ProClinical is advertising a vacancy for a Director, DMPK position with a fully integrated end-to-end clinical and commercial solution organisation. Joining the organisation's office in France, the successful applicant will work with a company that addresses current market realities through clinical and commercial sharing expertise, data, and insights to meet the needs of emerging and large global biopharmaceutical companies.
The Director of the company's DPMK will establish the Drug Metabolism and Pharmacokinetics (DMPK) strategy and deliver high quality results and interpretations in the field of Pharmacokinetics, drug metabolism, and Bioanalysis of small and large molecule drugs in therapeutic areas of interest. They will also represent DMPL in the Translational Sciences Team and with the company, support business development, and be fully engaged with clients.
- Developing the DPMK strategy, including activities associated with understanding the absorption, distribution, metabolism, and elimination properties of small molecule drugs as well as biologics in the key areas of interest (dermatology, immuno-inflammation, CNS, and oncology).
- Coordinating and supervising studies, data analysis, and their interpretation.
- Ensuring high quality reports are delivered to clients in due time and within the budget limits.
- Promoting the implementation of Model Based Drug Development approaches.
- Supervising, coaching, and mentoring DMPK staff; anticipating evolutions, proposing, and ensuring organizational changes within the DMPK team.
- Establishing the organizational structure in order to achieve expected results.
- Performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures, and Operating Guidelines and performing other duties as assigned by management.
- Ensuring good functioning of the exchanges with internal stakeholders such as Translational Pharmacology team, within the Translational Sciences and Early Phase, as well as in other parts of the organisation.
- Proposing measures aimed at optimising plans and/or shortening timelines.
- Proposing and preparing internal and external communications related to DMPK,
- Ensuring accurate cost forecasting and budget follow up for the DMPK Team.
- Developing key performance and productivity indicators to evaluate team efficiency and client satisfaction with respect to DMPK production.
- Ensuring survey of the competition in the domain.
- Identifying key differentiation factors and promoting their implementation.
- Analysing external opportunities; proposing and contributing to the management of strategic external collaborations.
- Acting as DMPK Expert for the Translational Sciences Group and providing high level expertise in PK processes.
- Ensuring the effective participation of DMPK team members in the Translational Sciences project teams.
- Supporting business development and meet with customers.
- Contributing to the design of evaluation plans for drug candidate selection and alternative strategies for clients.
- Approving quotes prepared by functions for the client projects.
- Overseeing the development of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, creating development plans, mentoring, and coaching
- Defining objectives for the DMPK team, set priorities and schedule activities.
Skills and Requirements:
- Master Degree in Science or PhD or MD, PharmD or an equivalent combination of education, training and experience.
- At least 10 years of relevant work experience (DPMK, PK and Bioanalysis).
- Relative alternate certification or experience may be considered acceptable.
- Experience in management of staff.
- Experience in translational pharmacology and/or translational medicine.
- An in-depth understanding and knowledge of the pharmaceutical/biotechnology industry in general, and the SMID community specifically.
- Experience within a client-service environment, either in a contract laboratory or within a core group at a pharmaceutical company.
- Working knowledge of GLP/ICH guidelines and other applicable regulatory requirements.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Chidozie Orji at +44 207 440 0671 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.