Vice President of R&D, #0226
(Cell or Gene Therapy)
Note: The position of Director or Sr. Director of R&D, #0231 is also available. The job description may be found at: #0231 - Dir/ Sr. Dir. - R&D
Location: Montgomery County area of Maryland
Company: Well established (the late 1990s) biopharmaceutical company
Focus: Regenerative therapies - cell therapy
Misc: There are eight key management employees listed at this company and we are responsible for the recruitment of three of them
Reporting to the Chief Technology Officer, this is an exciting opportunity to be a key executive to lead and organize the company’s product pipeline and research organization. The VP/Director of R&D will lead research project management and collaborate with a contract research organization (CRO) while ensuring the appropriate scientific, regulatory, and quality standards.
Our client organization is expanding the product pipeline into other applications of their lead product, including spine disc, rheumatoid arthritis, meniscus and animal osteoarthritis. The VP/Director of R&D will lead research alliance activities as part of the global development of products within the Company and external partners and will provide technical leadership and research expertise.
The primary responsibilities include management of research projects and developing a research partnership strategy to support a growing portfolio. This role will interface extensively with the discovery, quality, regulatory and program management functions.
The ideal candidate will have proven experience leading an excellent research organization. He/she will also have in-depth drug development experience, knowledge of biologics, and excellent management skills.
He/she will be part of a cross-functional team that will be responsible for all stages of drug development including proof-of-concept (POC) and preclinical studies. She/he will be highly motivated, have superior communication and organizational skills, a high level of discipline and be able to work both independently and in a team environment. This is a “roll up your sleeves”, hands-on position.
Essential Duties & Responsibilities
Manage research project to expand product applications including spine disc, meniscus, rheumatoid arthritis, and animal osteoarthritis.
Identify potential research projects to expand product pipeline with technical assessment.
Support the management of intellectual property IP portfolio and additional applications.
Oversee the preparation and management of research project plans, budgets, and long-range planning.
Collaborate with R&D team members to negotiate and administer contracts. Collaborate with other functions on research project matters (e.g., Quality, Regulatory Affairs, Commercial).
Provide guidance, mentoring, and staff development; ensure the team has appropriate skills, capabilities, and resources to meet current and future business needs. Build the function to support ongoing organizational needs.
Provide scientific guidance and oversight while factoring in technical, regulatory, and intellectual property considerations and risk assessment.
Ensure all research and development activities related to product development are completed in accordance with quality and regulatory expectations to support quality and relevant global regulatory submissions.
Support R&D team members in the management of Contract Research Organizations (CMOs), contractors, consultants, suppliers, and all outsourced contract research activities. Ensures the selection of appropriate collaborators and oversee their subsequent technical management to ensure competence and data integrity through all stages of development.
Review Technical/Quality agreements to ensure that outsourced activities are conducted in compliance with quality requirements.
Participate in regulatory strategy development, providing scientific input to and support for the compilation of regulatory submissions required for clinical trial and marketing applications.
Present R&D information and research plans/updates to the Executive Leadership Team, the Board of Directors, and business partners, as required.
Education & Experience
MS or Ph.D. in biology, pharmaceutical sciences, chemical engineering, or related scientific discipline
A minimum of 15 years of R&D and/or project management experience in the pharmaceutical industry, particularly for biologics.
Leadership and managerial experience with a team of R&D scientists, leading cross-functional projects, planning and delivering results within project deadlines. Participation in portfolio decision-making in a smaller biotech organization is preferred.
Demonstrated ability to identify and assess research projects
Demonstrated ability to build effective relationships across global internal and external organizations, preferably with experience in a matrix environment. Experience working successfully with an external business partner (US, EU, etc.) is highly desirable.
Frequent travel is required to attend meetings and conferences. Some non-standard work hours e.g. evening work will be required.
NEXT STEP OPTIONS:
Should you elect to send your resume to us, we will never forward it to anyone without first contacting you and receiving your approval to do so.
NOTE: This is an unofficial document prepared by S L Collins Associates, Inc. to provide basic information concerning the position. The company we are conducting this search for has the official job description.
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