Clinical Development Scientist (Senior Director)

Job Responsibilities:
- Independently lead clinical execution of one or more studies; accountable for program-level clinical deliverables.
- Provide input to protocol design; lead protocol development, including amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
- Represent study team in protocol review governance; partner with Global Development Lead on study/disease area strategy; may participate in KOL and Health Authority interactions.
- Ensure Study Informed Consent Documents are developed and external stakeholder requests are addressed.
- Provide clinical guidance for the Statistical Analysis Plan and Tables, Listings, and Figures.
- Guide clinical data collection strategy, instruments, and data review plan aligned to protocol and SAP; set clinical data review strategy, review emerging data/trends, review/query data, present to stakeholders, support data issue resolution, and ensure clinical queries are addressed for database lock.
- Guide Safety Review Plan/Safety Narrative Plan; review safety data, update clinical documents, track/reconcile SAEs, lead safety discussions during Safety Review Team meetings, review safety narratives.
- Guide Risk Management Plan implementation and risk mitigation activities.
- Establish/manage External Data Monitoring Committees and Adjudication Committees.
- Develop site selection criteria; provide clinical input to site selection; ensure protocol training delivery.
- Plan and deliver protocol training for investigators and ongoing updates.
- Serve as primary clinical point of contact for protocol questions; manage clinical response development, documentation, and curation (e.g., FAQ).
- Ensure protocol deviation categories, reporting, management/reconciliation, and deviation trend review.
- Ensure TMF compliance for clinical documents; provide input/review of Clinical Study Report.
- Ensure disclosure of safety/efficacy data and trial conclusions; may contribute to publications.
- Support audits/inspections and address findings.
- May contribute to regulatory filings (e.g., Briefing Documents, Investigator Brochure, IND/NDA Annual Reports, PSURs, Health Authority responses).
- Lead continuous improvement/process enhancement for clinical trial execution.
- May supervise/mentor others.

Basic Qualifications:
- PhD, PharmD, or equivalent with 7+ years; or MA/MS with 10+ years; or BA/BS with 12+ years of clinical research experience in biopharmaceutical industry.

Preferred Qualifications:
- Cardiometabolic disease experience.
- Biopharmaceutical clinical research experience across design/start-up/conduct/close-out, including regulatory submissions/inspections.
- Publications/posters/abstracts/presentations.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP.
- Clinical/administrative/project management; strong verbal/written communication.
- Experience launching/managing/training clinical development teams.
- Track record coordinating and executing clinical development.
- Ability to prioritize, manage cross-functional teams, and define/manage resources.
- Leadership skills: mentoring/coaching, conflict resolution, decision ownership, negotiating, and escalation.