Note: The job is a remote job and is open to candidates in USA. Tenvie Therapeutics is developing precision‑engineered small molecule therapies to address core drivers of neurological and peripheral diseases. They are seeking a Clinical Scientist to support the design and execution of early clinical development programs in cardiometabolic disease and related indications.
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
Skills
- 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
- 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
- Comfortable operating with ambiguity and evolving data; proactive in identifying risks and proposing solutions
- Commitment to high ethical standards, patient safety, and data integrity
- PhD in life sciences, pharmacology, physiology, or related field strongly preferred
- Strong foundation in cardiometabolic biology (e.g., obesity, insulin resistance, dyslipidemia, NAFLD/NASH, cardiovascular risk) is highly preferred
- 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)
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