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Clinical Operations Therapeutic Area Leader

1 month ago

Mississauga, Canada Genentech Full time

**The Position**:
At Roche/Genentech Pharma Product Development Global Clinical Operations (PDG), we are determined to transform drug development and realize our Pharma Ambition to deliver 20 transformative medicines addressing diseases with the highest societal burden by 2029. We are looking for a Clinical Operations Therapeutic Area Leader to lead and drive the delivery of our Immunology Portfolio. This senior people leadership position holds significant accountability for clinical operations strategy and execution as well as enterprise collaboration.

PD’s mission is to improve patients’ lives around the world through unique medicines that have a meaningful impact. Cross functionally we conduct global clinical trials, analyze results, monitor safety, and work with regulatory authorities to provide truly differentiated medicines to patients. Our primary therapeutic focus areas are Oncology, Hematology, Neurology, Immunology, Ophthalmology, Cardiovascular, Renal, and Metabolism. We attract, develop, and retain the most talented people in the industry, and have Development centers in Basel, Switzerland; South San Francisco, California; Welwyn Garden City, England; Mississauga, Canada; and Shanghai, China, as well as operations in many other countries.

**The Opportunity**:
The Immunology Clinical Operations Therapeutic Area Leader in PDG at Roche/Genentech is responsible and accountable for the strategy and delivery of the PD portfolio of programs and studies in Immunology. As the Immunology Therapeutic Area Leader, you will:
**Develop and Refine Immunology Portfolio Strategy**
Responsible for shaping and iterating the PD clinical operations strategy for Immunology. Align with the Clinical Development Plan (CDP) and the One Pharma Strategy to ensure optimal delivery of the Immunology portfolio.

**Portfolio Oversight and Risk Management**
Maintain active and collaborative oversight of Immunology assets and studies. Monitor portfolio status, anticipate risks, and implement proactive triaging and mitigation measures to ensure seamless operations.

**Strategic Stakeholder Alignment and Leadership**
Build and enhance cross-functional collaborations with PDG, APO, and COEs. Translate Late Stage Portfolio Committee OnePortfolio (LSPC) decisions into actionable PDG portfolio delivery strategies, balancing business needs and operational priorities.

**Drive Innovation and Operational Efficiency**
Leverage analytical tools and innovative processes to enhance clinical trial speed, quality, and patient
- and investigator-centric approaches. Focus on optimizing budget management, improving probability of technical success (PTS), and embracing new solutions to deliver strategic outcomes.

**Enterprise and External Engagement**
Represent PDG in Immunology-related discussions and decisions across Roche. Build relationships with internal leaders in early-stage R&D, PD Clinical Science, and Global Product Strategy, and engage external stakeholders like patient advocacy groups, Therapeutic Area Experts (TAEs), health authorities, and vendors.

**Leadership within the Portfolio Delivery Team**
Serve as a core member of the Portfolio Delivery Leadership Team, fostering collective leadership to align priorities across the PDG and PD organizations. Prioritize decisions that advance patient care and clinical trial efficiency.

**People Leadership and Team Development**
Lead a matrixed organization of approximately 150 employees, including 10-12 direct reports. Promote a culture of collaboration, inclusivity, and high performance, while emphasizing diversity, equity, and inclusion (DE&I). Inspire, develop, and manage talent to build a pipeline aligned with organizational goals.

**Engagement and Administrative Oversight**
Conduct regular performance assessments, provide coaching, and manage employment-related matters. Act as a role model for inclusive leadership, addressing barriers to growth, and fostering a high-engagement work environment.

**Who you are**:

- 15+ years pharmaceutical clinical Operations experience with at least 10 years being in global clinical operations Strategy Leadership. Additional commercial or relevant experience is considered an asset.
- Strong knowledge in the area of immune mediated disease, including external trends and issues in the global Immunology landscape and development
- Comprehensive understanding of global Pharma Clinical development in international settings
- Proven success in strategy development and execution using analytics, data-driven decision-making, and a track record of expanding access to underserved populations while meeting or exceeding ambitious goals.
- Experience managing large, matrixed organizations, including leading direct reports and people leaders, recruiting and developing high-performing teams, and fostering collaboration and trust with stakeholders.
- Fluency in English with additional language skills as an asset, and flexibility for frequent national or intern