Lead Medical Director

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We advance science so that we all have more time with the people we love.

With recent exciting developments in the haematology therapy area, we are now looking for a motivated physician with drug development experience in haematology/oncology. This role is an opportunity to contribute and develop haematology treatments in the non-malignant haematology space, specifically within haemophilia and gene therapy.

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

The Opportunity

You will 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.

You will collaborate with internal/external partners & stakeholders, including multidisciplinary internal groups such as research, commercial, legal, and business development. You will act as a subject matter expert on trial-related issues, health authority interactions, and liaison with key opinion leaders, providing publications support.

You will participate in meetings, reviews, and discussions regarding early development/Phase I studies to provide clinical science input and guidance, including reviewing and providing late-stage input to Phase I & II protocols. There is a seamless collaboration model within the franchise, with close liaison between early and late-stage functions.

You have demonstrated experience in Phase II - III drug development.

You will work with regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and documents, providing clinical science information and input for regulatory submissions, including developing label and packaging language.

You will ensure strategic and operational alignment of the CD plan with the relevant strategies and work with other team members to develop components such as analytics/data strategy, KOL development, and publications strategy.

This position is based in South San Francisco, CA, Welwyn, UK, and/or Basel, CH. Relocation benefits are not being offered for this position.

Who You Are:

(Required)

• You have an MD/MBBS, MD/PhD, with 3+ years of clinical experience; Board Certified in Hematology/Oncology.
• You have significant experience in data analysis, interpretation, and clinical relevance.
• You have 5+ years of pharma/biotech late-stage clinical development experience.

Preferred:

• Experience in non-malignant hematology, such as hemostasis and thrombosis, and knowledge of hemophilia/gene therapy landscape.
• A PhD with research experience and publications in scientific journals is preferred.
• Proven experience as a clinical development lead, with the ability to use analytical thinking, identify innovative approaches, and mentor others.
• Experience with various clinical trial designs, including accelerated approval, pivotal, and breakthrough trials.
• Knowledge of the pharma/biotech industry and drug development process.
• Ability to collaborate, monitor study progress, and communicate proactively about issues and strategies.
• Strong interpersonal, verbal, and written communication skills, with the ability to influence and build relationships inside and outside the organization.

Relocation benefits are not being offered for this position.

The salary range for this position is 233,500-433,600, depending on location, experience, and qualifications. A discretionary bonus may be available.

This position qualifies for company benefits as detailed in the provided link.

Genentech is an equal opportunity employer, committed to fair employment practices and nondiscrimination.

If you require accommodations for the application process due to a disability, please contact us via the provided form.