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 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 the potential of B-cell directed therapies in autoimmune disease. There is a need for a seasoned drug developer to help develop and execute a strategy to maximize the benefit of our pipeline assets for patients with autoimmune disease.

The Principal 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 Principal Medical Director is also expected to contribute CD expertise to therapeutic area strategies and plans.

Principal 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. Principal Medical Directors may be assigned CD strategy development and implementation oversight for an entire therapeutic area. Although Principal Medical Directors typically do not have direct reports, Principal Medical Directors have successfully mentored other 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 within South San Francisco, CA; Boston, MA; Welwyn, UK or Basel, CH.

Relocation benefits will be offered for this position.

The review of applications will commence after January 5, 2025. Applicants selected for further consideration will be notified thereafter.

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.
• 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 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 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 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 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 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 can prioritize multiple tasks and goals on time, on target, and within budget.
• You are confident and competent 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 demonstrate 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
#PDC2025

Who we are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. For more information about equal employment opportunity, visit our Genentech Careers Homepage.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants. #J-18808-Ljbffr

---