About this opportunity
Tenvie Therapeutics, Inc. lists this Medical Director/Senior Medical Director, Clinical Development opportunity in california, Missouri. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Medical Director/Senior Medical Director, Clinical Development
TenvieTherapeuticsis developing precision‑engineered small molecule therapies to address core drivers of neurological and peripheral diseases: neuroinflammation and cellular dysfunction. Leveraging its proprietary product engine,Tenviehas the unique ability to advance both fully CNS‑penetrant and peripherally restricted products across a broad portfolio.Tenvie’smost advanced programs, TNV262 and TNV108,are in Phase 1 clinical development.TNV262isa fully CNS-penetrant NLRP3 inhibitor targeting cardiometabolicand neuroinflammatoryindications, including obesityandcardiovascular disease,andmultiple sclerosis.TNV108isa peripherally restricted SARM1 allosteric inhibitor targeting peripheral neuropathies.Tenvie’sclinical pipeline is complemented by discovery-stage programs across a range of related indications.
Tenvie Therapeutics is seeking a Medical Director to lead early- and mid-stage clinical programs across multiple indications including cardiometabolic and neurologic diseases. This physician leader will drive successful clinical trial execution, provide medical oversight, and support regulatory submissions 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:
Provide medical leadership for key studies Serve asglobal medical leadfor 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‑chairsafety 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 ofprotocols, IBs, ICFs, CSRs, pediatric plans, and other key documents
Author clinical sections ofregulatory 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 Oversee medical monitoring, including eligibility reviews, safety signal monitoring, and protocol deviations
Collaborate with Pharmacovigilance on safety evaluation, signal detection, and risk mitigation strategies
Lead or contribute toSafety Review Committees/Data Monitoring Committees, including review of safety narratives and serious adverse events
Drive data interpretation and communication Lead integrated interpretation ofefficacy, safety, PK/PD, and biomarker datafor internal decision‑making and external communication
Prepare and deliver presentations to internal governance, board‑level committees as appropriate, and external stakeholders
Oversee or contribute toabstracts, posters, and manuscriptsfor major scientific and medical congresses and peer‑reviewed journals
Engage with investigators, KOLs, and external partners Build and maintain strong relationships withinvestigators and KOLs
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
Contribute to portfolio and organizational excellence 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 inInternal Medicinewith subspecialty training inEndocrinology, Cardiology, or Neurology field strongly preferred
o Active or eligible medical licensure in at least one jurisdiction
Industry and clinical development experience o Typically7–10+ yearsof experience in biotech/pharma clinical development, with increasing responsibility; prior experience asglobal or study medical leadstrongly preferred
o Proven track record in health authority interactions(e.g., FDA Type B/C meetings, EMA Scientific Advice), contribution to major submissions, and cross functional collaboration
Technical and scientific skills o Strong grasp ofclinical trial design, statistics, PK/PD, and biomarker integration, with ability to challenge and refine analytical plans
o Excellentscientific and medical writingskills; able to produce clear, high‑quality documents under tight timelines
Leadership and core competencies o Demonstrated ability tolead cross‑functional teams
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 Unwavering commitment topatient 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.
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Worksite address
california, MO, 65018, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.