Sr. Distinguished Scientist - PSTS Neuroscience Disease Area Lead

About the Role

The PSTS Disease Area Lead (DAL) (TA arena: Neuroscience) is a scientific leader assigned specifically to a disease area and has responsibility for bringing disease area strategic pipeline knowledge back to PSTS and PSTS teams, end-to-end (discovery through registration). The PSTS DAL along with the PSTS Modality Lead are the primary interfaces between the PSTS organization and leaders in the therapeutic areas (TA) as well as other TA-facing partners in other organizations (e.g. Regulatory affairs, Global Medical Safety, Clinical Pharmacology).

The DAL's primary accountability is for disease-specific scientific strategy and risk stewardship across the portfolio, assuring discovery ROPs and competitive development ADPs that incorporate disease area specific considerations and requirements through a PSTS lens. They will own and evolve strategic project planning frameworks (class risks, translational signals, and platform learnings) and assure PSTS programs are planned consistently across the disease area.

• Interact with TA leadership in appropriate TA and governance forums and as needed to stand in as delegate for PSTS GLT on projects & strategy discussions in TA area.
• With the PSTS modality lead(s), be accountable for recommendations for diligence in TA disease area spaces and for strategic planning in partnership with specific PSTS laboratory functional leaders and external CRO partners.
• Serve as a coach and mentor for PSTS team leaders working in their portfolio, providing expert advice and review of PSTS plans and regulatory submissions at assigned stages and PSTS functional reviews.
• Maintain scientific depth and expert working knowledge of competitive intelligence and regulatory landscape in TA arena; track milestones, issues, and attrition and highlight strategic gaps in PSTS for action.
• May serve as the PSTS team lead as needed.
• Sit as a member of the extended PSTS portfolio leadership team and lead or participate in special strategic projects as needed.
• Drive strategic planning for PSTS preparedness to operate in the designated therapeutic disease area space, including PSTS discovery project plans and development ADPs.
• Provide executive level updates to management, fostering cross-functional cohesion, cross-industry activities and forums with regulators and external experts.

Required Education and Experience

• Ph.D. in scientific discipline with 10+ years of experience or equivalent industry expertise.
• Knowledge of pharmaceutical science and drug development strategies in modality space.
• Experience developing and implementing scientific and effective PSTS and project team plans per modality strategies, including target areas, TPPs, and ADPs.
• Knowledge of regulatory requirements and expectations for first-in-human approval or registration of therapeutics in modality space.
• Strong verbal and written communication skills appropriate for executive and highly visible external venues.
• Experience in effective coaching.
• Strong organizational skills and team leadership.
• Ability to effectively deliver impact through matrix leadership and network well with cross-functional peers.
• Maintain strong external visibility to ensure strong external reputation for PSTS.
• Deep scientific understanding of neuro discovery and development.

Preferred Education

• Ph.D. plus dual advanced degree such as MD, DVM, or equivalent advanced training.
• Relevant board certifications such as DABT, DACVP, or equivalent.
• Experience with discovery and development of molecules via regulatory path for modality arena.
• Experience in dealing with FDA or other regulatory interactions and practice in working with clinicians.
• Experience in diligence space.
• Experience supporting neuro governance decisions, regulatory interactions, and/or external diligence for relevant therapeutic programs.

Expected travel: 20% domestic and international.