With a successful on-market treatment and an industry-leading pipeline, our client is seeking an individual who will work closely with internal cross-functional teams to ensure clarity of strategy, to manage specific product development and major regulatory submissions (e.g., NDA, MAA), in order to advance pipeline programs on behalf of the company. The successful candidate should possess a scientific background and demonstrate understanding and experience in drug development and the regulatory requirements to plan, execute and deliver both NDAs and INDs to global regulatory authorities.
This role is highly cross-functional, and may involve close interaction with external partners. The Director of Program Management is charged with having an in-depth understanding of critical path/activities and interdisciplinary connections necessary to complete specific major regulatory submissions. The ideal candidate has strong communication skills, ensuring that all team members understand priorities, objectives, deliverables, interdependencies and timelines.
Build, drive and maintain project and major regulatory submission plans that delivers tangible results in advancing the company’ s pipeline, ultimately leading to commercial launch of key assets.
Facilitate team meetings and operational mechanisms to drive cross-functional communication, decision making, and successful execution of program plans and major regulatory submissions.
Develop and maintain detailed program and major regulatory submission milestones and oversee the process for content draft, review and delivery according to identified timeline proactively identify and prioritize program risks, and develop and monitor risk mitigation/contingency plans.
Oversee adherence to program budgets and regulatory submission project plan timelines and deadlines.
Manage interdependencies across functions, including clinical, non-clinical, regulatory and CMC to support execution of project plan and major regulatory submissions.
Lead data-driven decision-making in order to make timely, solid, objective recommendations for continuation, acceleration, reprioritization, redesign or termination of projects, along with necessary change management recommendations.
Provide periodic status reports to project executives and coordinate documentation and archiving of project deliverables
Communicate effectively to team members and executives through written, verbal and project summary updates, providing line of site to key issues and accomplishments
Demonstrated ability to drive projects to completion
BS in technical discipline, Advanced degree preferred
10+ years’ experience in Pharmaceutical industry process and regulations in a function such as clinical, CMC, quality, or regulatory affairs with significant exposure to global teams
5+ years of experience in program management/leadership of cross-functional teams
Proven ability to balance conflicting priorities across multiple programs, and to make sound recommendations for trade-offs between resources (personnel, investment, capacity) to achieve aligned corporate objectives with a “ sense of urgency”
Self-directed individual who can work both independently and through a cross-functional team in a fast-paced environment, fostering open communication, mutual understanding and cooperation within the company and with external vendors
Solution-based thinker with a “ can do”/” do-what-it-takes” attitude, coupled with superb organizational and communication skills
Strong interpersonal skills with the ability to motivate others and direct activity from a position of informal influence, negotiate during conflict situations, and forge consensus between competing points of view
Fluency with standard computer software packages (Word, Excel, PowerPoint, MS Project, PMIS)
Represents attributes reflective of company Values: Patient focused, bias for action, commitment to excellence, empowered people, and integrity.