Medical Director, Product (Late Stage) Development, Immunology

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

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 Medical Director leads or 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 (preferred); Basel, CH; or Welwyn, UK.

Relocation benefits are not being offered for this position.
 

Who You Are:
(Required)

• You are a Board Certified/Board Eligible (or its equivalent) MD (MBBS), MD(MBBS)/PhD  physician

• You have substantial research and clinical experience

• You have demonstrated the ability to foster and promote a highly productive and inclusive team-based culture in fast-paced clinical and/or research settings

• You have 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)

• Outstanding communication skills in both long-form scientific presentation and short-form communication of complex scientific topics

• Strong interpersonal skills: Outstanding interpersonal, verbal, and written communication and influencing skills: has built and cultivated 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
   

Preferred:

• You are a trained rheumatologist and/or have training in a related field

• 2+ years of experience in biopharmaceutical clinical development

• If you do not have biopharmaceutical clinical development experience, the following academic research experience may be especially important:

  • Scientific Thought Leadership: A distinguished record of lead authorship (first or senior author) 

  • Demonstrated Funding Success: Success in securing competitive external research funding, including NIH grants (e.g., K-series, R01) or equivalent prestigious international funding bodies (e.g., MRC, ERC, CIHR)
     

• You have the proven ability to use sophisticated analytical thought and to identify and implement innovative approaches.

• You have demonstrated experience working with clinical trials

• You have sound knowledge of the pharma/biotech industry, the multiple functions and roles involved in the