Principal Medical Director, Neuroscience

Roche • South San Francisco, CA

4d • $241,500 - $448,500

About The Position

Roche’s Clinical Development organization develops and executes late-stage clinical strategies and plans to deliver medically differentiated therapies that meaningfully improve patients’ lives. The Principal Medical Director will join the Neuroscience, MS group and guide development within a Neuroscience portfolio. The role calls for experience in late-stage drug development, collaboration across functions, and strong knowledge of neuroscience diseases, clinical trial protocols, and regulatory requirements, including possible interactions with regulatory agencies.

The Principal Medical Director leads the Clinical Development (CD) strategy, develops the CD plan, and ensures its effective and efficient execution for assigned molecules or indications. The role acts independently as a CD leader and leads multiple projects. It involves engagement with senior management and internal and external experts, advising Roche committees, and representing therapeutic-area strategy, plans, objectives, and interests to health authorities and prominent thought leaders. The position also contributes to therapeutic-area scientific strategies and plans, oversees end-to-end drug delivery device strategy where appropriate, integrates that strategy with the clinical development plan and asset strategy, and mentors physicians and scientists in their areas of expertise.

The position may be based on-site in San Francisco, California, or Boston, Massachusetts, or remotely within the United States. Relocation benefits are not available.

Requirements

• MD, MBBS, or MD (MBBS)/PhD.
• Board certification in Neurology.
• Significant clinical trial or clinical development experience in multiple sclerosis studies.
• At least 7 years of pharmaceutical or biotechnology R&D experience across all phases of development, including work with global internal and external teams.
• Experience authoring global clinical development plans and working with health authorities, including leading successful interactions with the FDA, EMA, and other health authorities and involvement in a filing.
• Extensive understanding of Phase II–III drug development, gained through experience across development stages or formal education or qualifications in pharmaceutical medicine or drug development.
• Significant contributions to an organization’s drug development.
• Experience creating clinical development strategies that have led to label-enabling outcomes.
• Significant regulatory experience providing clinical science information and input for regulatory submissions and processes.
• Experience leading or overseeing development of briefing packages and health-authority interactions and responses, providing clinical science information and input.
• Ability to work with team members and internal partners on regulatory filings and other regulatory documentation.

Nice To Haves

• In-depth knowledge of the pharmaceutical or biotechnology industry and the functions and roles involved in drug development.
• Experience championing novel or innovative approaches to clinical development, such as study design, endpoints, or technology.
• Ability to collaborate on enterprise-level strategic initiatives with internal and external partners, including investigators, clinicians, scientists, key opinion leaders, and multidisciplinary groups across Roche/Genentech Product Development.
• Demonstrated outcomes from strategic collaborations, such as new study proposals or new disease indications.
• Contributions to the local site and global community, such as initiating or organizing events, presenting at staff meetings, identifying community initiatives, and engaging with the broader PD/GPS global community.
• Prior people-management experience.
• Outstanding interpersonal, verbal, written communication, and influencing skills.
• Experience building and cultivating important relationships inside and outside Roche and influencing internal stakeholders, thought leaders, national advocacy organizations, national standard-setting bodies, and other relevant external parties.

Responsibilities

• Lead development of the Clinical Development strategy for assigned molecules or indications.
• Develop Clinical Development plans and ensure their effective and efficient execution.
• Act as a Clinical Development leader, work independently, and lead multiple projects.
• Serve as an internal consultant to Roche committees and represent therapeutic-area strategies, plans, objectives, and interests to health authorities and prominent thought leaders.
• Provide insights and contributions to the development and effectiveness of assigned therapeutic areas, including scientific strategies and plans.
• Oversee end-to-end drug delivery device strategy for programs in the franchise where appropriate, integrating it with the overall clinical development plan and asset strategy to support execution and regulatory alignment.
• Mentor physicians and scientists in their disease areas of expertise.
• Provide clinical science information and input for regulatory submissions and processes.
• Lead or oversee development of regulatory briefing packages and health-authority interactions and responses.
• Collaborate with regulatory and other internal partners and stakeholders on regulatory filings and documentation.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• The position qualifies for company benefits, detailed at a linked benefits page; specific benefits are not listed in the posting.
• Relocation benefits are not available.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree