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 plans
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.
Don't want to miss the next one?
Subscribe to daily email alerts for roles matching your interests.
- 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.
Essential Requirements:
- 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.
The salary for this position is expected to range between $152,600 and $283,400 per year.
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
To learn more about the culture, rewards and benefits we offer our people click here.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
