/ Hiring

Sr. Clinical Program Leader-gRED

Who We Are

At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.

The Position

 Purpose: 

The Genentech Research and Early Development (gRED) Clinical Program Leader (CPL) position is accountable for operational strategy for assigned early development programs. The CPL is accountable for functional management including recruiting, building and maintaining a high quality gRED Clinical Operations organization. 

Primary Accountabilities and Responsibilities: 

Program Management Responsibilities: 

Through appropriate leadership, direction and operational expertise, lead the development and execution of operational strategies for multiple molecules/programs in Genentech’s early development portfolio: 

• Represent Clinical Operations on the Early Development Teams (i.e. Core, Development or Clinical Sub-Teams) 

• Develop program timelines and budgets and manage variance 

• Provide strategic, operational input to clinical development plan (CDP), target product profiles (TPP) and project plans 

• Lead the Clinical Operations team to ensure effective development, implementation and execution of all clinical trials within agreed timelines, resources and budget 

• Develop and present operational plan to management review bodies 

• Identify program risks and develop and implement mitigation strategies for assigned programs 

• Define the resourcing and outsourcing strategy for early development programs 

• May participate in Business Development assessments 

• Work collaboratively, effectively, and efficiently with all internal and external partners and stakeholders 

• Partner with Business Management to identify strategic business needs to support the clinical programs 

• Partner with late-stage development leaders to ensure strategic alignment on the CDP 

Functional Management Responsibilities: 

Identify, recruit, hire, and develop Clinical Operations staff, as well as oversee their work to ensure all department goals, deliverables, and objectives are met. Additionally, contribute to the Clinical Operations organization. These responsibilities include: 

• Manage Clinical Operations staff including development, coaching, mentoring, performance management, and succession planning 

• Ensure that employees are appropriately trained and comply with company and regulatory standards 

• Create a positive work environment by encouraging mutual respect, innovation and accountability 

• Resource projects to enable teams to meet deliverables 

• Create and maintain Clinical Operations as a ‘great place to work’ 

• Participate in and/or lead working groups and/or initiatives within the gRED organization or cross functionally as required 

• Partner with Process and Training Management (PTM) to optimize and continually improve processes; to create and maintain role definitions and standards; and to develop role-based competency and training programs 

• Create an environment supporting innovation and smart risk to help the department continuously evolve, improve and excel *LI-EK1

Who You Are

Requirements: 

Minimum: 

• 10+ years experience of clinical and drug development, including 5+ years of clinical trial management experience 

• 2+ years of clinical program management experience 

• Functional management experience 

• Experience in early phase clinical development 

• Bachelors Degree or equivalent required (scientific or healthcare discipline preferred). Advanced degree preferred 

• Working knowledge of international regulatory and ICH GCP guidelines 

Experience, Skills, Knowledge: 

• Demonstrated understanding, knowledge, and experience of drug development in a complex setting with particular focus on early development 

• Demonstrated experience in various therapeutic areas 

• Strong analytical and strategic agility skills 

• Excellent planning and organizational skills 

• High level of initiative and ability to work independently 

• Exceptional leadership skills, including motivation and delegation 

• Highly effective team player and exceptional interpersonal skills 

• Strong financial acumen with experience managing clinical program budgets 

• Proven ability to provide functional management including performance management coaching and staff development 

• Proven ability to implement and manage a clinical program (i.e. a series of studies compromising a clinical development plan) 

• Ability to drive, encourage and support innovation 

• Demonstrated ability to challenge established practices and concepts 

• Highly effective verbal and written communication skills in English 

Other (e.g. Travel): 

Willingness to travel domestically and internationally, and work across cultures. 

The next step is yours. To apply today, click on the "Apply online" button below.

Genentech is an Equal Opportunity Employer.