Clinical Development Scientist/Senior Clinical Development Scientist at Tenvie Therapeutics

Brisbane, California, United States -

Full Time

Start Date

Immediate

Expiry Date

29 Aug, 26

Salary

180000.0

Posted On

31 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trial Design, Cardiometabolic Biology, Phase 1-2 Study Execution, Scientific Writing, PK/PD Modeling, GCP, Regulatory Submissions, Biomarker Strategy, Data Interpretation, Cross-functional Collaboration, Protocol Development, Clinical Pharmacology, Translational Medicine, Patient Population Selection, Medical Data Review, KOL Engagement

Industry

Description

Clinical Development Scientist/Senior Clinical Development Scientist 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 in cardiometabolic disease and related indications. This role is ideal for candidates with a strong background in human pathophysiology and clinical trial design who are motivated to translate biology into impactful therapies. The Clinical Scientist will work closely with Clinical Development, Clinical Operations, 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. JOB RESPONSIBILITIES: 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, with emphasis on cardiometabolic risk factors and outcomes Integrate nonclinical, translational, and clinical data to inform dose selection, schedule, and patient population Lead development of core clinical documents Author or co‑author clinical sections of protocols, protocol amendments, IBs, ICFs, CSRs, and relevant regulatory documents (e.g., briefing books, responses to health authority questions) Develop and maintain study‑level documents including synopsis, statistical analysis‑relevant endpoint definitions, and data review plans Partner with Biostatistics and Clinical Pharmacology on endpoint hierarchy, PK/PD modeling plans, and interim analyses 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 adjudication, and key study tools (e.g., manuals, training decks, CRFs) Participate in ongoing medical and scientific data review (safety, PK/PD, biomarkers, efficacy signals); help define and track key data review listings and visualizations 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, 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 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 portfolio and organizational excellence Support cross‑program learnings and standardization of endpoints, assessments, and data structures across cardiometabolic and related indications Help refine internal processes and templates for protocols, charters, and data review Mentor junior team members as appropriate; model a high‑accountability, low‑ego, cross‑functional working style QUALIFICATIONS: Education PhD in life sciences, pharmacology, physiology, or related field strongly preferred; MD, PharmD, or equivalent clinical degree also considered Strong foundation in cardiometabolic biology (e.g., obesity, insulin resistance, dyslipidemia, NAFLD/NASH, cardiovascular risk) is highly preferred Experience 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 clinical trial experience preferred, including familiarity with standard endpoints (e.g., glycemic control, body weight, lipids, blood pressure, imaging or functional assessments) 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 Technical skills 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 Experience with cardiometabolic risk scoring, metabolic biomarker panels, or imaging modalities is an advantage Excellent scientific writing skills with a track record of clear, structured documents and presentations Core competencies 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 Comfortable operating with ambiguity and evolving data; proactive in identifying risks and proposing solutions Commitment to high ethical standards, patient safety, and data integrity Expected salary range: $125,000-180,000 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.

Responsibilities

The role involves leading the scientific design and execution of early-phase clinical trials for cardiometabolic diseases, including authoring core clinical documents. The scientist will integrate translational data to inform dosing and collaborate cross-functionally to ensure high-quality data readouts.