Lead Medical Director, Product Development, Hematology

About the role

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 providing meaningful improvement to patients.

The Lead Medical Director leads or makes major contributions to the development of the Clinical Development (CD) strategy and plan and is responsible for effective and efficient execution for the assigned molecule(s)/indication(s).

• Support the development and implementation of the Clinical Development Plan (CDP) for assigned molecule(s)/indication(s), gathering and analyzing data and information necessary to create the CD plan.
• Collaborate with a variety of internal and external partners and stakeholders, as well as multidisciplinary internal groups, including business development, research, commercial, and legal.
• Participate in meetings, reviews, discussions, and other interactions regarding early development/Phase I studies to provide clinical science input and guidance, including reviewing and providing late-stage input to Phase I and II protocols.
• Take an active 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 processes.
• Ensure strategic and operational alignment of the CDP with the relevant CD strategy, strategic, and annual LCP; work with other CST members and relevant sub-teams to develop CDP components (e.g., analytics/data strategy, KOL development, publications strategy).

This position is based on-site in Boston, MA (US), San Francisco, CA (US), Basel, CH, or Welwyn, UK. Relocation support will not be provided.

Requirements

• Board Certified/Board Eligible (or its equivalent) MD (MBBS), MD(MBBS)/PhD physician in Oncology & Hematology.
• 5+ years of post-graduate relevant clinical/scientific research and/or clinical trial experience.
• 3+ years of experience in biopharmaceutical clinical development with a focus on late-stage drug development.
• 3+ years of medical monitoring experience within the life sciences space; ability to support senior team members in this responsibility.
• 2+ years of experience engaging with clinical sites, PIs, KOLs, etc.
• Solid 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).
• Significant contributions to an organization’s drug development, including identifying and creating clinical development strategies that have led to label-enabling outcomes.
• Demonstrated ability to foster and promote a highly productive and inclusive team-based culture in fast-paced clinical and/or research settings.
• 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).
• Demonstrated communication skills in both long-form scientific presentation and short-form communication of complex scientific topics.

Preferred Qualifications

• Disease area of focus in Lymphoma.
• Strong interpersonal skills: outstanding verbal, written communication, and influencing skills; ability to build and cultivate important relationships both inside and outside an organization.
• Ability to collaborate with relevant team members to measure and monitor study progress against objectives and plans, including any variances, and proactively communicate issues, challenges, and potential strategies to resolve them.
• Demonstrated experience working with various clinical trial designs, including outcome trials.
• Sound knowledge of the pharma/biotech industry, including the multiple functions and roles involved in the drug development process.

Pay

The expected salary range for this position based on the primary location of Boston, MA is $213,000 - $396,000. 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.

Benefits

This position qualifies for the benefits detailed at the provided link.