Medical Director
Job Title: Medical Director
Department: Clinical Development
Reports to: Chief Clinical Development Officer/CSO
As Clinical Research Physician/Medical Director you will be responsible for providing medical and scientific leadership for the successful execution, and reporting of the medical aspects of clinical trials. Additionally, this role acts as the internal medical expert and will serve as a medical resource for the team and contribute to the growth and development of the company's organization. This is a hands-on role working with experienced colleagues as part of a cross-functional team.
Major Accountabilities:
Provides medical strategic input to the assigned project or section of a clinical program including:
*Providing medical oversight of outsourced study conduct including interactions with CRO medical and drug safety teams.
*Providing medical input to operational team, including review of documents and plans, e.g CRFs, medical monitoring plans, laboratory manuals, deviation management plans etc.
*Performing medical data review to maintain oversight of emerging efficacy and safety profile as well as potential quality issues for designated trials.
*Working closely with the Drug Safety function to evaluate Serious Adverse
*Events and to develop Safety Management Plans, Pharmacovigilance Plans and Risk Management Plans.
*Ensuring adequate safety overview and medical monitoring of the trial.
*Organizing and support DMCs as well as you assure compliance with ICHGCP and other regulatory requirements
*Driving development of clinical sections of trial and program level regulatory documents (e.g., protocols, Investigator's Brochure updates, safety updates, Clinical Study Reports, and responses to Health Authorities).
*Working cooperatively with Clinical Operations and designated CROs to execute the programs (e.g. participate in study start up, and cross-functional team meetings, perform data and coding reviews; draft/present clinical slides for Investigators Meeting, Advisory Boards and therapeutic/monitor training etc.)
*Creating and approving internal and external training materials and processes.
Ideal Background
*Medical Doctor with a minimum of 5 years of professional experience in the field of clinical research with a biotech or pharmaceutical company.
*Board certified in the field of Dermatology and/or Rheumatology would be a plus and/or relevant professional experience in drug development.
*A good understanding of clinical drug development and GCP is required for this position.
*Being experienced in interactions with national supervisory authorities (e.g. EMA, FDA, BfArM) is a plus.
*Demonstrated ability to independently evaluate, interpret and present complex scientific data.
*Demonstrated ability to critically evaluate complex drug development programs.
*Demonstrated ability to work within a multi-disciplinary team of peers and outside experts.
*Possess an organizational and planning talent with excellent communication skills (written or spoken).
