Principal Medical Director, Neuroscience

Physician Pivot; Los Angeles (CA); À distance; USD 242 000 - 449 000; Plein temps

Résumé du poste

Roche is seeking a Principal Medical Director to guide late-stage neuroscience development, contribute to global CD strategy, and lead cross-functional teams. The role requires extensive regulatory experience and a track record of successful interactions with health authorities.

The position may be based on-site in San Francisco, CA or Boston, MA, or remote within the US, with mentorship responsibilities and strategic oversight across multiple programs in the neuroscience portfolio.

Qualifications

• MD, MBBS or MD (MBBS)/PhD, Board Certified in Neurology.
• 7+ years pharma/biotech R&D across all development phases.
• Experience authoring global clinical development plans and interacting with health authorities (FDA/EMA).
• Deep understanding of Phase II–III drug development and regulatory submissions.
• Experience leading cross-functional teams and regulatory strategy.

Responsabilités

• Interact with senior management and external experts as internal CD consultants.
• Provide insights to strengthen therapeutic area scientific strategies and plans.
• Lead CDP strategy, planning, and execution for assigned molecules/indications.
• Oversee end-to-end device strategy within clinical development where applicable.
• Mentor physicians and scientists in disease areas of expertise.

Connaissances

Cross-functional leadership

CD strategy & planning

Regulatory interactions

Clinical development leadership

Mentorship & people management

Interpersonal communication

Formation

MD/MBBS or MD/PhD, Board Certified in Neurology

Description du poste

The Position

We advance science so that we all have more time with the people we love.

Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development clinical strategies and plans that deliver medically differentiated therapies that provide meaningful improvement to patients.

Roche is looking for an experienced and highly specialized individual to join the Neuroscience, MS group. The role of Principal Medical Director will focus on guiding the development within one of our Neuroscience portfolios. The ideal candidate will have experience in late stage drug development and a demonstrated level of collaboration experience with cross-functional teams. The Principal Medical Director position requires a strong understanding of neuroscience diseases, clinical trial protocols, regulatory requirements, and possibly interactions with regulatory agencies to ensure studies meet the required standards.

The Principal Medical Director leads development of the Clinical Development (CD) strategy and is responsible for developing the CD plan and ensuring effective and efficient execution for assigned molecule(s)/indication(s). Principal Medical Directors are expected to act as CD leaders, perform their responsibilities independently, and effectively lead multiple projects.

• You will interact with the highest levels of management and experts both internally and externally, serving as internal consultants to Roche committees as well as representing the therapeutic area’s CD strategy, plans, objectives and interests to health authorities (HAs) and prominent thought leaders.
• You are expected to provide critical insights and contributions to the overall development and effectiveness of the assigned therapeutic area(s), including therapeutic area scientific strategies and plans. .
• You have demonstrated a high level of experience in Clinical Development Plan (CDP) Strategy & Planning, CDP Execution, Regulatory Activities, and Cross-Functional Team Leadership.
• You will oversee the end-to-end (E2E) drug delivery device strategy (where appropriate) for programs in your franchise and ensure each strategy is integrated within the overall clinical development plan and asset strategy for the assigned molecule to ensure seamless execution and regulatory alignment.
• You will mentor other physicians / scientists in their disease area of expertise.

This position will be based on-site in San Francisco, CA; Boston, MA or remotely within the US.

Relocation benefits are not available for this role.

Who You Are

(Required)

• You have an MD, MBBS or MD (MBBS)/PhD, Board Certified in Neurology; along with significant clinical trial/development experience in MS studies.
• You have 7+ years of pharma/biotech R&D experience across all phases of development; including experience working with global teams internally and externally
• You have experience authoring global clinical development plans and working with various health authorities; (i.e. have led successful interactions with the FDA, EMA and other health authorities, including a filing.)
• You have extensive understanding of Phase II – III drug development (e.g trials across different stages of development, or formal education/qualifications in pharmaceutical medicine or drug development); have made significant contributions to an organization’s drug development (whether at Roche or another organization); have identified and created clinical development strategies that have led to label-enabling outcomes
• You have significant regulatory experience: providing clinical science information and input for regulatory submissions and other regulatory process: experience leading/overseeing others in development of briefing packages by providing clinical science information and input; experience leading/overseeing others in development of interactions and responses to health authority (HA) questions by providing clinical science information and input; other team members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation

Preferred

• You have in-depth knowledge of the pharma/biotech industry, the multiple functions and roles involved in the drug development process.
• You have championed novel/innovative approaches to clinical development (i.e. study design, endpoints, technology)
• You have the ability to collaborate on enterprise level strategic initiatives with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups in the Roche/Genentech Product Development team: research, business development, commercial operations, legal, etc, resulting in demonstrable outcomes (e.g. new study proposals or new disease indications) and make major visible contributions to the local site community and the PDC global community, e.g. initiates, organizes, and participates in special events, presents and promotes discussion at All Staff meeting, proactively identifies new initiatives to enhance the community; is highly visible to the broader PD/GPS global community.
• You have prior people management experience.
• You have strong interpersonal skills: outstanding interpersonal, verbal, and written communication and influencing skills: have built and cultivated important relationships both inside and outside of Roche; have proven abilities to influence internal partners and stakeholders, thought leaders, national advocacy organizations, national standard-setting bodies, and other relevant external parties.

The expected salary range for this position based on a primarily remote US based location is $241,500 - $448,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.