, for assigned Eikon clinical programs, and be responsible for exquisite inhouse execution of all interventional clinical trials and oversight of requisite clinical vendors. The role will also support the systematic pursuit of optimal performance, efficiency, and quality across all aspects of clinical study management via a focus on operational excellence. Adherence to Good Clinical Practice (GCP), local and global policies and procedures to conduct high quality, inspection ready studies is essential. The Director is responsible for trial quality and audit responses and completion of CAPAs. They will be a single point of contact for managing clinical trial operationally excellent execution in all its aspects across clinical study phases. The position has multiple stakeholder touch points within Clinical Research & Development (CR&D) staff and important interactions with, inter alia, Quality Assurance (QA), Finance, Regulatory, Clinical Supplies, Business Development and Legal in a matrix-based organization.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City, New Jersey or Millbrae, California offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth and collaboration.

About You

You are agile of mind, systematic, and a collaborative leader with global oncology clinical development experience and a passion for operational excellence and advancing patient care. You possess a deep understanding of clinical trial regulations, guideline, and the principles of GCP, ensuring compliance throughout the clinical trial process.

What You’ll Do

• In collaboration with senior clinical operations management, build and lead inhouse clinical operations study management teams responsible for operationally excellent delivery of assigned clinical protocols and programs.
• Manage clinical study management personnel across assigned clinical protocols and programs.
• Ensure that compliance, quality and timeline objectives are met for all assigned trials.
• Work collaboratively in a matrix organization with all internal stakeholders to deliver company clinical trial objectives on time, on budget and with high quality.
• Work with the CR&D Functional Area (FA) leads, as appropriate, in site management to accelerate enrollment and drive high quality.
• Take responsibility for any assigned clinical trial audits, working closely with the Clinical Quality Assurance group.
• Represent Clinical Study Management in operational excellence initiatives, in the systematic pursuit of optimal performance, efficiency, and quality across all aspects of clinical trial management and execution. Key components of operational excellence, in clinical study management, are: (1) quality and compliance, (2) process optimization, (3) technology integration, (4) risk management, (5) performance metrics, (6) cross-functional collaboration.
• Effectively solve problems and use judgment relating to national and international regulations, guidelines, investigator interactions and timelines.
• Effectively manage resources to ensure appropriately skilled and high performing staff members are assigned to support the effective execution of the portfolio and achieve CR&D objectives.
• Responsible for ensuring appropriate scientific and operational training for staff members.
• Serve as a talent magnet and develop, coach, and retain top talent in the clinical program team.
• Sets clear performance standards and holds self and organization accountable for achieving results with flawless execution.
• Embrace metrics and performance standards (KPIs) to drive continuous improvement in execution.

Qualifications

• A post-graduate degree with 12+ years of relevant experience with a Bachelor’s degree or 10+ years of relevant experience with a Master's Degree with a demonstrated working experience in clinical study management within the biotechnology, pharmaceutical, or healthcare industry. 
• Significant experience managing international clinical studies and programs in oncology.
• Proven track record of contribution to and delivery of clinical trials that support global regulatory submissions, clean regulatory inspections and product approvals or marketing authorizations.
• Significant management experience in a clinical trial setting with the ability to service and collaborate with different CR&D stakeholders in a matrix organization.
• Demonstrated situational leadership, independence, problem solving abilities, self-motivation, resourcefulness and ability to work in a fast-paced team environment.
• Significant management expertise should cover management of budget, resources, headcount, processes (and controls), productivity, quality and project delivery.
• A complete understanding of ICH GCP and Global/Regional/Local regulatory requirements is required.
• Strong communication skills requiring proficiency in written and spoken English.
• The incumbent must be competent and effective in written and verbal communication.
• Strategic thinking and high emotional intelligence.
• Strong operational excellence mindset and experience.
• Strong leadership that will attract, motivate, inspire, develop and retain talented staff.
• In addition, leadership skills that enable and drive alignment with the goals, purpose and mission of our company.

The expected hourly range for this role is $108.65 to $118.75 depending on skills, competency, and the market demand for your expertise.

