Job: VP of Drug Development, Full Scale Solutions, Inc., Raleigh, NC
VP of Drug Development
Raleigh, NC 99999 United States
Commensurate upon experience.
Overall responsibility for drug substance and drug product activities transitioning from preclinical development through clinical supplies for Phase 3 registration studies and eventual transition to commercial supply
Provide guidance and direction for project strategy, goals, budgets and other operational activities.
Is the senior technical leader for the CMC Team, integrating internal and external team members’ activities into the pharmaceutical development plan and presents plans and progress to the Senior Leadership Team.
Identification, selection and management of Contract Manufacturing Organizations (CMOs) for process optimization, cGMP manufacture and supply of Drug Substance (DS) and Drug Product (DP) for both small and large molecule development programs
Develop and implement a strategy for optimizing and controlling quality and with using CROs and CMOs
Delivery of robust, scalable and cost-effective manufacturing routes and drug product formulations appropriate for use in clinical trials
Develop material needs for all pre-clinical and clinical activities and manage the resulting budgets and timelines
Collaborate with the clinical team to establish and ensure a solid supply chain for clinical trial materials
Direct efforts to implement stage appropriate analytical methods and protocols to ensure CROs/CMOs are using systems and processes in compliance with all relevant regulatory standards
Through CROs and CDMOs, execute plans for the validation and registration of DS and DP as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations
Accountable for all CMC associated regulatory and quality documents associated with INDs, NDAs, and other regulatory submissions and documentation; represent the company as the Pharmaceutical Development expert before U.S. and European regulatory authorities
Assists in the development of and ensures compliance of Company, site, and safety policies and procedures.
Ph.D. with 10+ years of experience in a pharmaceutical or biotechnology CMC/cGMP environment; Advanced degree in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, Chemical Engineering or related discipline
Extensive experience in managing the US and International CRO/CMOs for the manufacture of cGMP DS and DP
Substantial experience with projects in late pre-clinical and clinical development (Phase 1 through Phase 3)
Experienced with cGMP manufacturing and IND, CTA and NDA filings; thorough knowledge of relevant FDA and EMEA regulations
Proven track record of superior interpersonal and communication skills with the ability to develop a strong positive relationship with senior management as well as all levels of the organization.
Embrace the following values in all decision making across the organization:
Collaboration, Patient Focus, Innovation, Uncompromising Integrity, and Excellence.
Ability to operate effectively within an entrepreneurial and science-driven company environment; self-motivated, delivery-oriented, assertive, able to inspire others, driven and hands-on with unquestionable integrity and the highest ethical standards
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