Tenvie Therapeutics · 1 week ago
Clinical Development Scientist/Senior Clinical Development Scientist
United States
Full-time
Remote
Mid, Senior Level
$125K/yr - $180K/yr
3+ years expTenvie 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.
BiotechnologyHealthcareLife ScienceMedicalNeuroscienceTherapeutics
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
Qualification
Required
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
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
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
Preferred
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)
Company
Tenvie Therapeutics
Tenvie Therapeutics is a biotechnology company that transforms the treatment of neurological diseases through engineered small molecules.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$200MKey Investors
ARCH Venture Partners,F-Prime,Mubadala Capital
2025-01-08Series A· $200M
Leadership Team
Tony Estrada
Co-Founder, President & CEO
Javier Vicente
VP, Research Operations
Recent News
2026-05-06
Clinical Trials Arena
2026-04-22
Company data provided by crunchbase