Position 

We are seeking a highly experienced, collaborative, and detail-oriented Contract Senior Manager capable of helping Eikon optimize its clinical Site Engagement and Monitoring function to support delivery of world class clinical drug development. The successful candidate will work closely with the Eikon Site Engagement and Monitoring Excellence (SEME) team, global Clinical Research Associates (CRAs) and internal study teams across therapeutic areas to oversee clinical site engagement and monitoring activities.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

About You

You have significant monitoring experience and a passion for leading, training, and mentoring CRAs. You are adept at developing and maintaining relationships with clinical trial sites and demonstrate the ability to oversee monitoring with a strong knowledge of Good Clinical Practice and clinical trial regulations to ensure subject safety, data integrity and inspection readiness. You have experience developing systems, resources, and tools to support high-quality monitoring and forecast CRA resourcing. You also have experience utilizing a Functional Service Provider (FSP) monitoring model embedded within a sponsor study team to execute major data collection and study milestones. You are a strong collaborator across clinical functional areas with a demonstrated ability to creatively and independently resolve complex issues that impact sites and CRAs.

What You’ll Do 

• Establish and foster effective relationships with internal and external stakeholders, such as the CRO and study team members.
• Promote awareness of Eikon’s clinical pipeline and programs to trial sites, investigators, and networks.
• Complete or oversee the qualification of sites and promptly facilitate site selection to support study milestone goals.
• Develop and maintain strong site relationships to support the site/patient experience and drive study team goals such as enrollment and major study milestones.
• Onboard and train CRAs to conduct high quality site qualification, initiation, and monitoring visits.
• Review and approve monitoring trip reports in the Clinical Trial Management System (CTMS).
• Perform and document monitoring oversight activities to assess monitoring quality and CRA performance.
• At times, perform the CRA role as needed, to support prompt site qualification, initiation, monitoring and close-out visits at key sites to meet urgent study milestones.
• Regularly review site and monitoring Key Risk Indicator (KRI) metrics to detect issues and ensure prompt resolution.
• Serve as an escalation point for CRAs and as a Subject Matter Expert (SME) to resolve site management and monitoring quality issues and develop/ensure implementation of Corrective and Preventive Action (CAPA) Plans as needed.
• Support CRAs to ensure sites are inspection-ready and support Eikon Clinical Quality Assurance during site inspections.
• Effectively utilize the CTMS and Trial Master File (TMF) to ensure SEME documents are promptly filed and site data is accurate.
• Contribute to monitoring process improvement initiatives by developing functional area Standard Operating Procedures (SOPs), Work Instructions (WIs), job aids, and tools.
• Contribute to improving site selection, monitoring, and monitoring oversight trip report templates in Veeva CTMS by identifying gaps, suggesting updates, testing and implementing change controls.

Qualifications

• 8+ years of experience with a Bachelor's degree, or 6+ years with a post graduate degree
• Experience utilizing Veeva CTMS and TMF is required.
• Experience supporting site and/or sponsor inspections is required.
• Working on-site from an Eikon office location (Jersey City, NJ or Millbrae, CA) 3 days per week is required during non-travel weeks.​

The expected hourly range for this role is $77.40 to $84.50 depending on skills, competency, and the market demand for your expertise.

How We Work Together

• Location: This is an on-site position with regional commute requirements, located in Santa Clarita, CA
  • Travel: This role requires up to 10% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives. 
    • Type of travel required: ​Regional (within 100 miles)​ 
  • Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
    
    • Walking - 20%
    • Standing - 20%
    • Sitting - 20%
    • Lifting - 20%
      • Up to 25lbs
      • Over 25lbs Overhead
    • Driving - 20%

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 (for San Francisco Bay Area) or $95,000 to $125,000 (for all other areas) and cash bonus. #LI-IB1

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

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.

Company Profile

Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox™ technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.

Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer.

Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 5 countries: the United States, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com.  

Position Summary

The Manager/Senior Manager of Clinical GCP Quality will be responsible for evaluating and mitigating risk of the global clinical development programs, from initiation through completion of clinical trials, with inspection readiness in mind throughout. The ideal candidate will advise on company clinical quality strategy, ensure compliance to regulations, oversee quality management systems and interact directly with cross functional clinical, regulatory and quality teams. The ideal candidate will have at least 10 years of experience in clinical quality, process improvement, regulatory inspection management and at least two years of clinical auditing experience as lead auditor. The candidate will have an excellent working knowledge of Good Clinical Practices (ICH E6), quality requirements and other international regulations (e.g. US, EU, Taiwan, India, Japan) are desirable.

