VP Level Positions
We are currently recruiting for three newly created positions at the level of Vice President. There are six management employees listed on company documents as "key" employees, and we are responsible for the recruitment of three of them. Summary information is shown below.
Other positions with the same organization include:
Director or Senior Director of Statistics
Director or Senior Director of Regulatory Affairs (BLA experience is a firm requirement)
Clinical Trials Coordinator (and Administrative Assistant)
Job descriptions for the above positions will soon be posted
*Click on the position titles below to view the full job descriptions.
Reporting to the Chief Technology Officer, this is an exciting opportunity to be a key executive to lead, build and launch the company’s cGMP manufacturing organization.
The Vice President (VP) of Manufacturing will head the function ensuring that appropriate scientific, regulatory, and quality standards are followed across manufacturing facility design, construction and validation, GMP operation system establishment, collaboration with contract manufacturing organization (CMO), and commercial production management. The VP of Manufacturing will also lead CMC alliance activities as part of the global development of drug substance within the Company and with partners. The VP of Manufacturing will provide technical leadership and CMC expertise including during discussions with Global Regulatory agencies.
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.
The Vice President of Regulatory Affairs will be responsible for all Regulatory Affairs functions, including supervisory responsibility for all regional Regulatory Affairs employees reporting into this position. This position reports to the Chief Medical Officer.
Primary responsibilities include:
Develop and execute the Company’s regulatory strategy for all Research & Development ("R&D") and commercial products
Develop and guide CMC regulatory strategy; oversee compliance and serve as a true business partner to Company leadership.
Maintain and further upgrade the core competencies of the Regulatory Affairs ("RA") organization from a technical, commercial and people perspective, which includes establishing organizational commitment and a sense of urgency to drive leading projects through all development stages.
Provide regulatory strategic leadership for all drug development projects, including but not limited, to health authority submissions, interactions and other regulatory requirements in line with corporate objectives and timelines
Provide leadership, and when necessary, contribute hands-on support to the regulatory team in managing, planning, coordinating, and preparing all documents submitted to FDA and ex-US health authorities in support of INDs, BLAs, MAAs, DMFs, CTAs, amendments, safety reports, and annual updates
Develop budgets and resource forecasts for the Regulatory Team.
"Steve responded quickly to my resume submission and provided several worthwhile suggestions to make myself more marketable. He knows the industry and was able to put my resume in front of key decision makers in several pharmaceutical companies." Peter M.
"Steve was one of the most responsive recruiters I dealt with during my career search, and I have used his services more than once. I have also recommended him many times to my colleagues."