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, 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
MD or equivalent medical degree required
Board certification in
Internal Medicine
with subspecialty training in
Endocrinology, Cardiology, or related cardiometabolic field
strongly preferred
Active or eligible medical licensure in at least one jurisdiction
Industry and clinical development experience
Typically
7–10+ years
of experience in biotech/pharma clinical development, with increasing responsibility; prior experience as
global or study medical lead
strongly preferred
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)
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
Deep understanding of
cardiometabolic pathophysiology, standard‑of‑care therapies, and evolving therapeutic landscape
Strong grasp of
clinical trial design, statistics, PK/PD, and biomarker integration, with ability to challenge and refine analytical plans
Experience with cardiometabolic endpoints and tools (e.g., HbA1c, weight and body composition, lipids, blood pressure, imaging, functional assessments, composite risk scores)
Excellent
scientific and medical writing
skills; able to produce clear, high‑quality documents under tight timelines
Leadership and core competencies
Demonstrated ability to
lead cross‑functional teams, influence without authority, and drive decisions in the face of ambiguity
Highly organized and execution‑oriented, able to manage multiple programs and priorities in a fast‑moving environment
Strong communicator, able to translate complex clinical and scientific concepts for diverse audiences including executives, regulators, investigators, and non‑clinical functions
Entrepreneurial, solutions‑oriented mindset with a willingness to be “hands‑on” in a growing organization
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.
#J-18808-Ljbffr