Job: Senior Director/VP Nonclinical & Bioanalytical Development - Gene Therapy, Frankel Staffing Partners, RTP, NC
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.
- 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 askilled 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.
Frankel Staffing Partners proudly recruits on behalf of premier employers in the Triangle (and beyond). We specialize in Office Support, Life Science and other Professional Services positions. To view our current openings, please visit our website at www.frankelstaffing.com.