VP, Clinical Development / CMO / CDO
About Us
We are an early-stage biotech company developing drugs with the goal of reducing multi-morbidity and earning an indication for aging, as opposed to the treatment of specific diseases. Our ultimate mission is to establish aging as a therapeutic area and empower humans with more time with loved ones and autonomy over their health. This is a new paradigm focused on keeping healthy people healthy as opposed to treating individual diseases after they occur.
Read more in our Candidate Guide.
Key Responsibilities
Design & Own the Clinical Roadmap: Develop and own the integrated clinical plan for our lead program and broader pipeline.
Regulatory Coordination: Work closely with our regulatory lead to strategize and execute a regulatory strategy for aging therapies. Lead all major regulatory interactions - briefing packages, meeting prep, post-meeting strategies.
Program Management: Track milestones and dependencies to keep trials on schedule and under budget.
Develop and Validate Novel Aging Endpoints: Collaborate with scientific and regulatory stakeholders to define, validate, and advocate for new clinical endpoints that capture aging-related healthspan improvements.
Innovate in Trial Design: Incorporate decentralized trials, adaptive protocols, AI-driven endpoints, and real-world data to cut costs, accelerate timelines, and maximize impact.
Build the Team: Hire, mentor, and inspire a world-class clinical and regulatory team, with no ego and a high bar for performance, creativity, and mission alignment.
Drive Quality and Compliance: Develop and institutionalize a biotech-focused QMS.
Success Measures
Within the First 3–6 Months, You Will Have:
Delivered a Briefing Package for our second FDA Type C Meeting, integrating inputs from clinical ops, regulatory, CMC, and external experts.
Finalized Phase 1 Study Synopses (focusing on fixed-dose combination PK/safety), incorporating FDA feedback and bridging strategies for a 505(b)(2) or similar pathway.
Mapped a Multi-Country Clinical Development Plan that accounts for differing regulatory views on aging endpoints, accelerating potential global acceptance.
Built Core Clinical Team & Processes: Hired 2–3 specialized staff (trial ops, regulatory managers), instituted a biotech-specific QMS, and established training protocols.
Established Integration with AI/Data Leads to ensure Phase 1 readouts can be tracked in real-time, especially for unique combination PK/PD data.
Within the First Year, You Will Have:
Navigated Key FDA Milestones such that the IND for AUTO-1 is approved on schedule; shaped a feasible Phase 3 design aligned with FDA insights on aging endpoints.
Executed a Timely Phase 1 Readout that validates combination safety data, enabling immediate pivot or progression to Phase 3.
Formed External Alliances & Collaborations with academic sites and KOLs in geriatric cardiology/metabolism, possibly advancing major pharma partnership opportunities.
Expanded the Clinical Organization to manage parallel pipeline programs, hiring additional senior managers in clinical development, trial ops, and regulatory.
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Implemented Continuous Innovation in Trial Design (digital endpoints, remote data capture, adaptive protocols) to reduce cost per patient and overall trial duration.
Required Skills & Competencies
Strong Ownership & Leadership: Proven ability to “run the show” for clinical development, orchestrating cross-functional teams with autonomy and accountability.
Hiring & Talent Magnet: Deep network in clinical development; adept at building and scaling teams from scratch, especially in early-stage biotech.
Creative Problem-Solving & Cost Reduction: Track record of innovating clinical trial designs (e.g., decentralized, AI-driven) to reduce timeline and budget by 20–30%.
Regulatory & Geriatric Endpoint Expertise: Skilled at navigating FDA processes for combination products and demonstrating synergy; familiarity with unique geriatric endpoints such as intrinsic capacity or multi-factor biomarkers.
Rigor & Detail Orientation: Highly meticulous with briefing materials, risk assessments, and scenario planning; understands how to proactively manage FDA queries.
Resilience & Toughness: Comfortable in fast-paced, high-stakes environments. Willing to stand firm under pressure from executives, investors, and regulators alike.
Preferred Qualifications
3+ Years of Senior Clinical Development Experience in biotech, pharma, or a related field, ideally with at least 2 years in a startup environment.
Experience with Long-Duration Studies: Experience handling 5–7-year follow-up trials or outcomes-based studies with novel endpoints.
Global Regulatory Acumen: Experience aligning clinical endpoints across multiple regulatory bodies and geographies.
Advanced Degree (MD or Equivalent) in a related Life Sciences field preferred.
Experience in Therapeutic Areas Without Established Endpoints: Comfortable designing and validating new clinical endpoints where regulatory precedents are limited or evolving.
Experience in the therapeutic areas: neurodegeneration, cardiometabolism, rare diseases or vaccines.
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