Lead Medical Director, Product Development, Hematology

Roche

1d • $213,000 - $396,000 • Onsite

About The Position

The Lead Medical Director plays a crucial role within Roche’s Clinical Development organization, which is structured by therapeutic area. This role is responsible for developing and executing late-stage (Phase II-III) clinical strategies and plans to deliver medically differentiated therapies that offer significant patient benefits. The Lead Medical Director will lead or significantly contribute to the Clinical Development (CD) strategy and plan, ensuring its effective and efficient execution for assigned molecules or indications. This involves supporting the development and implementation of the Clinical Development Plan (CDP), gathering and analyzing necessary data, and collaborating with a wide range of internal and external partners, including business development, research, commercial, and legal teams. The position may also involve providing clinical science input and guidance for early development/Phase I studies, including reviewing and providing late-stage input to Phase I & II protocols. A key responsibility is to ensure strategic and operational alignment of the CDP with the relevant CD strategy and LCP, working with team members to develop CDP components such as analytics/data strategy, KOL development, and publications strategy. The role also involves active participation with other Clinical Science Team (CST) members, regulatory affairs, and other internal partners in the completion and submission of regulatory filings and documentation, providing essential clinical science information and input.

Requirements

• Board Certified/Board Eligible (or its equivalent) MD (MBBS), MD(MBBS)/PhD physician in Oncology & Hematology.
• 5+ years of post-grad relevant clinical/scientific research and/or clinical trial experience.
• 3 or more years of experience in biopharmaceutical clinical development with experience in late-stage drug development.
• 3+ years of medical monitoring experience within the life sciences space.
• Ability to support senior team members with medical monitoring responsibilities.
• 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).
• Demonstrated significant contributions to an organization’s drug development (whether at Roche or another organization).
• Experience 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.
• 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.

Nice To Haves

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

Responsibilities

• Lead or make major contributions to the development of the Clinical Development (CD) strategy and plan.
• Ensure effective and efficient execution of the CD strategy and plan for assigned molecule(s)/indication(s).
• Support the development and implementation of the Clinical Development Plan (CDP) for assigned molecule(s)/indication(s).
• Gather and analyze data and information necessary to create the CD plan.
• Collaborate with internal/external partners and stakeholders, including business development, research, commercial, and legal.
• Provide clinical science input and guidance for early development/Phase I studies, including reviewing and providing late-stage input to Phase I & II protocols.
• Take an active role with CST members, regulatory, and other internal partners/stakeholders in the completion and submission of regulatory filings and documentation.
• Provide clinical science information and input for regulatory submissions and other regulatory processes.
• Ensure strategic and operational alignment of the CDP with the relevant CD strategy, strategic and annual LCP.
• Work with CST members and relevant sub-teams to develop CDP components (e.g., analytics/data strategy, KOL development, publications strategy).

Benefits

• Discretionary annual bonus may be available based on individual and Company performance.
• Benefits detailed at the link provided below.
• Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence.
• The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
• Accommodations for Applicants: If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form.

What This Job Offers

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