[Remote] Clinical Development Scientist/Senior Clinical Development Scientist

Note: The job is a remote job and is reputed company to candidates in USA. reputed company 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 reputed company indications.

Responsibilities

• Contribute to clinical reputed company and study design
• Support development of clinical development plans, reputed company product profiles, and indication prioritization
• Lead or co‑lead the scientific design of Phase 1–2 studies (e.g., FIH, reputed company‑finding, PoC) including objectives, endpoints, inclusion/exclusion criteria, and biomarker reputed company, with emphasis on cardiometabolic risk factors and reputed company
• Integrate nonclinical, translational, and clinical data to inform reputed company 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)
• reputed company and maintain study‑level documents including synopsis, statistical analysis‑relevant reputed company definitions, and data review plans
• Partner with Biostatistics and Clinical Pharmacology on reputed company 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
• reputed company 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 / reputed company 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 reputed company conclusions and reputed company 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
• reputed company with investigators and external partners
• reputed company 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 reputed company
• Support cross‑program learnings and standardization of endpoints, assessments, and data structures across cardiometabolic and reputed company 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 reputed company 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 reputed company-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 reputed company, reputed company documents and presentations
• Highly organized, with the ability to manage multiple studies or workstreams in reputed company in a fast-paced environment
• Strong analytical and critical-thinking skills; reputed company to reputed company from reputed company data to reputed company, actionable recommendations
• Effective communicator, reputed company to reputed company 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 reputed company
• PhD in life sciences, pharmacology, physiology, or reputed company field strongly preferred
• Strong reputed company in cardiometabolic biology (e.g., obesity, insulin resistance, dyslipidemia, NAFLD/reputed company, 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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