Principal Medical Director, Neuroscience

Genentech • Los Angeles, 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 leads the Clinical Development strategy and plan for assigned molecules or indications and ensures effective, efficient execution. The Principal Medical Director acts independently as a Clinical Development leader and leads multiple projects. The position involves working with senior management and internal and external experts, consulting to Roche committees, and representing therapeutic-area strategy and objectives to health authorities and prominent thought leaders. The role also contributes to therapeutic-area scientific strategies and plans, oversees end-to-end drug delivery device strategy where appropriate, and mentors physicians and scientists in their disease area 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 and 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 experience working with global teams internally and externally.
• Experience authoring global clinical development plans and working with health authorities, including leading successful interactions with the FDA, EMA, and other authorities and a filing.
• Extensive understanding of Phase II–III drug development, gained through trials at different development stages or formal education or qualifications in pharmaceutical medicine or drug development.
• Significant contributions to an organization’s drug development and experience creating clinical development strategies that led to label-enabling outcomes.
• Significant regulatory experience providing clinical science information and input for submissions and other regulatory processes.
• Experience leading or overseeing development of briefing packages and health authority interactions and responses, and working with team members and internal partners on regulatory filings and documentation.

Nice To Haves

• In-depth knowledge of the pharmaceutical or biotechnology industry and the functions and roles involved in drug development.
• Experience championing innovative clinical development approaches, including 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 teams.
• Record of demonstrable outcomes from collaborations, such as new study proposals or disease indications.
• Contributions to the local site community and global product development community, including organizing or participating in events, presenting at staff meetings, identifying community initiatives, and engaging with the broader community.
• Prior people-management experience.
• Outstanding interpersonal, verbal, written communication, and influencing skills.
• Experience building relationships and influencing internal partners, thought leaders, advocacy organizations, standard-setting bodies, and other relevant external parties.

Responsibilities

• Lead development of Clinical Development strategy and plans for assigned molecules or indications.
• Ensure effective and efficient execution of Clinical Development plans.
• Independently lead multiple projects and serve as a Clinical Development leader.
• Serve as an internal consultant to Roche committees and represent the therapeutic area’s Clinical Development strategy, plans, objectives, and interests to health authorities and prominent thought leaders.
• Contribute insights to the development and effectiveness of assigned therapeutic areas, including scientific strategies and plans.
• Oversee end-to-end drug delivery device strategy where appropriate, integrating it with the clinical development plan and asset strategy and ensuring regulatory alignment.
• Mentor physicians and scientists in their disease area of expertise.
• Lead or contribute clinical science information and input for regulatory submissions, briefing packages, health authority interactions and responses, and regulatory filings and documentation.
• Collaborate with cross-functional internal and external teams on clinical development and strategic initiatives.

What This Job Offers

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