Key Duties and Responsibilities

• Provide strategic and operational leadership in the planning and executing of GCP Quality activities to support companywide and clinical development/clinical trial Quality activities.

• Successfully lead global and cross-functional quality projects

• Maintains current knowledge of ever-changing clinical quality guidance and regulations.

• Excellent communication and people skills to ensure cohesive and collaborative teamwork. 

• Demonstrated ability to implement and collaboratively drive company initiatives and policies.

• Experience in clinical inspection readiness and acting as the point person for sponsor clinical inspections. Lead Quality hosting clinical site inspection by regulatory agencies highly preferred.

• Direct experience to successfully manage and oversee CAPA plans (write, review, approve, close).

• Successfully demonstrates ability to both conduct and manage sites, internal GCP and vendor audits as well as direct and guide audit follow-up actions. 

• Establish Quality and Cross-Functional SOPs, processes and associated documents. 

• Working closely with clinical pharmacovigilance team on supporting clinical trial safety. 

• Responsible for presenting & updating CGP quality metrics and reporting to Sr. Management. 

• Other duties as assigned. 

Desired Education, Skills and Experience

• B.S. Degree in life sciences with advanced degree in a scientific discipline preferred.
• Minimum of 10 years direct experience in GCP Quality Assurance and/or GCP Compliance.
• Minimum of two years of GCP auditing (e.g. clinical site/clinical vendor) as lead auditor experience preferred.
• Demonstrates strong problem-solving skills, written and verbal communication, and experience in critical QA review of clinical documents.
• Previous experience with oncology, combination drug-device studies, and/or multi-regional with US based clinical trial experience is a plus.
• Pharmacovigilance/Safety QA experience is a plus.
• Medical Device GCP experience is a plus.
• ISO Standard (e.g. ISO13485, ISO9001, ISO27001) understanding is a plus.
• Medical Device Reporting (MDR) – FDA 21 CFR Part 803.
• Pharmacovigilance laws -EU Regulation 520/2012 for drug safety monitoring.
• Experiences with Clinical Quality Management on a risk-based approach is needed.
• Electronic TMF, document, quality, and learning management systems experience
• Strong organizational and project management skills.
• Flexible thinking and team-oriented communication and coordination skills to be able to collaborate in a team environment.
• Professional working proficiency in English

REQUIREMENTS:

Physical Demands

• None, other than those necessary to perform the essential job functions

Manual Dexterity

• None, other than those necessary to perform the essential job functions

Audible/Visual Demands

• Ability to interpret the letters and numbers when viewed on a personal computer screen, PDA, reports and other documents.

Environment

• None, other than those necessary to perform the essential job functions.

Travel

• Up to 30%

The expected salary range for this position based in California is $150,000 to $170,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors.

About the Role

The Medical Science Liaison (MSL) reports to our National Director of Field Medical. MSLs are field-based healthcare professionals to our customers. They will engage in compliant scientific exchange and provide whole practice education on disease state and respond to inquiries related to our products.

Let’s talk about some of the key responsibilities of the role:

• Manage key opinion leader (KOL) optometrists and ophthalmologists in a designated region, ensuring compliant conduct per PhRMA and Tarsus guidelines.
• Be the primary medical affairs KOL point of contact for day-to-day needs and peer-based scientific exchange, adhering to our Tarsus scientific platform; engagements may include both virtual and live interactions.
• Collect actionable insights from field scientific exchange, prioritize and collate these insights to shape medical strategy.
• Provide whole practice education to optometric and ophthalmic centers.
• Provide resources to facilitate disease state education in Optometry schools and Ophthalmology residency programs.
• Instruct customers (upon request) on investigator initiated trial and medical information procedures.
• Compliantly identify and recommend KOLs for a variety of projects (including advisory boards, medical education initiatives, training, publications, special projects, clinical trials, business development evaluations) based on expertise, interests, and competencies.
• Plan KOL engagements and schedule and attend scientific sessions at local, regional and national medical meetings as needed.
• Liaise with local and regional optometric and ophthalmic medical societies
• Present scientific evidence to the payer community.
• Provide leadership and expertise on medical affairs projects and initiatives.
• Participate in continual optimization of training, insights gathering and field medical processes.
• Host local disease state scientific exchanges and “lid+lash labs.”
• Participate in compliant and collaborative engagements with cross-functional team members including training and KOL meetings.
• Provide clinical trial support as needed and determine by the clinical development team.
• Manage territory budget, metrics, KOL mapping and CRM entries.

