Principal Medical Director, Product Development, Rheumatology

The Position

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

The Opportunity

Roche’s Product Development (Late Stage, Clinical Development) organization is organized by therapeutic area and plays a critical role in shaping and executing clinical strategies that bring medically differentiated therapies to patients. This is an exciting period of growth and innovation at Roche. Within the Immunology Therapeutic Area, we are dedicated to advancing B-cell directed therapies for autoimmune diseases. As part of our expanding efforts, we’re thrilled to introduce a newly created Principal Medical Director position to support our growing Rheumatology pipeline.

The Principal Medical Director will help develop and excute a strategy to maximize the benefit of our pipeline assets for patients with autoimmune disease. This person will lead development of the Clinical Development (CD) strategy and is responsible for ensuring effective and efficient execution for assigned  molecule(s)/indication(s). A Principal Medical Director is expected to act as a clinical development leader, perform their responsibilities independently, and effectively lead multiple projects. Principal Medical Directors may be assigned CD strategy development and implementation oversight for an entire therapeutic area. Principal Medical Directors are expected to sucessfully mentor other medical directors and/or scientists in their disease area of expertise.  

• You will lead, delegate and be responsible for the development and implementation of the CD strategy and/or plan for assigned molecule(s)/indication(s); you will represent CD for the assigned molecule(s)/indication(s) to other internal Roche groups; you will be responsible for ensuring cross-functional integration, coordination and alignment to enable effective and efficient CD plan execution .

• You have demonstrated late stage clinical development expertise with relevant experience in Rheumatology, ideally with specific experience in late phase studies in systemic lupus erythematosus and/or lupus nephritis.

• You have demonstrated experience as a cross functional project team lead

• You will collaborate with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians,  scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups in PD, research, business development, commercial operations, legal, etc. 

• You will participate in meetings, reviews, discussions and other interactions regarding early development studies to  provide clinical science input and guidance; includes reviewing and providing late stage input into Phase I and II protocols

• You will lead or oversee others in development of briefing packages, development of responses to health authority questions, and health authority interactions by providing clinical science information and input. 

• You will consult to pharma partnering on relevant acquisitions, joint ventures or other strategic partnerships, as these potentially relate to the assigned therapeutic/disease area(s).
   

This position is based on-site in South San Francisco, CA; Boston, MA; Welwyn, UK or Basel, CH.

Relocation benefits will be offered for this position.

Who You Are:

(Required)

• You have an MD/MBBS with relevant clinical, scientific and development experience in rheumatology, specifically late stage experience in systemic lupus erythematosus and/or lupus nephritis. Board-certification/Board eligibility in rheumatology is preferred.

• You have extensive experience working with the principles and techniques of data analysis, interpretation, and clinical relevance. You are able to evaluate, interpret and present highly complex data across multiple studies (prospective and retrospective). 

• You have 8+ years of pharma/biotech R&D experience; with demonstrated experience in late stage clinical development.

• You have a proven track record of effective decision making skills; making good business decisions/exercising sound business judgment; consistently and effectively balances decisions with imperatives for ethics and efficacy; you are able to make trade-off decisions and determine priorities and goals

• You have demonstrated experience as a cross functional project team lead; you have demonstrated experience authoring a global clinical develo