Key Responsibilities:
- Serve as Study Leader and/or Clinical Scientist for predominantly high complexity, global studies; provide additional Clinical Sciences support to high priority studies.
- Independently lead clinical protocol development in collaboration with the Medical Lead and other line functions; author clinical protocols and amendments; contribute to clinical sections of study-level regulatory documents.
- Develop strategic/scientific input for study concept, feasibility, and execution; develop and implement study-level operational execution plans with key cross-functional partners.
- Collaborate with cross-functional partners to identify/select high-performing sites to meet recruitment commitments.
- Lead a global cross-functional Clinical Trial Team (CTT) to ensure trial deliverables are met; set stretch goals, drive realistic planning/timelines, and propose alternatives to accelerate timelines.
- Lead ongoing medical/scientific review of clinical trial data, including safety trend analysis, signal detection, first interpretable results, Clinical Study Report (CSR) reporting, and internal/external publications.
- Prepare and lead dose escalation meetings; coordinate real-time availability of quality trial data for dose escalation and Phase II data reviews.
- Lead trial-level risk mitigation, risk management, and implementation.
- Forecast and manage overall study budget(s).
- Collaborate with partners to set vendor strategy and timelines.
- Implement trial management best practices/standards; share lessons learned; represent group on initiatives; may serve as Subject Matter Expert.
- Contribute to talent development: support hiring/interview/onboarding and mentoring; line manage assigned associates.
- May deputize for manager upon request.
Essential Requirements & Qualifications:
- Bachelorβs in life science/healthcare required; PhD/MD/PharmD/Masters preferred.
- 8+ yearsβ experience in clinical trials/development.
- High learning agility across multiple therapeutic areas.
- Ability to drive complex collaborations amid unpredictable circumstances and rapid change.
- Demonstrated leadership and influence; strong interpersonal and stakeholder management skills.
- Strong organizational awareness.
- Tolerance for ambiguity; adapt; speak up and challenge.