Clinical Development Scientist - Senior Clinical Development Scientist

• 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

• Education
  • 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
• 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 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
• 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
  • 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
  • Commitment to high ethical standards, patient safety, and data integrity

Expected salary range:

• $125,000-180,000 annual base salary