Factors to Success

• Doctorate of optometry, or MD, PharmD, PhD with eye care expertise required.
• 3+ years of experience as a medical science liaison in eye care is preferred; or 3+ years of clinical experience in eyecare with at least one year of industry experience or 7+ years of clinical practice in eyecare. Senior level exists for those with 4+ years of previous MSL experience.
• Strong emotional intelligence and presentation skills.
• Ability to plan, organize, manage, and prioritize workload proactively in a fast-paced environment.
• Ability to navigate systems and processes including Microsoft Office and customer relationship management software, work independently, and be self-motivated.
• Ability to collect actionable insights and critically analyze data.
• Ability to influence and collaborate with peers.
• Strong verbal and written communication skills to convey technical and clinical information.
• Decision Making - Demonstrates strong decision-making by applying structured analysis to complex challenges, balancing competing priorities and long-term impacts while engaging stakeholders and driving solutions aligned with organizational goals.
• Collaboration and Team Building - Promotes collaboration by aligning diverse teams around shared goals, fostering healthy debate to advance outcomes, and building strong networks that strengthen organizational effectiveness and cross-team learning.
• Outcome Driven - Demonstrates strong outcomes focus by aligning teams around shared priorities, proactively addressing risks and dependencies, and driving cross-functional accountability to sustain progress and deliver results.

A Few Other Details Worth Mentioning:

• The position is field based and requires travel 60-80% of the time.
• Territory includes: Southern California, NV, and HI with candidates ideally located in: Los Angeles, Orange County, San Diego, or Las Vegas
• The candidates must live in their assigned territory, preference will be given to candidates who reside within 45 minutes of a major airport / major metropolitan area.
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
• This position reports directly to our National Director of Field Medical.

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $134,200 to $188,000; with a higher range of $165,000 to $231,000 for candidates hired at the Senior level, plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot.

#LI-Remote

GENERAL SUMMARY: 

This role is in the Biomarkers & Immunology department and supports immunogenicity risk assessments, biomarker measurements, and clinical pharmacology deliverables by developing novel bioanalytical methods and providing expert analysis and interpretation of key bioanalytical datasets. Bioanalytical methods are rigorously qualified and validated to generate high-quality data for internal stakeholders. Working closely with cross-functional teams (e.g., Early-Stage Product Development, Project Management, Clinical Operations, and Clinical Development), these deliverables inform key program decisions.

This position reports to the Director, Biomarkers & Immunology, and supports 4DMT’s mission and portfolio of targeted genetic medicines. On-site work is required for laboratory activities; however, a flexible hybrid schedule may be accommodated for data analysis and remote oversight of partner organizations.

MAJOR DUTIES & RESPONSIBILITIES:

