Clinical Development Scientist/Senior Clinical Development Scientist

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

Pay

Expected salary range: $125,000-180,000 annual base salary