Medical Director - Clinical Development

About the role

The Roche Clinical Development organization develops and executes late-stage (Phase 2-3) clinical strategies and plans for its molecules and indications. The Medical Director takes part in building the Clinical Development (CD) strategy and plan and ensures its effective and efficient execution for the assigned molecule(s) and indication(s). This is an entry-level PD Clinical Director position, so Medical Directors are still developing their knowledge of clinical studies and the pharma/biotech industry.

Key responsibilities

• Take part in developing the CD plan for the assigned molecule(s) and indication(s), gathering and analysing the data needed for it
• Work with Clinical Science Team members and sub-teams on analytics/data strategy, KOL development, publications strategy and budget/resource needs
• Keep up to date with internal and external trends affecting the assigned therapeutic areas and take part in competitive intelligence and market assessments
• Collaborate with clinical investigators, clinicians, scientists, KOLs and internal groups such as research, business development, commercial operations and legal
• Provide clinical science input to early development and Phase I/II studies, and help move new drugs and indications into Medical Affairs studies
• Take part in designing and running clinical studies, product safety profiles, investigator brochures and communications strategies, including investigator meetings, advisory boards and congresses
• Present internally and externally, review medical and safety data, monitor study progress and interim reporting, and act as a medical monitor for assigned studies
• Support regulatory activities such as briefing packages, responses to health authority questions, regulatory filings and label and packaging language
• Support training of new Clinical Science Team members and take part in cross-functional sub-teams

Required profile

• M.D. degree required
• Relevant clinical, scientific or clinical trial/development experience in the same or similar therapeutic area
• 2 or more years of post-graduate academic or clinical experience
• Academic or teaching background is a plus
• Preferred: experience publishing in a peer-reviewed journal and knowledge of GCP, ICH, FDA and EMA guidelines

Required skills

• Working knowledge of the pharma/biotech industry and the drug development process
• Strong written and oral communication, presentation and negotiation skills
• Ability to prioritise, make trade-off decisions and work in a team