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Vice President of Preclinical Development

Reference Number: 2924
Location: MA

Our client is a rapidly growing biotechnology company.  They have asked us to assist them in their search for a Vice President of Preclinical Development.

The Vice President of Preclinical Development will be responsible for all aspects of preclinical development in order to advance drug candidates from late stage discovery to the clinic.  This individual will provide scientific and drug development leadership in a matrix role to an interdisciplinary drug development team comprising internal and external contributors.  The incumbent will provide guidance to project managers during the discovery phase of the lead programs and then take responsibility for the design and execution of IND-enabling studies during preclinical development.  Responsibilities will include, but are not limited to, timeline management, identification of project risks and contingency planning, preparation of study/program related materials, and supervision of internal activities and CRO study related activities through IND, and IND assembly and submission.

Major tasks and responsibilities will include:

  • Plays a critical role in developing and advancing corporate mission and strategic direction.  Participates in key decisions impacting the future of the company.
  • Provides leadership to the overall strategic planning and successful implementation of multiple preclinical and development programs through matrixed program teams.
  • Operates as the line manager for a high caliber scientific team responsible for advancing portfolio through late pre-clinical development/translational medicine.   Plays a critical role in attracting, retaining, grooming, and advancing key players.
  • Ensures highest caliber of internal staff and effective network of outside partners, collaborators and service organizations.
  • Contributes to discovery efforts by providing guidance, support and decision making to the discovery project managers.
  • Initiates and manages relationships with third parties such as KOLs and academic partners in specific disease areas to develop a high-level target product profile and help align discovery and preclinical development activities to the ultimate clinical endpoints.
  • Leads the effort in generating and obtaining consensus on the criteria for nomination of a drug candidate to preclinical development.
  • Accountable for the ADME/PK and Toxicology studies to enable nomination of a candidate for preclinical development and for IND submission.  Single point of accountability for generating, tracking, and delivering timely, cost-effective and high quality program milestones and regulatory filings on schedule and budget.
  • Participates in the evaluation, selection and management of CROs, contractors, and vendors.
  • Manages overall preclinical development operations, project resources, budget and timelines for all assigned programs.
  • Develops and maintains effective working relationships with internal team and external partners.
  • Reports to the CSO.

We seek candidates with the following qualifications:

  • PhD or PharmD is required for this position with at least ten years of development experience and managing preclinical operations.
  • Excellent management skills and business acumen.  Evidence of the ability to lead and inspire high-performance teams.
  • Impressive track record of delivering outstanding results including the successful filing of multiple INDs.
  • Experienced leader in the transition of discovery programs into clinical development.
  • Knowledge and experience in the evaluation of the PK and safety profile of oligonucleotides.
  • Highly organized and able to prioritize and handle multiple tasks simultaneously.
  • Detailed knowledge of the drug development process, Good Laboratory Practices and FDA regulatory requirements.
  • Ability to independently solve problems related to CRO monitoring and management.
  • Experience building and leading an excellent preclinical development function, including outsourcing components and including organizational design and the recruitment, development and retention of a first-rate team.
  • Experience building and managing collaborations with scientists, CROs, consultants, pharmaceutical partners and other outside organizations.
  • Large and small company experience and work experience in a fast-paced, entrepreneurial environment.
  • Experience with conducting preclinical studies leading to successful IND submission.
  • Experience in the development of oligonucleotide drug candidates is strongly preferred.
  • Strong project management experience.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2924. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.