Phone: (267) 387-0090
Position Overview
Reporting to the President of R&D, this highly visible role will be the “Player-Coach” for our newly formed Program Leadership function. We are seeking a highly motivated, strategic and energetic Program Leader to lead our core teams in the strategy and execution of the development programs from Pre-IND, through proof of concept and registration. The successful candidate will work closely with the VP of Clinical Operations, Clinical Development and Program Management to develop a strategy and to ensure project execution. They will also ensure that best practices and key learnings are shared between core teams.
The successful candidate will work independently and thrive in a proactive, can-do “our client” culture. The VP, Global Head of Program Leadership needs to be a highly effective internal and external team player with excellent communication skills who can influence laterally and navigate numerous stakeholders across multiple time zones. Our core teams will almost always be comprised of members from across the U.S. and Europe.
The VP, Global Head of Program Leadership will be the Program Leader for our client lead clinical program. They are also tasked with hiring the Program Leader for our next clinical pipeline projects and continue to scale the team as the pipeline progresses.
Job Responsibilities
- Act as a “CEO” for clinical programs and late preclinical programs, fostering a sense of mission, creativity and urgency.
- Work with the team and with senior leaders to develop a program strategy and plan scenarios and trade-offs.
- Form a close partnership with department leads and with program management to build program plans, identify risks, manage budgets, and timelines and ensure best practices.
- Represent the program to internal and external stakeholders.
- Work closely with the President of R&D and with other senior leaders to align the programs with the mission of the company.
- Lead key program team meetings and serve as a point of escalation for the program to executive leadership.
- Help build best practices for efficient and effective program teams.
- Support development of regulatory documents and FDA and EMA interactions.
- Engage external stakeholders including advisory boards and KOLs.
- Develop and maintain the Integrated Development Plan for the program.
- Work with clinical development, medical affairs, CMC and commercial leaders to integrate clinical plans with late-stage development activities like investor communications, patient reported outcomes, and health-economics research.
- Work with corporate affairs on investor communications and patient advocacy
Job Requirements
- D, MD or MD/Ph.D.
- 6+ years of experience in a biotechnology or pharmaceutical setting
- Experience in CNS and/or Liver drug development including the translation of novel candidates from preclinical to clinical development.
- Experience developing regulatory documents and strategy.
- Experience in clinical drug development.
- Experience in CMC ideally in gene therapy or biologics.
- Proven track record of successful cross functional program leadership or management supporting early- and late-stage programs
- Strong ability to lead cross-functional teams; engage senior leadership, health authorities, and KOLs
- Prior experience managing or working within cross-functional project teams with timeline management and budgetary responsibility
- Must be adept at working in a fluid environment that fosters a strong collaborative spirit and a sense of mission.
- Strong written and oral communication skills as well as demonstrated organizational aptitude
Location(s)
If interested, please send a MS Word version of your resume to [email protected]
Submit Your Résumé
