Medical Director/Senior Medical Director, Clinical Development

• Lead clinical program strategy
  • Define and refine clinical development plans from FIH through proof‑of‑concept and into pivotal planning
  • Contribute to target product profiles, indication sequencing, and lifecycle strategy across cardiometabolic and related franchises
  • Integrate nonclinical, translational, and clinical data to inform dose selection, patient population, and endpoint strategy
• Own medical leadership for key studies
  • Serve as global medical lead for assigned studies/programs, providing medical and scientific leadership to cross‑functional teams
  • Lead the design of Phase 1–2 trials (and contribute to Phase 3 planning), including objectives, endpoints, inclusion/exclusion criteria, and risk–benefit considerations
  • Chair or co‑chair safety review / dose‑escalation committees, ensuring timely, balanced dose decisions grounded in safety and PK/PD data
• Ensure high‑quality clinical and regulatory documentation
  • Lead or oversee authoring of clinical components of protocols, IBs, ICFs, CSRs, pediatric plans, and other key documents
  • Author clinical sections of regulatory submissions (e.g., IND/CTA, briefing packages, responses to health authorities) and participate in FDA/EMA and other agency interactions
  • Partner with Biostatistics, Clinical Pharmacology, and Translational Science on endpoint hierarchy, statistical analysis plans, and biomarker strategies
• Provide ongoing medical oversight and safety leadership
  • Provide medical monitoring oversight, including review of eligibility, safety signals, and protocol deviations
  • Collaborate with Pharmacovigilance on safety evaluation, signal detection, and risk mitigation strategies
  • Lead or contribute to Safety Review Committees/Data Monitoring Committees, including review of safety narratives and serious adverse events
• Drive data interpretation and communication
  • Lead integrated interpretation of efficacy, safety, PK/PD, and biomarker data for internal decision‑making and external communication
  • Prepare and deliver presentations to internal governance, board‑level committees as appropriate, and external stakeholders
  • Oversee or contribute to abstracts, posters, and manuscripts for major scientific and medical congresses and peer‑reviewed journals
• Engage with investigators, KOLs, and external partners
  • Build and maintain strong relationships with investigators and KOLs in cardiometabolic medicine and related fields
  • Lead or co‑lead advisory boards and scientific consultations, ensuring external insights are incorporated into program strategy and study design
  • Collaborate with CROs and other vendors to ensure alignment on medical/scientific expectations and quality
• Mentor and build the clinical organization
  • Provide coaching and guidance to Clinical Scientists, Medical Monitors, and Clinical Operations colleagues
  • Help shape clinical development best practices, templates, and processes across the portfolio
  • Model a culture of scientific rigor, transparency, and cross‑functional collaboration

• Education and clinical training
  • o MD or equivalent medical degree required
  • o Board certification in Internal Medicine with subspecialty training in Endocrinology, Cardiology, or related cardiometabolic field strongly preferred
  • o Active or eligible medical licensure in at least one jurisdiction
• Industry and clinical development experience
  • o Typically 7–10+ years of experience in biotech/pharma clinical development, with increasing responsibility; prior experience as global or study medical lead strongly preferred
  • o Demonstrated leadership of early clinical development (FIH, SAD/MAD, PoC) and contribution to later‑phase plans in cardiometabolic or closely related indications (e.g., obesity, diabetes, dyslipidemia, NAFLD/NASH, cardiovascular risk)
  • o Proven track record of health authority interactions (e.g., FDA Type B/C meetings, EMA Scientific Advice) and contribution to major submissions
• Technical and scientific skills
  • o Deep understanding of cardiometabolic pathophysiology, standard‑of‑care therapies, and evolving therapeutic landscape
  • o Strong grasp of clinical trial design, statistics, PK/PD, and biomarker integration, with ability to challenge and refine analytical plans
  • o Experience with cardiometabolic endpoints and tools (e.g., HbA1c, weight and body composition, lipids, blood pressure, imaging, functional assessments, composite risk scores)
  • o Excellent scientific and medical writing skills; able to produce clear, high‑quality documents under tight timelines
• Leadership and core competencies
  • o Demonstrated ability to lead cross‑functional teams, influence without authority, and drive decisions in the face of ambiguity
  • o Highly organized and execution‑oriented, able to manage multiple programs and priorities in a fast‑moving environment
  • o Strong communicator, able to translate complex clinical and scientific concepts for diverse audiences including executives, regulators, investigators, and non‑clinical functions
  • o Entrepreneurial, solutions‑oriented mindset with a willingness to be “hands‑on” in a growing organization
  • o Unwavering commitment to patient safety, ethical conduct, data integrity, and quality

Expected salary range:

• $270,000-360,000 annual base salary

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