Executive Director, Clinical Development (Autoimmune)
Job Type: Full Time
Salary: 200K - 300K
Location: Alameda, CA (3-4 days a week onsite)
Company Summary:
Our client is a global clinical-stage biotechnology company pioneering cell therapies to treat cancer and autoimmune diseases. Founded in 2017, they leverage ACC technology to arm T cells with tumor targeting antibodies. Their platform incorporates click chemistry, a Nobel Prize-winning technology known to increase precision and efficiency.
About the role:
As the Executive Director, Clinical Development in a small, agile team, you will work directly with the CEO and executive leadership to drive early development strategy and execution for our lead allogeneic gamma delta T cell therapy. You'll have the chance to build and lead a nimble team while playing an active, hands-on role in protocol development, trial execution, data analysis, and regulatory planning.
Key Responsibilities:
- Strategic Leadership
- Define and lead overall clinical development strategy
- Prioritize indications based on scientific rationale, unmet medical need, and regulatory and commercial feasibility
- Serve as a core member of the executive team, including portfolio and program level decision-making
- Clinical Development
- Design and oversee Ph 1/2 pivotal trials
- Lead protocol development, data review, and interpretation to inform clinical decision making
- Collaborate with investigators and KOLs to expand clinical applications and evidence generation
- Regulatory & Medical Strategy
- Lead regulatory interactions and engage with global health authorities to support clinical programs
- Team Building & Cross- Functional Coordination
- Build and lead a high performing clinical development team
- Key individual contributor during early stages while scaling the function
- Represent the autoimmune development strategy internally and externally
Requirements:
- MD, MD/PhD, or PharmD
- 10+ years of clinical development experience - MUST HAVE PHASE I/II
- 3+ years of experience at Senior Director level or currently, an Executive Director
- Proven success in building and leading clinical function at a small biotech
- Background in cell therapy, monoclobal antibodies, or B cell targeted agents is preferred.
- Mandarin proficiency is a plus.
- Willingness to travel internationally.
Benefits:
- Pre-IPO (US) equity
- Competitive benefits package and 401K matching
- Opportunity to build and lead a clinical group from group up at an organization with promising science and an innovative team.
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