Principal Medical Director, Product Development, Rheumatology

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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 leadmultiple 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 development plan and have worked with various health authorities.

• You have a demonstrated level of knowledge of Phase II - III drug development (e.g trials across different stages of development); you have made significant contributions to an organization's drug development (whether at Roche or another organization); You have extensive experience designing and conducting clinical trials (i.e. multiple trials) across multiple disease indications; you have a comprehensive understanding of product and safety profiles.

• You have experience publishing results of a clinical trial in a peer-reviewed journal; you are internally recognized as a disease area scientific/development thought leader

• You have a strong level of knowledge of the pharma/biotech industry, the multiple functions and roles involved in the drug development process; you have extensive understanding of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA, and other relevant guidelines and regulations.

• You have outstanding written communication skills.

• You have outstanding business presentation skills. You can present a compelling business case and facilitate effective and expeditious decision-making. You have a proven ability to serve as a spokesperson both intenally and externally.

• You have an aptitude or proven ability to mentor colleagues and foster their successful career development; you have a strong orientation to teamwork.

• You are able to travel up to 30% globally.

Preferred:

• You have demonstated interpersonal, verbal, and written communication and influencing skills: have built and cultivated important relationships both inside the organization and externally; have proven abilities to influence internal partners and stakeholders, external thought leaders,and other relevant external parties; you are able to effectively manage pressure and conflict and you practice inclusive leadership; you have strong negotiation skills and can effectively drive discussions and decisions toward desired end-results.

• You have demonstrated experience working with various health authorities/regulator agencies.

• You can prioritize multiple tasks and goals on time, on target, and within budget.

• You have demonstrated competence when interacting with others at all levels, both internally and externally. You have demonstrated courage and conviction in past positions and responsibilities. You have demonstrated leadership through authenticity, transparency, self-awareness, and empathy consistent with Roche's Operating Principles.

• You have impeccable ethics and are able to align to Roche values.

The expected salary range for this position based on the primary location of South San Francisco, CA is $277,500 - $516,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

This position also qualifies for the benefits detailed at the link provided below.

Benefits

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