Objectives
- Represent, and may lead, clinical science for regional (US or other region) clinical development of assigned pipeline compounds.
- Lead a multidisciplinary, matrixed team; ensure scientific issues are considered for complex data.
- Influence creation, maintenance, and execution of a clinical development plan to support regulatory approval across multiple regions.
Accountabilities/Responsibilities
- Participate and lead clinical development teams; align US/EU activities with global strategy.
- Develop program deliverables: Development Strategy, Clinical Development Plan sections, and Clinical Protocols.
- Recommend program scope/complexity and influence budget.
- Critically evaluate and maintain state-of-the-art development strategy; identify challenges and contingency plans.
- Monitor and interpret internal/external study data; support high-impact global/regional decisions (e.g., go/no go; protocol/design modifications).
- Create and secure governance approval for synopsis/protocol development, study execution, and study interpretation.
- Lead protocol synopsis completion and obtain review committee approvals; manage IRB/Ethics documentation responses; review/interprete study data and communicate conclusions.
Trial Medical Monitoring
- Manage information for protocol conduct and subject safety; provide preliminary assessments to Medical Monitor.
- Review overall safety data with Pharmacovigilance and Medical Monitor of record.
External Interactions
- Contribute to regulatory/KOL interactions; develop company positions for briefing reports, presentations, and formal responses.
- Incorporate external advice/recommendations into clinical study/program design.
Qualifications/Skills
- BS with 6 yrs; MS with 4 yrs; PharmD with 2 yrs; or PhD with 1 yr clinical research/clinical development experience (pharma/CRO/academia).
- Strong communication, strategic, interpersonal, negotiating skills.
- Clear concise communication; proactive issue prediction and problem-solving.
- Ability to drive decisions in multidisciplinary, multi-regional matrix teams; diplomacy and influencing.
- Therapeutic area knowledge (mechanism of action), regulatory requirements, GCP/ICH; emerging research knowledge.
Benefits (explicitly listed)
- Medical, dental, vision; 401(k) with match; disability; life insurance; tuition reimbursement; paid volunteer time off; company holidays; well-being benefits; up to 80 hours/year sick time; up to 120 hours paid vacation for new hires.
Application instructions
- Apply via the application process initiated by clicking the βApplyβ button.