Senior Medical Director, Product Development, Neurology

Roche • Boston, MA

4d • Onsite

About The Position

The Senior Medical Director leads the development of the Clinical Development (CD) strategy and plan and is responsible for ensuring effective and efficient execution for the assigned molecule(s)/indication(s). This role involves leading, delegating, and being responsible for the development and implementation of the CD strategy and/or plan for assigned molecule(s)/indication(s). The Senior Medical Director will represent CD for the assigned molecule(s)/indication(s) to other internal Roche groups and will be responsible for ensuring cross-functional integration, coordination, and alignment to enable effective and efficient CD plan execution. Collaboration 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 PD, research, business development, commercial operations, and legal, is expected. The role may involve participating in meetings, reviews, discussions, and other interactions regarding early development/Phase I studies to provide clinical science input and guidance, including reviewing and providing late-stage input into Phase I and II protocols. The Senior Medical Director will lead health authority (HA) interactions, including the development of briefing packages by providing clinical science information and input. They will take a lead role with other CST members, regulatory, and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation, providing clinical science information and input for regulatory submissions and other regulatory processes. This includes developing label and packaging language, etc. The Senior Medical Director will be accountable for training new CST members.

Requirements

• Board Certified/Board Eligible (or its equivalent) MD (MBBS), MD(MBBS)/PhD trained Neurologist
• 6+ years of pharma/biotech R&D experience and/or is recognized as an expert in your field
• Ability to effectively contribute to pipeline strategy and lead cross-functional teams
• Late stage experience within the Neurology space
• Experience working with various health authorities
• Demonstrated ability to work with pharma partnering on relevant acquisitions, joint ventures or other strategic partnerships
• Significant experience designing and conducting clinical trials (i.e. one or more trials)
• Demonstrated experience in late stage development
• Proven ability to use sophisticated analytical thought, identify innovative approaches and act as a mentor
• Demonstrated ability to foster and promote a highly productive and inclusive team-based culture in fast-paced clinical and/or research settings
• Significant experience working with the principles and techniques of data analysis, interpretation and clinical relevance
• Demonstrated experience in scientific writing (e.g. manuscripts, grants, scientific protocols, health authority documents)
• Outstanding communication skills in both long-form scientific presentation and short-form communication of complex scientific topics
• Demonstrated ability to collaborate with relevant team members to measure and monitor study progress against objectives and plans, including any variances, and proactively communicate any issues, challenges and potential strategies to resolve
• Experienced working with various clinical trial designs

Nice To Haves

• Demonstrated clinical experience within multiple sclerosis
• Leadership experience
• Strong interpersonal skills: Outstanding interpersonal, verbal, and written communication and influencing skills
• Have built and cultivated important relationships both inside and outside of the organization and externally
• Proven abilities to influence internal partners and stakeholders, thought leaders, national advocacy organizations, national standard-setting bodies, and other relevant external parties
• Seamlessly collaborates with colleagues/other parts of the organization

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 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 PD, research, business development, commercial operations, legal, etc.
• Participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input and guidance; includes reviewing and providing late stage input into Phase I and II protocols
• Lead health authority (HA) interactions, including the development of briefing packages by providing clinical science information and input
• Take a lead role with other CST members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation, providing clinical science information and input for regulatory submissions and other regulatory processes
• Develop label and packaging language, etc.
• Be accountable for training new CST members

Benefits

• Relocation benefits are not being offered for this position.
• 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.

What This Job Offers

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