Overview
The Principal Medical Director, Product Development, CVRM role focuses on guiding the development of Roche’s CVRM portfolios within the Cardiovascular, Renal, and Metabolism group. The position requires extensive late-stage drug development experience and management of large-scale clinical trials, with collaboration across clinical research, regulatory affairs, and product development to advance treatments through the pipeline to the market. The role leads the Clinical Development (CD) strategy and plans for assigned molecule(s)/indication(s) and may oversee strategy development for an entire brand or franchise.
Responsibilities
* Interact with senior management and external experts, serving as internal consultants to Roche committees and representing the therapeutic area’s CD strategy, plans, objectives, and interests to health authorities and thought leaders.
* Provide critical insights to the development and effectiveness of the assigned therapeutic areas, including scientific strategies and plans.
* Demonstrate experience in Clinical Development Plan (CDP) Strategy & Planning, CDP Execution, Regulatory Activities, and Cross-Functional Team Leadership.
* Mentor other physicians/scientists in their disease area of expertise.
Who You Are
* MD, MBBS or MD (MBBS)/PhD with significant clinical trial/late-stage development experience; preferably in CVRM studies.
* 8+ years of pharma/biotech R&D experience.
* Experience authoring global clinical development plans and interacting with health authorities (e.g., FDA, EMA) including filings.
* Extensive understanding of Phase II–III drug development and contributions to an organization’s drug development and label-enabling outcomes.
* Regulatory experience: providing clinical science input for regulatory submissions, leading the development of briefing packages and responses to HA questions, and coordinating regulatory filings.
Preferred
* Board eligible/certified in cardiology or endocrinology preferred.
* In-depth knowledge of the pharma/biotech industry and drug development processes.
* Championed innovative approaches to clinical development (study design, endpoints, technology).
* Ability to collaborate on enterprise-level strategic initiatives with a variety of partners and stakeholders; demonstrated outcomes such as new study proposals or disease indications; active involvement in the broader PD/GPS community.
* Prior people management experience.
* Strong interpersonal, verbal, and written communication skills; ability to influence internal and external partners.
Location and Benefits
This is an on-site position based in Boston, MA, South San Francisco, Basel, CH, or Welwyn, UK. Boston, MA is preferred. Relocation support is provided. Salary range for Boston, MA is $253,500 - $471,000; actual pay determined by experience, qualifications, location, and other factors. A discretionary annual bonus may be available. This position qualifies for the benefits described in the linked candidate resources.
Employment Type and Seniority
* Seniority level: Director
* Employment type: Full-time
* Job function: Health Care Provider
Genentech is an equal opportunity employer. If you have a disability and need accommodations for the online application process, please contact us via the Accommodations for Applicants form.
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