Theravance Biopharma is seeking an experienced Medical Director to join their Clinical Development and Medical Affairs department, reporting to the Head of Clinical Development and Medical Affairs, Respiratory.
• Candidates for this position will have a medical degree (MD or equivalent) and expertise in respiratory diseases such as asthma, COPD and/or cystic fibrosis.
• Experience in the design and conduct of clinical trials, particularly phase 3B and phase 4 clinical trials, health outcome trials, and trials to satisfy payer requirements is preferred.
• The candidate will be expected to provide expert scientific and clinical contributions into the design, planning, conduct, evaluation and reporting of clinical studies. This candidate will be expected to collaborate with colleagues in the Clinical Development and other company departments to assure high-quality, timely and cost-effective experiments are performed in late-stage development. The candidate should have experience or potential to serve as a team leader for cross-functional clinical development matrix teams.
• The candidate must also have experience or potential to present clinical data to internal stakeholders (project teams, senior development teams, corporate leadership teams) as well as to external audiences (external medical experts, scientific advisory panels, scientific congress attendees and regulatory agencies).
Duties and Responsibilities
The duties and responsibilities include but are not limited to the following:
• Works collaboratively with Marketing and Sales colleagues to ensure a successfully commercial operation of the company as it enters the respiratory arena.
• Works collaboratively with Biometrics, Clinical Development and Operations, Regulatory Affairs, DMPK and Project Management.
• Works to develop relationships with External Experts in the respiratory area, working with them to understand and interpret data from clinical trials, positioning of assets, approaches with payers, and current clinical practice.
• Works collaboratively with partners at Mylan, and other external partners as appropriate, to ensure the success of Theravance programs.
• Collaborates in the review of clinical trial design and protocol development within the company
• Contribute to the clinical sections of regulatory documents and meetings.
• Interact with regulatory agencies throughout the development process
• Execute and supervise clinical studies, analyze results and write study reports.
• Serve as Medical Monitor on clinical trials, and as medical expert for clinical studies
• A record of working effectively on cross-functional teams.
• Comfortable working in a fast-paced, highly dynamic, and matrix pharmaceutical company.
• MD or equivalent.
• 5+ years of experience in Medical Affairs (preferred) or Clinical Development in a pharmaceutical or biotechnology setting.
• Late-stage development experience in working in teams and in interacting with key internal and external stakeholder groups, including regulatory agencies
• Excellent oral and written communication skills. Confident using online communications and teleconferencing. Confident with Microsoft Office programs.
• Comfortable with presenting detailed scientific data to groups, large and small, internally and externally. Must also have demonstrable skills with teaching and educating both professional and lay people.
• Ability to work on several projects simultaneously.