About the position
Roche's Product Development (Late Stage, Clinical Development) organization is organized by therapeutic area and plays a critical role in shaping and executing clinical strategies that bring medically differentiated therapies to patients. This is an exciting period of growth and innovation at Roche. Within the Immunology Therapeutic Area, we are dedicated to advancing B-cell directed therapies for autoimmune diseases. As part of our expanding efforts, we're thrilled to introduce a newly created Principal Medical Director position to support our growing Rheumatology pipeline. The Principal Medical Director will help develop and execute a strategy to maximize the benefit of our pipeline assets for patients with autoimmune disease. This person will lead development of the Clinical Development (CD) strategy and is responsible for ensuring effective and efficient execution for assigned molecule(s)/indication(s). A Principal Medical Director is expected to act as a clinical development leader, perform their responsibilities independently, and effectively lead multiple projects. Principal Medical Directors may be assigned CD strategy development and implementation oversight for an entire therapeutic area. Principal Medical Directors are expected to successfully mentor other medical directors and/or scientists in their disease area of expertise.
Responsibilities
- Lead, delegate and be responsible for the development and implementation of the CD strategy and/or plan for assigned molecule(s)/indication(s).
- Represent CD for the assigned molecule(s)/indication(s) to other internal Roche groups.
- Ensure cross-functional integration, coordination and alignment to enable effective and efficient CD plan execution.
- Collaborate with internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs).
- Participate in meetings, reviews, discussions and other interactions regarding early development studies to provide clinical science input and guidance.
- Lead or oversee others in development of briefing packages, responses to health authority questions, and health authority interactions.
- Consult to pharma partnering on relevant acquisitions, joint ventures or other strategic partnerships.
Requirements
- MD/MBBS with relevant clinical, scientific and development experience in rheumatology, specifically late stage experience in systemic lupus erythematosus and/or lupus nephritis.
- Extensive experience working with the principles and techniques of data analysis, interpretation, and clinical relevance.
- 8+ years of pharma/biotech R&D experience; with demonstrated experience in late stage clinical development.
- Proven track record of effective decision making skills.
- Demonstrated experience as a cross functional project team lead.
- Demonstrated experience authoring a global clinical development plan.
- Demonstrated level of knowledge of Phase II - III drug development.
- Experience publishing results of a clinical trial in a peer-reviewed journal.
- Strong level of knowledge of the pharma/biotech industry and the drug development process.
- Outstanding written and business presentation skills.
- Aptitude or proven ability to mentor colleagues and foster their successful career development.
- Ability to travel up to 30% globally.
Nice-to-haves
- Demonstrated interpersonal, verbal, and written communication and influencing skills.
- Demonstrated experience working with various health authorities/regulatory agencies.
- Ability to prioritize multiple tasks and goals on time, on target, and within budget.
- Demonstrated competence when interacting with others at all levels.
- Impeccable ethics and alignment to Roche values.
Benefits
- Relocation benefits will be offered for this position.
- Discretionary annual bonus may be available based on individual and Company performance.
