EPM Scientific
Senior Director, Clinical Operations - Immunology & Inflammation (I&I)
EPM Scientific, San Francisco, California, United States, 94199
Senior Director, Clinical Operations - Immunology & Inflammation (I&I)
Find out exactly what skills, experience, and qualifications you will need to succeed in this role before applying below. Location:
Remote (U.S.); San Francisco-based candidates strongly preferred
Overview The Senior Director, Clinical Operations, will lead global operational strategy and delivery across the I&I portfolio. Reporting to the VP/Head of Clinical Operations, this leader will own end‑to‑end study execution (Phase 1-3), build and manage a high‑performing team, and ensure programs meet timeline, quality, budget, and compliance goals.
Key Responsibilities
Strategic Leadership: Define and implement clinical operations strategies for multiple I&I programs.
Trial Execution: Oversee all aspects of clinical trial delivery, including protocol development, site selection, enrollment, monitoring, and close-out.
Vendor Oversight: Manage CROs and other external partners to ensure quality, compliance, and timely execution.
Budget & Resource Management: Develop and manage clinical budgets and resource plans.
Compliance & Quality: Ensure adherence to ICH/GCP, regulatory requirements, and internal SOPs.
Cross-Functional Collaboration: Partner with Clinical Development, Regulatory, Biometrics, and Medical Affairs to achieve program objectives.
Team Development: Recruit, mentor, and lead a high-performing Clinical Operations team.
Qualifications
Experience: 15+ years in Clinical Operations with 8+ years leading global trials; track record delivering Phase 1-3 studies in biotech or pharma.
Therapeutic Expertise: Demonstrated experience in I&I (e.g., dermatology, rheumatology, respiratory, or GI).
Operational Excellence: Proven success with CRO oversight, complex protocol execution, multi‑country activation, enrollment leadership, and inspection readiness.
Leadership: Ability to build, scale, and motivate high‑performing teams; strong communication and stakeholder management; thrives in a fast‑paced, growth‑stage environment.
Technical Knowledge: Solid understanding of ICH/GCP, global regulatory expectations, risk‑based monitoring, and data integrity principles.
Education: Bachelor's degree in Life Sciences required; advanced degree preferred.
What the Company Offers
Opportunity to shape and scale Clinical Operations in a well‑funded, clinical‑stage environment with near‑term clinical catalysts.
Collaborative culture that values clarity, accountability, and patient impact.
Competitive compensation including base salary, annual bonus, long‑term equity, and comprehensive benefits.
Hybrid work model with flexibility for the right senior‑level candidate.
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Find out exactly what skills, experience, and qualifications you will need to succeed in this role before applying below. Location:
Remote (U.S.); San Francisco-based candidates strongly preferred
Overview The Senior Director, Clinical Operations, will lead global operational strategy and delivery across the I&I portfolio. Reporting to the VP/Head of Clinical Operations, this leader will own end‑to‑end study execution (Phase 1-3), build and manage a high‑performing team, and ensure programs meet timeline, quality, budget, and compliance goals.
Key Responsibilities
Strategic Leadership: Define and implement clinical operations strategies for multiple I&I programs.
Trial Execution: Oversee all aspects of clinical trial delivery, including protocol development, site selection, enrollment, monitoring, and close-out.
Vendor Oversight: Manage CROs and other external partners to ensure quality, compliance, and timely execution.
Budget & Resource Management: Develop and manage clinical budgets and resource plans.
Compliance & Quality: Ensure adherence to ICH/GCP, regulatory requirements, and internal SOPs.
Cross-Functional Collaboration: Partner with Clinical Development, Regulatory, Biometrics, and Medical Affairs to achieve program objectives.
Team Development: Recruit, mentor, and lead a high-performing Clinical Operations team.
Qualifications
Experience: 15+ years in Clinical Operations with 8+ years leading global trials; track record delivering Phase 1-3 studies in biotech or pharma.
Therapeutic Expertise: Demonstrated experience in I&I (e.g., dermatology, rheumatology, respiratory, or GI).
Operational Excellence: Proven success with CRO oversight, complex protocol execution, multi‑country activation, enrollment leadership, and inspection readiness.
Leadership: Ability to build, scale, and motivate high‑performing teams; strong communication and stakeholder management; thrives in a fast‑paced, growth‑stage environment.
Technical Knowledge: Solid understanding of ICH/GCP, global regulatory expectations, risk‑based monitoring, and data integrity principles.
Education: Bachelor's degree in Life Sciences required; advanced degree preferred.
What the Company Offers
Opportunity to shape and scale Clinical Operations in a well‑funded, clinical‑stage environment with near‑term clinical catalysts.
Collaborative culture that values clarity, accountability, and patient impact.
Competitive compensation including base salary, annual bonus, long‑term equity, and comprehensive benefits.
Hybrid work model with flexibility for the right senior‑level candidate.
#J-18808-Ljbffr