What You'll DoThe Clinical Scientist will provide clinical and scientific expertise to deliver clinical studies in early- and/or late-stage development. This individual will be responsible for the hands-on implementation and execution of assigned clinical studies under the supervision of a Director/Senior Director in Clinical Development. This individual will support clinical studies in collaboration with other members of the cross-functional study team. Clinical Pharmacology studies may be in-scope based on company need.
- Provide clinical and scientific oversight of clinical study execution, from start-up to close-out and results reporting.
- Leading role in authoring clinical study protocols/amendments and related study documents (including but not limited to drug specific risk language, ICFs, clinical study training materials, pharmacy manual, laboratory manual, etc.) by translating the strategy and approved concept into executable and efficient clinical studies.
- Contribute to authoring various regulatory study documents, including clinical sections of IND/NDA and CTA submissions, investigator brochures, annual reports and updates, and clinical sections of heath authority responses.
- Develop a clinical study execution plan in collaboration with cross-functional study leads.
- Share the responsibility for establishing and maintaining regular cross-functional study team meetings with the study Clinical Operations Lead.
- Contribute to the selection and management of study vendors, including but not limited to CROs, central laboratories/imaging, clinical sites, EDC, IRT, TMF, etc.
- Train internal and/or external study team members on medical and scientific aspects of the clinical study at SIVs and at other applicable forums.
- Review and monitor emerging clinical study data related to safety and efficacy (including but not limited to establishing the medical monitoring plan, conducting medical review, and documenting the outcome of medical review).
- Work closely with the Study Medical Lead and Director/Senior Director of Clinical Development to report clinical study progress and ensure timely communication of any identified medical or operational issues.
- Proactively identify and review emerging study issues by actively engaging with study CRO, vendors, and cross-functional study leads.
- Develop sound and strategic solutions to arising study issues and collaborate with pertinent study team members to ensure issue resolution.
- Support the review, analysis, and interpretation of clinical study results.
- Contribute to clinical study report development and ensure timely finalization.
- As needed, present clinical study data to internal and/or external stakeholders.
- Maintain current knowledge of pertinent therapeutic area(s)
- Other responsibilities as assigned.
What You Bring- Degree in Life Sciences (PhD, PharmD, RN, NP) with at least 3 years of hands-on early- and/or late-stage clinical development experience in a pharmaceutical or biotechnology organization is required. Late-stage clinical development experience preferred.
- Clinical research background in metabolic diseases is preferred.
- Understanding of the drug development process from pre-IND through registration.
- Understanding of drug development functional areas, including preclinical, clinical pharmacology, regulatory, pharmacovigilance, drug supply, biometrics (data management, biostatistics, programming), and clinical operations.
- Ability to understand, interpret, and communicate clinical information including clinical study data, literature reviews, and current treatment practices to inform decision-making and clinical strategy.
- Candidates must possess effective communication and influencing skills across functions.
- Critical traits for success include strategic and proactive thinking, strong scientific and analytical skills, decisiveness and the ability to perform as a respected team member.
- Ability to work effectively in a collaborative and highly matrixed team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view.
- Independently motivated, detail oriented, and good problem-solving ability.
- Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment.
- Proficient knowledge of GCP/ICH.
- Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture.
Travel & In Office Presence You will be expected to travel periodically based on the needs of the business, including attendance at Together Weeks, Together Days, and functional meetings as requested by the team. Employees are expected to work on hybrid schedules, consistent with local office practices and the terms of the companies in office policy as in effect from time to time.
