Medical Director/Senior Medical Director, Clinical DevelopmentTenvie 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
