Senior Medical Director, Product Development, Rheumatology

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The Opportunity

Roche's Product Development organization is structured by therapeutic area and is responsible for developing and executing the late development clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. In the Nephrology/Rheumatology area, Roche is committed to exploring therapies for autoimmune diseases with high unmet need, including maximizing our pipeline assets targeting B-cells.

The Senior Medical Director leads development of the Clinical Development (CD) strategy and is responsible for developing the CD plan and ensuring effective and efficient execution for assigned molecule(s)/indication(s). The Senior Medical Director is also expected to contribute CD expertise to therapeutic area strategies and plans.

Senior Medical Directors are expected to act as CD leaders, demonstrate heightened mastery of the core Medical Director role, perform their responsibilities independently, and effectively lead multiple projects. Senior Medical Directors may be assigned CD strategy development and implementation oversight for an entire therapeutic area.

• 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, or Boston, MA.

Relocation benefits are not being offered for this position.

Who You Are:

(Required)

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

• You have 5+ years of pharma/biotech R&D experience, with the majority focused on rheumatology drug development; 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 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 demonstrated experience as a cross functional project team lead

• 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 demonstrated experience authoring a global clinical development plan and have worked with various health authorities.

• You are able to travel up to 30% globally

Preferred:

• 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 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 outstanding 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 have extensive understanding of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA, and other relevant guidelines and regulations.

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

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

• 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 ability to mentor colleagues and foster their successful career development

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

The expected salary range for this position based on the primary location of South San Francisco, CA is $253,500 - $471,000. 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

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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