Clinical Sciences Associate Director
Novartis
5 months ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Key Responsibilities:
- Study Leader and/or Clinical Scientist for predominantly high complexity, global studies; provide additional Clinical Sciences support to high priority, high complexity, global studies.
- Independently lead clinical protocol development with the Medical Lead and other line functions; serve as responsible author for clinical protocols/amendments; contribute medical/scientific input to study documents/processes and to clinical sections of study-level regulatory documents.
- Develop strategic and 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 select strategic, 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, manage realistic planning/timelines, and propose alternatives to accelerate timelines.
- Partner with line functions for input/alignment; manage internal and external stakeholder expectations.
- Lead ongoing medical/scientific review of clinical trial data across assigned studies; support data analysis/interpretation (including safety trend analysis, signal detection, first interpretable results), prepare CSR outputs, and support internal/external publications.
- Prepare and lead dose escalation meetings; coordinate real-time availability of quality data for dose escalation and Phase II data reviews.
- Proactively lead trial-level risk mitigation, risk management, and implementation.
- Forecast and manage overall study budgets in collaboration with partners.
- Collaborate to set vendor strategy and timelines for assigned studies.
- Implement best practices and standards for trial management; share lessons learned; represent group on initiatives and may serve as Subject Matter Expert.
- Contribute to staff talent and career development (hiring/interview/onboarding/mentoring).
- Line manage assigned associates; accountable for talent attraction/retention and career growth.
- May deputize for manager upon request.
Essential Requirements:
- Bachelor’s in life science/healthcare required; Advanced degree preferred (PhD/MD/PharmD/Masters).
- 8+ years’ experience in clinical trials/development.
- High learning agility across multiple therapeutic areas.
- Ability to drive complex collaborations through unpredictable circumstances and fast-paced changes.
- Leadership/influence: foster positive work environment, mutual respect, innovation, and accountability.
- Strong interpersonal skills; proven ability to interact/influence broad stakeholder groups.
- Strong organizational awareness and stakeholder management.
- Tolerance for ambiguity; ability to adapt, speak up, and challenge.
Benefits (explicitly stated):
- Performance-based cash incentive; depending on level, eligibility for annual equity awards.
- Comprehensive US benefits package (health, life, disability; 401(k) with contribution/match).
- Generous time off (vacation, personal days, holidays, and other leaves).
- Study Leader and/or Clinical Scientist for predominantly high complexity, global studies; provide additional Clinical Sciences support to high priority, high complexity, global studies.
- Independently lead clinical protocol development with the Medical Lead and other line functions; serve as responsible author for clinical protocols/amendments; contribute medical/scientific input to study documents/processes and to clinical sections of study-level regulatory documents.
- Develop strategic and 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 select strategic, 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, manage realistic planning/timelines, and propose alternatives to accelerate timelines.
- Partner with line functions for input/alignment; manage internal and external stakeholder expectations.
- Lead ongoing medical/scientific review of clinical trial data across assigned studies; support data analysis/interpretation (including safety trend analysis, signal detection, first interpretable results), prepare CSR outputs, and support internal/external publications.
- Prepare and lead dose escalation meetings; coordinate real-time availability of quality data for dose escalation and Phase II data reviews.
- Proactively lead trial-level risk mitigation, risk management, and implementation.
- Forecast and manage overall study budgets in collaboration with partners.
- Collaborate to set vendor strategy and timelines for assigned studies.
- Implement best practices and standards for trial management; share lessons learned; represent group on initiatives and may serve as Subject Matter Expert.
- Contribute to staff talent and career development (hiring/interview/onboarding/mentoring).
- Line manage assigned associates; accountable for talent attraction/retention and career growth.
- May deputize for manager upon request.
Essential Requirements:
- Bachelor’s in life science/healthcare required; Advanced degree preferred (PhD/MD/PharmD/Masters).
- 8+ years’ experience in clinical trials/development.
- High learning agility across multiple therapeutic areas.
- Ability to drive complex collaborations through unpredictable circumstances and fast-paced changes.
- Leadership/influence: foster positive work environment, mutual respect, innovation, and accountability.
- Strong interpersonal skills; proven ability to interact/influence broad stakeholder groups.
- Strong organizational awareness and stakeholder management.
- Tolerance for ambiguity; ability to adapt, speak up, and challenge.
Benefits (explicitly stated):
- Performance-based cash incentive; depending on level, eligibility for annual equity awards.
- Comprehensive US benefits package (health, life, disability; 401(k) with contribution/match).
- Generous time off (vacation, personal days, holidays, and other leaves).