VP, Clinical Development / CMO / CDO

Job description

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 https://strong-transport-ceb.notion.site/Candidate-Guide-1a01fc245011803fbc7becb61ea1d52c?pvs=4. 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: 1. Delivered a Briefing Package for our second FDA Type C Meeting, integrating inputs from clinical ops, regulatory, CMC, and external experts. 2. 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. 3. Mapped a Multi-Country Clinical Development Plan that accounts for differing regulatory views on aging endpoints, accelerating potential global acceptance. 4. Built Core Clinical Team & Processes: Hired 2–3 specialized staff (trial ops, regulatory managers), instituted a biotech-specific QMS, and established training protocols. 5. 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: 1. 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. 2. Executed a Timely Phase 1 Readout that validates combination safety data, enabling immediate pivot or progression to Phase 3. 3. Formed External Alliances & Collaborations with academic sites and KOLs in geriatric cardiology/metabolism, possibly advancing major pharma partnership opportunities. 4. Expanded the Clinical Organization to manage parallel pipeline programs, hiring additional senior managers in clinical development, trial ops, and regulatory. 5. 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 1. Strong Ownership & Leadership: Proven ability to “run the show” for clinical development, orchestrating cross-functional teams with autonomy and accountability. 2. Hiring & Talent Magnet: Deep network in clinical development; adept at building and scaling teams from scratch, especially in early-stage biotech. 3. 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%. 4. 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. 5. Rigor & Detail Orientation: Highly meticulous with briefing materials, risk assessments, and scenario planning; understands how to proactively manage FDA queries. 6. 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.