Lead Medical Director, Product Development, Hematology

Genentech • Daly City, CA

5d • $233,500 - $433,600 • Onsite

About The Position

Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing late-development (Phase II–III) clinical strategies and plans that deliver medically differentiated therapies intended to meaningfully improve patients’ lives. The Lead Medical Director leads or makes major contributions to the development of Clinical Development (CD) strategy and plans, and is responsible for their effective and efficient execution for assigned molecules and indications.

The role supports development and implementation of the Clinical Development Plan (CDP), including gathering and analyzing the data and information needed to create the plan. It collaborates with internal and external partners and multidisciplinary groups such as business development, research, commercial, and legal. The Lead Medical Director may contribute clinical science input and guidance to early-development and Phase I discussions, including late-stage input on Phase I and II protocols.

The position contributes to regulatory filings and documentation with Clinical Strategy Team members and regulatory and other internal partners, providing clinical science information and input. It also ensures strategic and operational alignment of the CDP with the relevant CD strategy and strategic and annual LCP, and works with team members and sub-teams on CDP components such as analytics and data strategy, KOL development, and publications strategy. The position is based on-site in San Francisco, California, and relocation support is provided.

Requirements

• Board Certified/Board Eligible (or equivalent) MD (MBBS) or MD (MBBS)/PhD physician in Oncology and Hematology.
• At least 5 years of post-graduate relevant clinical/scientific research and/or clinical trial experience.
• At least 3 years of biopharmaceutical clinical development experience, including late-stage drug development.
• At least 3 years of medical monitoring experience in the life sciences space, with ability to support senior team members in this responsibility.
• At least 2 years of experience engaging with clinical sites, PIs, and KOLs.
• Solid understanding of Phase II–III drug development, through relevant development experience or formal education/qualifications in pharmaceutical medicine or drug development.
• Significant contributions to an organization’s drug development and experience identifying and creating clinical development strategies that have led to label-enabling outcomes.
• Ability to foster and promote a productive and inclusive team-based culture in fast-paced clinical and/or research settings.
• Significant experience with data analysis, interpretation, and clinical relevance, and demonstrated scientific writing experience, such as manuscripts, grants, scientific protocols, or health authority documents.
• Demonstrated communication skills in long-form scientific presentations and short-form communication of complex scientific topics.

Nice To Haves

• Disease-area focus in lymphoma.
• Strong interpersonal, verbal, and written communication and influencing skills, with a record of building and cultivating important internal and external relationships.
• Ability to collaborate with team members to measure and monitor study progress against objectives and plans, identify variances, and proactively communicate issues, challenges, and potential strategies to resolve them.
• Demonstrated experience with various clinical trial designs, including outcome trials.
• Sound knowledge of the pharmaceutical/biotechnology industry and the functions and roles involved in drug development.

Responsibilities

• Lead or make major contributions to development of Clinical Development strategy and plans for assigned molecules and indications.
• Ensure effective and efficient execution of the Clinical Development strategy and plans.
• Support development and implementation of the Clinical Development Plan, including gathering and analyzing necessary data and information.
• Collaborate with internal and external partners and multidisciplinary groups, including business development, research, commercial, and legal.
• Provide clinical science input and guidance in early-development and Phase I discussions, including late-stage input to Phase I and II protocols.
• Work with Clinical Strategy Team members, regulatory partners, and other stakeholders to complete and submit regulatory filings and documentation.
• Provide clinical science information and input for regulatory submissions and processes.
• Ensure strategic and operational alignment of the Clinical Development Plan with the relevant Clinical Development strategy and strategic and annual LCP.
• Work with team members and sub-teams to develop Clinical Development Plan components, including analytics and data strategy, KOL development, and publications strategy.

Benefits

• Relocation support.
• A discretionary annual bonus may be available based on individual and Company performance.
• Benefits are available as detailed at the linked benefits page.

What This Job Offers

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