Lead Medical Director, Product Development, Ophthalmology

Genentech • South San Francisco, CA

131d • $233,500 - $433,600

About The Position

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). 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 a variety of internal/external partners & stakeholders, as well as multidisciplinary internal groups, including business development, research, commercial, legal, etc. You may participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input & guidance; including reviewing and providing late stage input to Phase I & II protocols. You have a demonstrated understanding of Phase II - III drug development. You will 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. Provides clinical science information and input for regulatory submissions and other regulatory processes. Includes developing label and packaging language, etc. You will be responsible to ensure strategic and operational alignment of the CD plan with the relevant CD strategy, strategic and annual LCP; you will work with other CST members and relevant sub-teams to develop CD plan components (e.g., analytics/data strategy, KOL development, publications strategy, etc.) This position is based in South San Francisco, CA, (USA), Boston, MA (USA), Welwyn, UK or Basel, Switzerland. Relocation benefits are not being offered for this position.

Requirements

• MD/MBBS, MD/PhD.
• 3+ years clinical experience.
• Board Certified training in Ophthalmology.
• 4+ years of pharma/biotech late stage clinical development experience.
• Significant experience working with the principles and techniques of data analysis, interpretation and clinical relevance.

Nice To Haves

• Demonstrated late stage development experience in retina-related diseases.
• Experience as a clinical development lead.
• Proven ability to use sophisticated analytical thought and identify innovative approaches.
• Experience working with various clinical trial designs (e.g., accelerated approval, pivotal, breakthrough).
• Sound knowledge of the pharma/biotech industry and the drug development process.
• Strong interpersonal skills and ability to influence internal partners and stakeholders.

Responsibilities

• 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 & stakeholders, including business development, research, commercial, legal, etc.
• Participate in meetings, reviews, discussions regarding early development/Phase I studies.
• Provide clinical science input & guidance for Phase I & II protocols.
• Ensure strategic and operational alignment of the CD plan with the relevant CD strategy.
• Work with CST members and relevant sub-teams to develop CD plan components.
• Take an active role in the completion and submission of regulatory filings and documentation.

Benefits

• Discretionary annual bonus based on individual and Company performance.

What This Job Offers

• Job Type: Full-time
• Industry: Chemical Manufacturing
• Education Level: No Education Listed