Description
Your impact:
In this enterprise leadership role you will lead a cross-functional team to develop the integrated development plan for RAP-314, a foundational program in the company’s pipeline, a program with the potential to improve the lives of millions of patients living with pain and create significant value for RAPP.
Your day-to-day:
Serve as the single accountable leader for RAP-314 from early-stage development through through Phase 2/3 and registration.
Opportunity to shape and lead integrated development plan for RAP-314 from IND through product approval.
Define and drive the integrated development strategy, ensuring alignment with target product profile, global regulatory expectations, and corporate goals.
Lead program-level decision-making, risk assessment, and scenario planning in coordination with senior leadership.
Lead and align cross-functional teams including clinical, regulatory, CMC, biometrics, and medical affairs.
Provide innovative and flexible operational solutions and options to the cross functional and development teams; assist in preparing scenarios for creative solutions to operational challenges.
Oversee timelines, budgets, and resources across functions to ensure milestones are met.
Oversee preparation of key regulatory filings (IND amendments, End-of-Phase 2 meetings, NDA/MAA submissions).
Represent the program in regulatory agency meetings alongside clinical and regulatory leads.
Present program updates, timelines, risks, and mitigation plans to the executive leadership team, board of directors, and investors.
Build strong relationships with key internal stakeholders and external partners (CROs, CDMOs, consultants, etc.).
Requirements
Must-Haves:
PhD, PharmD, MD, or equivalent advanced degree in a relevant scientific or clinical field.
15+ years of biotech/pharmaceutical industry experience, with proven leadership in small molecule drug development.
Significant experience leading cross-functional programs through early and middle stages of development (Phase 1/2) and toward regulatory approval.
Demonstrated success in program leadership roles, particularly startup biotech environments.
Strong understanding of regulatory pathways and expectations for small molecule therapeutics.
Exceptional interpersonal, communication, and influencing skills.
Experience managing complex timelines, budgets, and partner relationships.
Familiarity with working across multiple geographies (e.g., US and EU regulatory bodies).
Experience managing/mentoring in a highly matrixed environment
