Medical Director, Clinical Pharmacology
Debiopharm Group™ is a Swiss-based global biopharmaceutical group of five companies active in the development and manufacture of drugs and diagnostics tools. Debiopharm focuses on developing prescription drugs that target unmet medical needs. The group in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.
For our Clinical Pharmacology & Drug Metabolism team in the Translational Medicine department based in Lausanne we are looking for a: MEDICAL DIRECTOR, CLINICAL PHARMACOLOGY(100% - permanent contract)
In this role, you will be responsible for the clinical pharmacology program of Debiopharm’s projects, leveraging state-of-the-art PK and PK/PD methodologies. You will lead the clinical strategy and deployment of the early phases in healthy volunteers.
Your main responsibilities:
- Responsible for the scientific/medical/technical aspects of assigned healthy volunteers clinical pharmacology studies from conception through final report, including first-in-human studies (SAD, MAD), clinical drug-drug interaction, TQT, special populations PK and ADME studies; provides also his/her medical expertise for clinical pharmacology aspects of oncology projects.
- In collaboration with Clinical Operations and Program Medical Director when applicable, conduct and monitor drug safety in early clinical phases and in late clinical pharmacology studies in healthy volunteers.
- Collaborates with Clinicians, Biostatisticians, Translational Medicine, Clinical Operations and Regulatory functions to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes.
- Develop, in collaboration with the relevant functions within Translational Medicine and Clinical Research & Development, the methodology for safety monitoring in clinical trials.
- Determine, in collaboration with the relevant functions within Translational Medicine, clinical dose selection and dose adjustment.
- Be a member of the project team and work in a collaborative and proactive way in a matrix environment.
- Responsible for authoring and reviewing documentation intended for regulatory submissions, including the relevant sections of INDs and NDAs.
- Responsible for identifying, overseeing and managing external vendors and consultants supporting the clinical pharmacology function.
- Liaises with KOLs and academic collaborators on state of the art clinical pharmacology science and methodology.
- Identifies and communicates potential project hurdles, suggests solutions and establishes priorities and contingency plans,
- Ensures the successful preparation and presentation of all internal and external documentation relating to clinical pharmacology.
- M.D., with focus in clinical pharmacology, pharmacokinetics, or a related field
- At least 5-8 years of direct experience in Biotech/Pharmaceutical industry
- Proven track-record in early clinical phases of drug development, clinical pharmacology, clinical research concepts and practices, PD and clinical PK and/or contribution to drug development programs that resulted in one or more marketed drugs, Expertise in hepatic and cardiac safety management
- Hands-on experience in authoring regulatory documentation and experience in attending regulatory meetings
- Experience with PK and PK/PD data analysis OR experience in antibacterial/ anti-infective drug development and/or in clinical pharmacology programs of oncology drugs
- Excellent leadership, management, collaboration, communication and decision making skills
Debiopharm can offer you:
- An international and highly dynamic environment, with a long term vision
- The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry
- The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success