Lead Medical Director, Product Development, Hematology

Roche • South San Francisco, CA

5d • $233,500 - $433,600 • Onsite

About The Position

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

The role supports development and implementation of the Clinical Development Plan (CDP), including gathering and analyzing information needed to create the plan. It collaborates with internal and external partners and multidisciplinary groups, including business development, research, commercial, and legal teams. The Lead Medical Director may provide clinical science input on early development and Phase I studies, including late-stage input on Phase I and II protocols. The role also contributes clinical science information to regulatory submissions and processes, and works with Clinical Strategy Team members, regulatory partners, and other stakeholders on filings and documentation.

The position ensures strategic and operational alignment of the CDP with the relevant Clinical Development strategy and strategic and annual LCP. In collaboration with team members and sub-teams, the Lead Medical Director develops CDP components such as analytics and data strategy, key opinion leader 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 relevant postgraduate clinical or 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.
• At least 2 years of experience engaging with clinical sites, principal investigators, and key opinion leaders.
• Solid understanding of Phase II–III drug development, gained through experience across development stages or formal education or qualifications in pharmaceutical medicine or drug development.
• Significant contributions to an organization’s drug development and experience creating clinical development strategies that have led to label-enabling outcomes.
• Demonstrated ability to foster a productive and inclusive team-based culture in fast-paced clinical 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.
• Outstanding 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, communicate variances and issues proactively, and develop potential resolution strategies.
• Demonstrated experience with various clinical trial designs, including outcome trials.
• Sound knowledge of the pharmaceutical and biotechnology industry and the functions and roles involved in drug development.

Responsibilities

• Support development and implementation of the Clinical Development Plan for assigned molecules or indications, gathering and analyzing information needed to create the plan.
• Collaborate with internal and external partners and multidisciplinary groups, including business development, research, commercial, and legal teams.
• Provide clinical science input and guidance on early development and Phase I studies, including late-stage input on Phase I and II protocols.
• Contribute clinical science information and input to regulatory submissions and processes, and work with Clinical Strategy Team members, regulatory partners, and other stakeholders on filings and regulatory documentation.
• Ensure strategic and operational alignment of the Clinical Development Plan with the relevant Clinical Development strategy and strategic and annual LCP.
• Work with Clinical Strategy Team members and relevant sub-teams to develop Clinical Development Plan components, including analytics and data strategy, key opinion leader development, and publications strategy.
• Support senior team members with medical monitoring responsibilities.
• Collaborate with relevant team members to measure and monitor study progress against objectives and plans, communicate variances and issues, and identify potential resolution strategies.

Benefits

• Relocation support is provided.
• A discretionary annual bonus may be available based on individual and Company performance.
• The position qualifies for benefits detailed at the linked benefits page.

What This Job Offers

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