Head of AAV Gene Therapy CMC
Proclinical is currently recruiting for a Head of AAV Gene Therapy CMC for a biopharmaceutical company located in New York, NY. Successful candidate will be responsible for leading teams dedicated to the development activities necessary to advance gene therapy programs from preclinical into Phase 1/2 clinical trials.
- Lead cross-functional teams, plan and execute a fully integrated CMC & program plans for development of the Company's bio-gene therapy programs.
- Manage the operational aspects of the program(s), including developing overall strategy, tactical implementation plans, fully integrated development plan and timelines, and monitoring key milestones and decision points to drive delivery of program objectives.
- Develop program strategy and plans, set milestones and timelines and coordinate the cross-functional activities required for drug development.
- Build and maintain strong relationships with external partners in academia and industry and coordinate communications with business partners, including academic partners and Contract Development and Manufacturing Organizations (CDMOs).
- Represents program to Senior Management while ensuring effective communication to align program activities with corporate strategy and ensure effective program execution.
- Facilitate problem-solving, contingency planning, and decision-making through proactive issue identification and contingency planning.
- Prepare presentation materials for team and stakeholders.
- Proactively identify operational and program issues and drive cross-functional resolution.
- Partner with finance to maintain accurate forecasts and ensure robust budget process.
- Lead team in the implementation of cross-functional program risk management plans including risk and opportunity identification, mitigation strategies and contingency planning.
Skills and Requirements:
- MS or PhD in Biological Sciences, Bio-engineering, Chemistry, or associated discipline. PMP Certification and/or relevant additional training is a plus.
- 10 years of experience in the biotechnology/pharmaceutical industry; early development experience (pre-IND - Phase I) preferred.
- 5+ years of experience in drug development managing multiple projects.
- Experience with gene therapy and orphan indications.
- Track record of leading and advancing projects from research into clinic including experience with IND and BLA filings.
- Experience in tech transfers, manufacturing, quality systems, CDMO management, regulatory requirements, and commercial development.
- Project Management certification preferred.
- Thorough understanding of the preclinical and early clinical development for gene therapies.
- Experience advancing gene therapy programs, including experience with CMC.
- Proven ability to manage project teams and coordinate cross-functional projects to achieve milestones and deliverables on schedule.
- Strong interpersonal and communication skills for bridging between scientific and business participants, for driving a program to effective implementation and for managing effective collaborations.
- Demonstrated team-building skills and ability to develop strong working relationships with a diverse range of collaborators.
- Excellent analytical skills with the ability to elucidate and maintain focus on key program drivers.
- Strong verbal slide and written communicator, able to concisely summarize complex technical information.
- Results driven, self-motivated, enthusiastic, and strategic with attention to detail and accuracy.
- Ability to work independently, prioritize and manage multiple tasks simultaneously.
- Proficiency with MS Project, Word, Excel and PowerPoint.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Tong at (+1) 646-878-6308 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.