✨ Fill and validate PDF forms with InstaFill AI. Save an average of 34 minutes on each form, reducing mistakes by 90% and ensuring accuracy. Learn more

VP Global Head of Program Leadership

uniQure Lexington, Massachusetts
leadership leadership lead strategy management team medical clinical development stakeholders senior cross functional operations patients
March 16, 2023
uniQure
Lexington, Massachusetts
OTHER

VP Global Head of Program Leadership


Location:
Lexington, Massachusetts (US)
Education level:
Bachelor / Graduate



Job category:
R&D Operations
Target start date:
8/15/2022



uniQure is dedicated to bringing innovative therapies for unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.


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 uniQure 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 “One uniQure” 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 uniQure’s 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.



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


Here's What You'll Bring to the Table:



  • D, MD or MD/Ph.D. with 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


<<MINIMUM QUALIFICATIONS>>


Report this job

Similar jobs near me

Related articles