Clinical Sciences Associate Director
Novartis, Cambridge, MA, Hybrid
Clinical ResearchBachelor RequiredExecutive Director
About the role
Job Description Summary
#LI-Hybrid Location: Cambridge The Clinical Sciences Associate Director may provide clinical leadership and strategic input for all clinical deliverables across assigned indication/program or studies within BR. May act as Focus/Disease/Platform Area Lead. May function as a Core Project Team member for assigned projects to drive the Research-Development- Commercial (R-D-C) continuum. May co-lead project clinical sub-team and reports study/project progress and issues with their resolution plan to project teams and stakeholders. Directs early stages of study design and operational plansJob Description
Key Responsibilities:- Study Leader and/or Clinical Scientist for predominantly high complexity, global studies and may provide additional Clinical Sciences support to high priority, high complexity, global studies.
- Independently lead the clinical protocol development process in collaboration with the Medical Lead and other line functions; responsible author for clinical protocols, amendments, etc.; contribute to the medical/scientific input given for the development of study-related documents and processes which reside in other line functions; contribute to the development of clinical sections of study-level regulatory documents.
- Lead development of strategic and scientific input into study concept, feasibility, and ability to execute; develop and implement study-level operational execution plan in partnership with key cross functional partners, if applicable.
- Collaborate with key cross functional partners to identify and select strategic and high performing sites to ensure recruitment commitments are met.
- Lead a global cross functional Clinical Trial Team (CTT) to ensure all trial deliverables are met; set stretch goals, promote realistic planning and timelines, and presents actionable alternatives to accelerate timelines.
- Partner with line functions to gain input and alignment and manages internal and external stakeholder expectations.
- Lead the ongoing medical/scientific review of clinical trial data across assigned studies in collaboration with the medical expert and key line functions, and partners on data analysis and data interpretation, including safety trend analysis, signal detection, development of first interpretable results, reporting clinical study results in Clinical Study Report (CSR), and internal/external publications.
- Prepare and lead dose escalation meetings with investigators. Coordinate the real time availability of quality clinical trial data, to provide consolidated information for dose escalation meetings and Phase II data reviews with relevant stakeholders.
- Proactively lead risk mitigation discussions, risk management and implementation at the trial level.
- Responsible and accountable for forecasting and managing overall study budget(s) in collaboration with key partners.
- Collaborate with key partners to set vendor strategy and timelines for assigned studies.
- Responsible for implementation of best practices and standards for trial management, including sharing lessons learned. Represent group on initiatives; may serve as Subject Matter Expert
- Contribute to talent and career development of staff. In collaboration with the relevant manager, contribute to hiring/interview/onboarding and mentoring process for new hires.
- Line management of assigned associates. Accountable for talent attraction and retention; supporting career growth and development.
- May deputize for his/her manager upon request.
- Bachelors in life science/healthcare required; Advanced degree or equivalent education/degree in life sciences/ healthcare preferred (PhD/MD/PharmD/ Masters).
- 8+ years’ experience in clinical trials/development.
- Demonstrates high learning agility in multiple therapeutic areas.
- Demonstrated knowledge and ability to confidently drive complex collaborations through unpredictable circumstances and higher paced changes.
- Demonstrates leadership and influence by creating a positive work environment by inspiring and encouraging mutual respect, instills innovation and accountability on a functional and trial level.
- Strong interpersonal skills with a proven track record of successfully interacting with and influencing with a wide range of people, building strong positive relationships.
- Demonstrates strong organizational awareness and stakeholder management skills.
- Demonstrate strong tolerance for ambiguity, willingness to adapt, and willingness to speak-up and challenge.