The Director, DMPK, will be responsible for managing and supervising the scientific, administrative, and technical activities related to Drug Metabolism laboratories of DMPK function of Early Drug Development. This person will be responsible for managing In Vitro & In Vivo Drug Metabolism and Drug-Drug Interaction studies conducted within the Corporation
and studies outsourced to CROs, and ensuring compliance of all regulations as appropriate. This individual will provide Drug Metabolism expertise on behalf of the company and represent the Corporation with the appropriate academic centers and various regulatory authorities. This person will also be responsible for assisting the line management in establishing and achieving long-term Corporate Strategic goals and tactical objectives.
Oversee quality, quantity, and performance time for Drug Metabolism studies, and continuously improve the performance and productivity of the functional group.
Ensure that studies are conducted in a timely manner and in compliance of all regulatory requirements.
Plan, develop and control expenses, capital and personnel requirements for the respective functional group.
Assist DMPK and EDD line management in establishing long term goals, formulating plans of action for achievement of goals, and the assessment of success.
Contribute to the interactions with regulatory authorities, as appropriate, for resolving issues relating to DMPK studies.
Represent DMPK on R&D Project Teams and contribute to the advancement of projects.
Responsible for recruiting, mentoring, guiding and retaining junior scientific staff.
Responsible for evaluating the performance of subordinate staff and taking an active role in their technical and career advancement.
Ensure that EDD Department maintains current awareness in the area of expertise, enhance the scientific credibility of the company through contributions to the scientific literature (publications/presentations), through extramural activities and scientifically related interactions with academic and health authorities.
Assumes shared responsibility for authoring summary documents for submission to regulatory agencies (INDs, NDAs).
Ph.D. with 10+ years of industry experience in DMPK and an excellent understanding of the drug development process.
Proven record of extensive scientific accomplishments including regulatory submissions, publications, as lead author, in peer-reviewed journals is necessary.
Advanced knowledge of regulatory and standard industrial practices in DMPK.
Excellent managerial, leadership and supervisory skills.
Excellent communication skills to effectively represent the DMPK at internal working groups/project teams and external academic/industrial/regulatory organizations.
Team player, mentoring and leadership abilities.
The incumbent must have planning skills for scheduling activities and meeting corporate and project team deadlines. The position requires problem solving ability, people management ability and skills in resolving technical questions in a multi-disciplinary environment. The incumbent must keep abreast of best practices within the industry and the various scientific and regulatory areas in drug metabolism and analytical methodology.