• Provide scientific and technical leadership in the development and qualification of innovative bioanalytical assays, including ligand-binding assays, anti-drug antibody (ADA) assays, cell-based assays, and molecular assays to evaluate immunogenicity, PK/PD, and biomarkers for preclinical and clinical use across multiple therapeutic areas (e.g., ophthalmology, pulmonology, CNS).
• Lead assay lifecycle activities (method development, qualification, validation, and implementation), including defining fit-for-purpose performance criteria, identifying risks, and driving timely resolution of technical issues.
• Oversee GxP workflows and apply relevant regulatory guidance for early-stage and late-stage assay development, validation, and implementation. Ensure data integrity and inspection readiness as applicable.
• Independently design and execute experiments; analyze and interpret data; and communicate conclusions, limitations, and recommendations to management and study teams to enable decisions.
• Contribute to the design and interpretation of in vivo and in vitro studies to support assay development and biomarker strategy, including selection of appropriate readouts and defining decision criteria.
• Assess and select contract research organizations (CROs), lead technology transfer, and manage external assay method development, qualification, and GxP validation, including vendor performance, issue escalation, and corrective actions.
• Partner with Clinical Development and Clinical Operations to define bioanalytical strategy (including sampling strategy and assay performance characteristics) that supports key clinical pharmacology questions (PK/PD, exposure–response, dose selection).
• Review and interpret bioanalytical datasets for quality, trends, and consistency; summarize findings for study teams and contribute to data summaries.
• Author and/or review sections of clinical and regulatory documents (e.g., protocols, sample handling instructions, bioanalytical plans, study reports, Investigator’s Brochure, IND/CTA content) related to PK/PD, immunogenicity, and bioanalytical methods, ensuring scientific accuracy and consistency of key messages.
• Mentor junior staff by providing technical guidance, coaching on experimental design and data interpretation, and reviewing draft deliverables.
• Maintain awareness of relevant scientific literature and emerging technologies; recommend and pilot improvements that increase assay robustness, throughput, or interpretability.
• Write study reports and manuscripts and present results at scientific meetings.
• Maintain compliance with company Environmental Health and Safety policies, procedures, and practices.
• Contribute to a culture of continuous improvement and innovation; encourage team members to expand technical skills and deepen gene therapy expertise.

QUALIFICATIONS:

Education:

• Degree in immunology, bioengineering, molecular biology, cell biology, pharmacology, biochemistry, or a related field.
• PhD with 3+ years of industry or relevant academic experience; Master’s degree with 5+ years; Bachelor’s degree with 7+ years.

Experience:

• Bioanalytical and/or biomarker assay development experience is strongly preferred.
• Experience leading anti-drug antibody assay development and qualification and contributing to validation in a regulated environment (e.g., GxP, as applicable), including defining fit-for-purpose criteria, ensuring data integrity, and troubleshooting complex technical issues. Experience with PCR, qPCR, and droplet digital PCR; RNA-seq; and tissue culture of primary cells and established cell lines. Familiarity with ligand binding assays and LC-MS is a plus.
• Late-stage clinical trial experience, biologics license application experience, and CRO oversight (including deliverable review, issue escalation, and corrective actions) are a plus.
• Working knowledge of clinical pharmacology concepts (PK/PD, exposure metrics, dose selection, exposure–response) and experience translating study objectives into bioanalytical strategy (e.g., sampling strategy, assay performance characteristics), data generation plans, and interpretation for biologics and/or gene therapies is preferred.

Other Qualifications/Skills:

• Competence in standard microplate reader use (e.g., SoftMax software), Meso Scale Discovery platform instruments, PCR primer/probe design, and protein labeling, detection, and purification techniques.
• Demonstrated ability to independently design, develop, and execute new assay methods and to provide technical leadership through critical review of experimental plans, data quality, and conclusions.
• Strong attention to detail with the ability to rigorously analyze and interpret data, ensure data integrity and inspection-ready documentation as applicable.
• Demonstrated ability to influence cross-functional decisions by identifying bioanalytical risks, proposing mitigation plans, and aligning stakeholders on fit-for-purpose approaches.
• Ability to work cooperatively in a team-based environment, supportive of multiple viewpoints and approaches, and able to provide constructive scientific feedback.
• Strong written and verbal communication skills, with demonstrated ability to frame complex data into clear recommendations for diverse audiences (e.g., study teams, functional leaders, and external partners).
• Ability to translate assay performance (e.g., sensitivity, selectivity, drug tolerance, stability, dilutional linearity) into fit-for-purpose guidance for clinical and nonclinical analyses.
• Familiarity with data workflows and common analysis/reporting tools used to summarize and trend bioanalytical results (e.g., Excel, JMP, GraphPad Prism; Python and/or R is a plus).

Travel: <5%

Physical Requirements and Working Conditions:

• Ability to lift up to 20 lbs; bend and twist; and wear personal protective equipment (PPE) such as a lab coat, goggles/glasses, and nitrile gloves.

Base salary compensation range:$164,000 -182,000

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.

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