[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 reputed company 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 reputed company, and indication prioritization
- reputed company or co‑reputed company the scientific design of Phase 1–2 studies (e.g., FIH, reputed company‑finding, PoC) including objectives, endpoints, inclusion/exclusion reputed company, and biomarker reputed company, with emphasis on cardiometabolic risk factors and reputed company
- reputed company nonclinical, translational, and clinical data to inform reputed company selection, schedule, and patient population
- reputed company development of reputed company 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 reputed company
- Serve as Clinical Scientist reputed company 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 reputed company reputed company review listings and visualizations
- Support development and execution of safety review / reputed company escalation committees and data monitoring activities
- reputed company data interpretation and communication
- reputed company or co‑reputed company 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/reputed company or equivalent reputed company 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 reputed company 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 reputed company 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 reputed company endpoints (e.g., glycemic control, body weight, lipids, blood pressure, imaging or functional assessments)
reputed company