Clinical Development Scientist/Senior Clinical Development Scientist
About The Position
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 a scientifically rigorous and highly collaborative Clinical Scientist to support the design and execution of early clinical development programs across multiple indications including cardiometabolic and neuroinflammatory diseases. This role is ideal for candidates who have deep hands-on study execution experience coupled with critical scientific and strategic thinking. The Clinical Scientist will work closely with Clinical Operations, Clinical Pharmacology, Biometrics, Translational Science, and Regulatory to ensure high‑quality clinical plans, protocols, and data readouts. This role can be remote, hybrid, or on-site, and reports within the Clinical Development group.
Requirements
- PharmD or PhD in life sciences, pharmacology, physiology, or related field strongly preferred; MD or equivalent clinical degree also considered
- Strong foundation in cardiometabolic biology (e.g., obesity, insulin resistance, dyslipidemia, NAFLD/NASH, cardiovascular risk) or neuroinflammation (e.g. neurodegeneration, neuropathic pain) is highly preferred
- Typically 3–7+ years of relevant experience in clinical development, clinical pharmacology, or translational medicine within biotech/pharma or equivalent academic clinical research environment
- Demonstrated experience contributing to design and execution of early‑phase (Phase 1–2) clinical trials
- Cardiometabolic and/or obesity and/or neurologic clinical trial experience preferred,
- Experience working on cross‑functional teams with Clinical Operations, Biometrics, Regulatory, and Translational/Discovery
- Prior involvement in regulatory submissions (e.g., IND/CTA, briefing packages, responses to queries) is a plus
- Strong understanding of clinical trial methodology, GCP, and the overall drug development pathway from FIH through proof‑of‑concept
- Comfort interpreting PK/PD, biomarker, and clinical efficacy/safety data, and working with statisticians and pharmacometricians
- Excellent scientific writing skills with a track record of clear, structured documents and presentations
- Highly organized, with the ability to manage multiple studies or workstreams in parallel in a fast‑paced environment
- Strong analytical and critical‑thinking skills; able to move from complex data to clear, actionable recommendations
- Effective communicator, able to tailor scientific messages to diverse audiences (clinicians, scientists, operations, leadership, regulators)
- Demonstrated ability to work collaboratively and constructively across disciplines and with external partners
- Commitment to high ethical standards, patient safety, and data integrity
Responsibilities
- Lead development of core clinical documents
- Author or co‑author clinical sections of protocols, protocol amendments, IB updates, ICFs, clinical and scientific training material, medical monitoring plans, safety/review/ dose escalation committee charters.
- Translate protocol intent into operational deliverables such as CRFs and eCRF completion guidelines, lab and pharmacy manuals. Develop or contribute to study‑level documents, including medical monitoring plans, safety review / dose escalation committee charters, data review plans, and statistical analysis plans
- Draft and review clinical sections of regulatory documents and responses, including Health Authority interactions, briefing books, IND and annual reports, and safety updates
- Drive study conduct and data quality
- Serve as Clinical Scientist lead on cross‑functional study teams for selected trials
- Provide clinical and scientific input into site selection, eligibility reviews, and key study tools (e.g., manuals, training decks, CRFs)
- Perform routine reviews of patient profiles, listings, coded terms, and narratives. Monitor for trends across safety, efficacy, and protocol compliance; help define and track key data review listings and visualizations
- Contribute to the interpretation of emerging clinical safety and efficacy data.
- Support development and execution of safety review / dose escalation committees and data monitoring activities
- Lead data interpretation and communication
- Lead or co-lead integrated analyses of clinical safety/efficacy, PK/PD, and biomarker data to generate clear conclusions and next‑step recommendations
- Prepare data summaries and presentations for internal governance, external collaborators, and advisory boards
- Lead clinical study report authoring
- Contribute to abstracts, posters, and manuscripts for scientific meetings and peer‑reviewed journals
- Interface with investigators and external partners
- Provide scientific support to investigators and study sites (e.g., training, protocol clarification, scientific Q&A)
- Participate in KOL and expert advisory boards, contributing to agenda, content, and follow‑up
- Collaborate with CROs, central labs, imaging/biomarker vendors, and other partners to ensure alignment on scientific and operational expectations
- Contribute to clinical strategy and study design
- Support development of clinical development plans, target product profiles, and indication prioritization
- Lead or co‑lead the scientific design of Phase 1–2 studies (e.g., FIH, dose‑finding, PoC) including objectives, endpoints, inclusion/exclusion criteria, and biomarker strategy,
- Integrate nonclinical, translational, and clinical data to inform dose selection, schedule, and patient population
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
