Senior Medical Director, Product Development, CVRM

The Position

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

The Senior Medical Director leads 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). Senior Medical Directors are expected to perform their responsibilities independently, and effectively lead multiple projects. Our late stage, 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.

• You will lead, delegate and be responsible for the development and implementation of the CD strategy and/or plan for assigned molecule(s)/indication(s); you will represent CD for the assigned molecule(s)/indication(s) to other internal Roche groups; you will be responsible for ensuring cross-functional integration, coordination and alignment to enable effective and efficient CD plan execution

• You will 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.

• You may 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

• You will lead health authority (HA) interactions, including the development of briefing packages by providing clinical science information and input; you 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. Includes developing label and packaging language, etc.

• You will be accountable for training new CST members

This role is based in Boston, MA (USA).
Relocation benefits are being offered for this role.

Who You Are:
(Required)

• You are a Board Certified/Board Eligible (or its equivalent) MD (MBBS), MD(MBBS)/PhD trained Gastroenterologist/Hepatologist, Endocrinologist or Cardiologist

• You have 6+ years of pharma/biotech R&D experience and/or is recognized as an expert in your field; you can effectively contribute to pipeline strategy and lead cross-functional teams.

• You have late stage experience within the CVRM space and have worked with various health authorities.

• You have demonstrated the ability to work with pharma partnering on relevant acquisitions, joint ventures or other strategic partnerships

• You have significant experience designing and conducting clinical trials (i.e. one or more trials)

• You have demonstrated experience in late stage development; you have the proven ability to use sophisticated analytical thought, identify innovative approaches and act a mentor

• You have demonstrated the ability to foster and promote a highly productive and inclusive team-based culture in fast-paced clinical and/or research settings

• You have significant experience working with the principles and techniques of data analysis, interpretation and clinical relevance, and demonstrated experience in scientific writing (e.g. manuscripts, grants, scientific protocols, health authority documents)

• You have outstanding communication skills in both long-form scientific presentation and short-form communication of complex scientific topics

• You have demonstrated the 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,…