Senior Director/VP Nonclinical & Bioanalytical Development - Gene Therapy

Job Type: 
Life Sciences
Other Life Science Positions
Professional Services
Other Professional Positions
Employment Category: 
Direct Hire

Our client, a RTP area clinical phase company that is developing multiple cutting-edge gene therapies to treat Neurological diseases, is actively recruiting for an exceedingly knowledgeable and capable scientific leader to drive non-clinical and bioanalytical development.  This is an essential role in a company doing important work.  Compensation will be generous

Key Things to Note:

  • The company is advancing three clinical candidates through various phases of development, all in the CNS space.  Neuroscience bkgd and knowledge will be important.
  • This is a high profile, high impact role.  The Senior Director /VP (client is open to both levels) will be a visible and vocal spokesperson providing scientific and strategic input in shaping the R&D and Business Development strategy with primary responsibilities in nonclinical, bioanalytical and translational research. Gene Therapy bkgd is expected.
  • This Sr. Director/VP will be instrumental in regulatory strategy and submission.  Seek candidate who brings an understanding of the regulatory landscape as well as successful experience moving products through IND/NDA submission/approval.
  • This is a hands-on leadership role in an emerging business setting.  Right candidate will be a collaborator who complements broad and deep scientific credentials and know-how with a flexible, mission-driven, get-it-done work style.  Experience directing the efforts of CROs and other partners is expected and required.

Selected Responsibilities:

  • Design and execute all Safety (PCS), Pharmacokinetic Sciences (PKS) and design and develop Bioanalytical methods supporting Nonclinical/Clinical activities
    • Lead the functional units to ensure well-designed and executed nonclinical and bioanalytical efforts for each pipeline program through all stages of development
  • Oversee final design, protocol development, execution, monitoring, and reporting of all pharmacology, biodistribution, PK/PD and dose range-finding studies with company gene therapies
  • Actively contribute to regulatory document creation and review. Represent the company during engagement with various regulatory authorities
  • Lead partnering and collaborations in the advancement of our therapeutic targets
  • Provide strong scientific expertise leading the rapid development, validation and implementation of bioanalytical assays to support non-clinical and clinical studies for gene therapy programs in development
  • Design and oversee the execution of safety and tolerability aspects of translational research programs to support clinical stage programs
  • Stay current on industry trends and standards and promote a culture of Good Research Practices within the company
    • Demonstrate expertise in GLP compliance, current bioanalytical regulatory guidance and implementation of industry best practices
    • Demonstrate knowledge of standard and novel assay platforms to enhance efficiency and scientific quality of assays Qualifications
    • Develop and maintain world-leading expertise and recognition in CNS gene therapies as an emerging therapeutic modality

Target candidate will offer a Ph.D. or equivalent advanced degree in relevant scientific discipline (e.g. neuroscience, biochemistry, cell biology) as well as 10+ years of biotech/pharma industry research and development experience. Strong preference for expertise in neuroscience and/or gene therapy.

Other priorities include:

  • Substantial expertise leading non-clinical and bioanalytical functions noted above including pharmacology, biodistribution, PK/PD, etc.  Current knowledge of industry trends, novel assay platforms, etc.
  • Demonstrated ability to significantly contribute to business development, feasibility and regulatory strategy efforts
  • Experience as a study director, principal investigator and/or study monitor for pharmacology/toxicology studies. Preferably in gene therapies and Central Nervous System disorders
  • Outstanding project management, team leadership and collaboration skills.  Seek a skilled leader of cross-functional teams
  • Advanced written communication skills. Specifically, in drafting and review of regulatory documents. 
  • Polished, professional and nuanced verbal communication and interpersonal skills. This individual will represent the company at all levels of stakeholder engagement, internal and external.
  • Record of impact, achievement and longevity

Company is prepared to pay top dollar -- designed to attract and retain the best. Any package will include a generous base, bonus, equity and benefits.  Local candidate preferred.

Please forward Word resume for prompt consideration.