Job Information
Genentech, Inc. Principal Medical Director, Product Development, Cardiovascular in Newark, New Jersey
The Position
We advance science so that we all have more time with the people we love.
The Opportunity
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 Cardiovascular, Renal, and Metabolism group. The role of Principal Medical Director will focus on guiding the development of cardiovascular drugs, specifically by leading the design and execution of large cardiovascular outcome studies. The ideal candidate would be a cardiologist with extensive experience in drug development and managing large-scale clinical trials, particularly in the later stages of development.
The Principal Medical Director will have strong collaboration with cross-functional teams, including clinical research, regulatory affairs, and product development, to ensure the successful progression of treatments through the pipeline and into the market. The position would also require a strong understanding of cardiovascular 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. Principal Medical Directors may be assigned CD strategy development and implementation oversight for an entire brand or franchise.
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 mentor other physicians / scientists in their disease area of expertise.
This position offers the flexibility to work onsite at one of our US Genentech/Roche locations, with the option for remote work also being a possibility.
No relocation benefits will be provided for this position.
Who You Are
(Required)
You have an MD or MD/PhD, board eligible/board certified in cardiology; along with significant clinical trial/development experience in cardiovascular studies, preferably phase 3 cardiovascular outcome studies.
You have 8+ years of pharma/biotech R&D experience,
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 PD, 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.
This position offers the flexibility to work onsite at one of our US Genentech/Roche locations, with the option for remote work also being a possibility.
No relocation benefits will be provided for this position.
The expected salary range for this position based on the primary location of South San Francisco, CA is between $269,920 - 501,280. 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, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.
Roche is an Equal Opportunity Employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.