Clinical Sciences Associate Director
Novartis
20 days ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Key Responsibilities:
- Serve as Study Leader and/or Clinical Scientist for predominantly high-complexity, global studies; provide additional Clinical Sciences support as needed.
- Independently lead clinical protocol development with the Medical Lead and other line functions; author clinical protocols/amendments and contribute to medical/scientific inputs and study-level regulatory document sections.
- Develop strategic/scientific input into study concept, feasibility, and execution; develop and implement study-level operational execution plans with cross-functional partners.
- Collaborate with cross-functional partners to identify and select high-performing sites to meet recruitment commitments.
- Lead a global Clinical Trial Team (CTT) to ensure trial deliverables are met; set stretch goals and timelines and propose alternatives to accelerate timelines.
- Partner with line functions to align and manage internal/external stakeholder expectations.
- Lead ongoing medical/scientific review of trial data: safety trend analysis, signal detection, interpretable results, Clinical Study Reports (CSRs), and internal/external publications.
- Prepare and lead dose escalation meetings; coordinate real-time availability of quality data for dose escalation and Phase II reviews.
- Lead risk mitigation and trial-level risk management implementation.
- Forecast and manage overall study budget(s); collaborate on vendor strategy and timelines.
- Implement trial management best practices/standards and share lessons learned; represent initiatives and may serve as Subject Matter Expert.
- Support talent development: hiring/interview/onboarding/mentoring; line manage assigned associates and support retention/career growth.
Essential Requirements:
- Bachelor’s in life science/healthcare required; PhD/MD/PharmD/Master’s preferred.
- 8+ years’ experience in clinical trials/development.
- High learning agility across therapeutic areas.
- Ability to drive complex collaborations amid unpredictability and rapid change.
- Demonstrated leadership/influence, strong interpersonal, and stakeholder management skills.
- Strong tolerance for ambiguity; adapt, speak up, and challenge.
Application Instructions:
- None stated in the provided text.
- Serve as Study Leader and/or Clinical Scientist for predominantly high-complexity, global studies; provide additional Clinical Sciences support as needed.
- Independently lead clinical protocol development with the Medical Lead and other line functions; author clinical protocols/amendments and contribute to medical/scientific inputs and study-level regulatory document sections.
- Develop strategic/scientific input into study concept, feasibility, and execution; develop and implement study-level operational execution plans with cross-functional partners.
- Collaborate with cross-functional partners to identify and select high-performing sites to meet recruitment commitments.
- Lead a global Clinical Trial Team (CTT) to ensure trial deliverables are met; set stretch goals and timelines and propose alternatives to accelerate timelines.
- Partner with line functions to align and manage internal/external stakeholder expectations.
- Lead ongoing medical/scientific review of trial data: safety trend analysis, signal detection, interpretable results, Clinical Study Reports (CSRs), and internal/external publications.
- Prepare and lead dose escalation meetings; coordinate real-time availability of quality data for dose escalation and Phase II reviews.
- Lead risk mitigation and trial-level risk management implementation.
- Forecast and manage overall study budget(s); collaborate on vendor strategy and timelines.
- Implement trial management best practices/standards and share lessons learned; represent initiatives and may serve as Subject Matter Expert.
- Support talent development: hiring/interview/onboarding/mentoring; line manage assigned associates and support retention/career growth.
Essential Requirements:
- Bachelor’s in life science/healthcare required; PhD/MD/PharmD/Master’s preferred.
- 8+ years’ experience in clinical trials/development.
- High learning agility across therapeutic areas.
- Ability to drive complex collaborations amid unpredictability and rapid change.
- Demonstrated leadership/influence, strong interpersonal, and stakeholder management skills.
- Strong tolerance for ambiguity; adapt, speak up, and challenge.
Application Instructions:
- None stated in the provided text.