Senior Scientist (Nonclinical Development) - Gene Therapy/Vector Delivery
Our client, a RTP area clinical phase company that is developing transformative gene therapies to treat Neurological disorders, is actively recruiting for a skilled and knowledgeable scientist with substantial experience in non-clinical development and particular expertise in CNS to join its R&D team.
The company’s mission is to identify, develop, and bring to market high-impact therapies that have the potential to improve the lives of patients with neurological disorders. It is motivated by the promise of novel drug development, and is combining cutting-edge gene transfer techniques, innovative vector design, and tailored delivery methods to optimize the safety, efficacy and durability of the clinical effects of its gene therapies.
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 lab-based role leading the in vivo and in vitro work supporting the gene therapy product portfolio from development through commercialization. Gene Therapy bkgd is highly preferred.
- In addition to driving non-clinical studies this Sr. Scientist will be responsible for bioanalytical assay development as well as contributing to regulatory strategies and submissions. Seek broadly-skilled candidate whose scientific core is complemented by business savvy and regulatory knowledge.
- This is a highly collaborative role in an emerging business setting. This Scientist will participate in project teams, present findings to leadership, manage outside vendors and, in general, contribute her/his scientific expertise wherever it is needed. Right candidate will be a highly skilled scientist who communicates exceedingly well, demonstrates a mission-driven work style, and is always prepared to help where the help is needed.
This Senior Scientist will be responsible for driving key functional areas including Nonclinical Studies (in particular Toxicology), as well as BioAnalytical Assay development across the R&D organization (Non-Clinical, Clinical, and CMC).
- Ensure well-designed and executed nonclinical and bioanalytical efforts for each pipeline program through all stages of development
- Provide scientific expertise for the rapid development, validation and implementation of bioanalytical assays to support non-clinical and clinical studies for gene therapy programs in development
- Provide support for regulatory filings and updates to various regulatory bodies
- Work closely with Project Management to help define goals and objectives and ensure alignment with corporate goals.
- Serve as functional representative on matrix teams representing Nonclinical and BioAnalytical areas
- Represent the company internally and externally to key stakeholders.
Targeted candidate will offer a Ph.D. or MS degree in relevant scientific discipline (e.g. neuroscience) as well as 3+ years of biotech/pharma industry research and development experience. Neuroscience bkgd is a must. Gene therapy bkgd (ideally vector delivery) is a very strong plus.
Other priorities include:
- Experience contributing non-clinical expertise to project teams
- Training and experience in toxicology studies
- Working knowledge of techniques used in neuroscience, biochemistry, and molecular biology
- Familiarity and experience with drafting and review of regulatory documents
- Polished verbal communication and interpersonal skills. This individual will represent the company at all levels of stakeholder engagement, internal and external.
Finally, this is a dynamic, empowered, collaborative and mission-driven setting. Seek insightful, self-directed and extremely competent professional who gets things done, and deftly overcomes barriers that develop.
This is an immediate need and a Direct Hire opportunity. Please forward Word resume for prompt consideration. Local candidates targeted at this time.
Please forward Word resume for prompt consideration.