Director, PCS Scientific Projects
The Director, PCS Scientific Projects serves as the key strategic leader accountable for the development and execution of strategic options of the assigned preclinical portfolio.
- Provides expertise and consultation for multiple drug candidates through all phases of preclinical development.
- Ensures that the Preclinical Safety strategy is aligned closely with clinical and regulatory development strategy.
- Other areas of responsibility include interfacing and consulting on the strategy with PCS Directors.
- Provides vision and leadership to ensure the successful execution of preclinical activities in the early and late development stages.
Key Responsibilities Include :
- Drives and oversees assigned TA portfolio(s) for multiple indications and across multiple NCE's and NBE's.
- Sets long range (5 year) vision and strategy for preclinical operations as related to their assigned portfolio.
- Provides direct people leadership and oversight to assigned scientific staff in the development and execution of PCS studies. Indirectly supports study directors and staff assigned to studies within their TA.
- Establishes high performance standards within the assigned portfolio. Identifies gaps in performance and intervenes as warranted to reach performance standards.
- Represents TA and preclinical safety in governance reviews and provides technical expertise in the development of preclinical safety plans
- Directs and oversees the execution of preclinical program(s) within a therapeutic area.
- Builds and maintains high-performing preclinical program management teams ensuring alignment of individual goals within the assigned portfolio.
- Interacts with appropriate PCS and non-PCS teams and take an active role in the planning of safety studies. Interacts with individuals from PCS operations departments (Toxicology, Pathology, Comparative Medicine) to ensure quality guidelines and timelines are met.
- Anticipates and resolves scientific challenges.
- Selects, develops and mentors direct reports in scientific and administrative responsibilities.
- PhD in Science or related field, DVM or PharmD with at least 10 years of related work experience.
- Ability and past experience in developing and executing therapeutic area strategy.
- Advanced scientific knowledge; evidence of publications and presentations within the area of relevance.
- Ability to think beyond current practices to advance molecules through the approval process.
- Experience in leading multi-disciplinary groups; ability to interface effectively within a matrix organization.
- Understanding of preclinical safety operations (Comparative Medicine, Toxicology, Pathology) as it relates to the role of the study director.
- Experience in providing advice and influence without authority to teams across multiple geographic areas and organizations
Equal Opportunity Employer Minorities/Women/Veterans/Disabled