Medical Director
- Cambridge
- Permanent
- Full-time
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 ICH-GCP 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.
- Minimum of 5 years of professional experience of clinical research within a biotech or pharmaceutical company ideally in Dermatology/Rheumatology/Inflammatory diseases.
- Experience of regulatory drug development requirements in US and EU markets.
- Previous experience of interactions with national supervisory authorities (e.g. EMA, FDA) is a plus.
- 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.
- 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).
- 2 days a week in our brand new Cambridge or Porto Office(s)