Vice President, Product Development, CMC Small Molecules
Confidential, Dallas, TX, United States
Vice President, Product Development, CMC Small Molecules
About the Company
Accomplished biopharmaceutical company developing innovative drugs
Industry Biotechnology
Type Privately Held
About the Role
The Company is seeking a Vice President for CMC Small Molecules to provide strategic leadership in the development of small molecule pharmaceuticals. The successful candidate will be responsible for driving the CMC development process from preclinical stages to commercialization, ensuring compliance with international regulatory standards, and aligning CMC strategies with clinical and commercial objectives. This role involves overseeing the development of drug substance, drug product, and analytical processes, as well as managing partnerships with external manufacturing organizations. The VP will also be a key contributor to regulatory submissions and will lead a high-performing CMC team, fostering innovation and professional growth.
Applicants must have a Master’s degree in a relevant field, with a Ph.D. preferred, and at least 15 years of experience in CMC development for small molecule pharmaceuticals. The role requires a proven track record in advancing programs from preclinical to commercial stages, expertise in process chemistry, formulation, and analytical development, and proficiency in global CMC regulatory requirements. Strong leadership, strategic thinking, and communication skills are essential, as is the ability to mentor and inspire a team. The position also involves occasional global travel and demands a candidate with a strong background in managing external partnerships with CMOs and CDMOs.
Travel Percent Less than 10%
Functions
Product Management
About the Company
Accomplished biopharmaceutical company developing innovative drugs
Industry Biotechnology
Type Privately Held
About the Role
The Company is seeking a Vice President for CMC Small Molecules to provide strategic leadership in the development of small molecule pharmaceuticals. The successful candidate will be responsible for driving the CMC development process from preclinical stages to commercialization, ensuring compliance with international regulatory standards, and aligning CMC strategies with clinical and commercial objectives. This role involves overseeing the development of drug substance, drug product, and analytical processes, as well as managing partnerships with external manufacturing organizations. The VP will also be a key contributor to regulatory submissions and will lead a high-performing CMC team, fostering innovation and professional growth.
Applicants must have a Master’s degree in a relevant field, with a Ph.D. preferred, and at least 15 years of experience in CMC development for small molecule pharmaceuticals. The role requires a proven track record in advancing programs from preclinical to commercial stages, expertise in process chemistry, formulation, and analytical development, and proficiency in global CMC regulatory requirements. Strong leadership, strategic thinking, and communication skills are essential, as is the ability to mentor and inspire a team. The position also involves occasional global travel and demands a candidate with a strong background in managing external partnerships with CMOs and CDMOs.
Travel Percent Less than 10%
Functions
Product Management