Medical Director/Senior Medical Director, Clinical Development

Medical Director/Senior Medical Director, Clinical Development

Tenvie Therapeutics is developing precision‑engineered small molecule therapies to address core drivers of neurological and peripheral diseases: neuroinflammation and cellular dysfunction. Leveraging its proprietary product engine, Tenvie has the unique ability to advance both fully CNS‑penetrant and peripherally restricted products across a broad portfolio. Tenvie’s most advanced programs, TNV262 and TNV108, are in Phase 1 clinical development. TNV262 is a fully CNS-penetrant NLRP3 inhibitor targeting cardiometabolic and neuroinflammatory indications, including obesity and cardiovascular disease, and multiple sclerosis. TNV108 is a peripherally restricted SARM1 allosteric inhibitor targeting peripheral neuropathies. Tenvie’s clinical pipeline is complemented by discovery-stage programs across a range of related indications.
Tenvie Therapeutics is seeking an experienced, hands-on Medical Director to lead early- and mid-stage clinical programs in cardiometabolic disease and related indications. This physician leader will drive clinical strategy, study design, and medical oversight, partnering closely with cross-functional colleagues to advance differentiated therapies for patients with high unmet medical need. This role can be remote, hybrid, or on-site, and reports within the Clinical Development group.

JOB RESPONSIBILITIES:

• 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

QUALIFICATIONS:

• 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

Tenvie is proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability or any other status protected under federal, state or local law. All employment is decided on the basis of qualifications, merit and business need.