Lead Medical Director, Clinical Development, Rheumatology

The Position

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 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 participate in the design, development and execution of clinical studies.

• You will act as a medical monitor for assigned studies

• 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 proven understanding of Phase II - III drug development.

• You will take an active role with other Clinical Science Team (CST) members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation; you will provide clinical science information and input for regulatory submissions and other regulatory processes. 

• You will be responsible to ensure strategic and operational alignment of the CD plan with the relevant CD strategy, Asset team priorities and goals; 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 is on-site position, preferably based in South San Francisco, CA (USA); other locations are: Boston, MA (USA); Basel, Switzerland and Welwyn, UK.

No relocation benefits will be provided for this position.

Who You Are:

(Required)

• You have an MD/MBBS, MD/PhD, 3+ years clinical experience; Board Certified training (or its equivalent) in the Rheumatology space and/or 10+ years of clinical training/research experience within the Rheumatology space

• You have 2+ years of post-grad relevant clinical/scientific research and/or clinical trial experience

• 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)

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

Preferred:

• You have experience working in the pharmaceutical or biotech industry

• You have 2+ years of pharma/biotech clinical development experience.

• You have demonstrated experience working with various clinical trial designs, (e.g. accelerated approval, pivotal, breakthrough etc)

• You have sound knowledge of the pharma/biotech/diagnostics industry, the multiple functions and roles involved in the drug development process.

• You have the 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 such

• You have strong interpersonal skills: Outstanding interpersonal, verbal, and written communication and influencing skills: has built and cultivated important relationships both inside an  organization and externally. Has proven abilities to influence internal partners and stakeholders, thought leaders, national advocacy  organizations, national standard-setting bodies, and other relevant external parties. Seamlessly collaborates with colleagues/other parts of the organization

This is on-site p