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Sr. Clinical Program Leader, Clinical Operations

South San Francisco, California


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The Position

The Genentech Research and Early Development Sr Clinical Program Leader position is a key strategic leadership role accountable for evaluation of strategic options, development and delivery for assigned early development programs. The Sr. Clinical Program Leader helps define and implement vision and strategy for study management and is accountable for functional management including recruiting, building and maintaining a high quality Genentech Research and Early Clinical Operations.



Program Management Responsibilities

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

  • Recognized as expert thought partner in drug development with thorough understanding of all aspects of clinical drug development.

  • Core member and Clinical Operations representative on the Early Development Teams (i.e. Core, Development or Clinical Sub-Teams) serving as a primary consultant to senior-level colleagues, functional leadership and cross-functional stakeholders within and outside of Genentech Research and Early Development.

  • Makes broad contributions to the development of the clinical development plan, and establishes the operational strategy for new programs.

  • Partners with late stage to ensure strategic alignment of Clinical Development Plan, country/site strategies, and planning of end-to-end lifecycle of molecule.

  • Provides program leadership to global cross-functional teams across the Roche group including external partners and vendors through oversight, guidance, strategies and direction to achieve results.

  • Provides innovative and flexible operational solutions and ability to understand, critically assess and influence global clinical development plans, protocol design, resource needs, global budgets and timelines for programs.

  • Provides disease area expertise and input to the function while anticipating changes in the disease landscape (e.g. standards of care) and regulations that impact operational strategies.

  • Accountable for meeting all operational deliverables in accordance with time, cost and quality commitments. Maintains an overview of status, risks, and proactively communicates progress, issues or changes that may impact timelines and costs of the program to all stakeholders including the Therapeutic Area leadership. Maintains internal consistency across studies within a program.

  • Leverages internal resources pan-Roche to identify potential novel partnership opportunities to accelerate development of clinical programs while leveraging solutions, lessons learned and sharing knowledge broadly.

  • Participates in Business Development/in-licensing assessments as requested, providing strategic input as well as operational elements in terms of costs, resources, and timelines.

  • Leads Genentech Research and Early Development Clinical Operations Disease Teams and development of operational strategies across Genentech Research and Early Development molecules.

  • Provides disease area input as a member of global disease teams in partnership with Product Development, Pharma Research and Early Development, and Genentech Research and Early Development.



Functional Management Responsibilities

  • Provides leadership, guidance, and manage the performance and development of 5-6 direct reports; administer performance programs in accordance with policies, and ensure the development of potential succession candidates.

  • Identifies, recruits, and hires Clinical Operations Study Management staff, as well as oversees their work to ensure all department goals, deliverables and objectives are met.

  • Identifies and manages resource needs through proactive planning and effective recruitment.

  • Ensures that employees are appropriately trained, developed and coached to comply with company policies and Global regulations.

  • Participates in and/or leads working groups and/or business improvement efforts within the Genentech Research and Early Development organization to improve clinical trial processes, systems, methodologies, and tools.

  • Participates in enterprise wide initiatives (as needed) to support and influence the future direction of the organization.

  • Partners with Early Clinical Development Business Operations team to develop role-based competency and training strategies and programs.

  • Partners with Early Clinical Development Informatics team to establish strategies and priorities in support of improving and advancing clinical trials.

  • Advocates/drives/supports goals and changes within the organization.

  • Leads by example to create a positive work environment by encouraging mutual respect, innovation, smart risks and accountability on a functional and project level, both locally and globally, to help the organization to continuously evolve, improve and excel.



Qualifications

  • Bachelor's Degree or equivalent required (scientific or healthcare discipline preferred). Advanced degree preferred.

  • 12+ years experience of clinical and drug development (or equivalent), including 5+ years of clinical trial management experience.

  • 2+ years of clinical program management experience.

  • Working knowledge of international regulatory and ICH Good Clinical Practice guidelines.

  • Proven ability to lead teams, form productive working relationships within and external to the department, using the skills of collaboration and influence in areas of problem solving.

  • Demonstrated ability to work in a volatile, uncertain, complex and ambiguous environment and skilled at making quick and informed decisions with limited information.

  • Substantial experience in organization, implementation, and delivery of global clinical programs.

  • Demonstrated ability to manage larger-scale, cross-functional strategic projects, activities and teams; effectively formulate strategies, tactics and action plans to achieve results, and continuously move the business forward.

  • Uses understanding of major business functions, industry trends, and own organization's position to contribute to effective business strategies and/or tactics.

  • Meaningful analytical skills, including previous experience with forecasting, analyzing and interpreting benchmarking research results. Ability to analyze complex activities and information to arrive at reasonable conclusions.

  • Identifies and leverages opportunities to accelerate results and build capability by assigning tasks and decision-making responsibilities to individuals or teams with clear boundaries, expectations, support, and follow-up.

  • Demonstrated ability to think globally and apply creative solutions to problems without defaulting to status quo including welcoming diversity of thought to make decisions.

  • Change leader with ability to drive, encourage and support innovation.

  • Ability to think beyond own department, identifying connections between different areas of the organization to positively impact the business and its customers.

  • Ability to set clear vision/strategies and removes obstacles for teams that are barriers to doing productive/high impact work.

  • Demonstrated leadership, influencing, and motivational skills. Communicates with energy and passion, to engage and inspire others.

  • Proven ability to coach, develop, manage performance, and mentor personnel.

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

#ClinicalTrials #ProgramManagement #GCP #Biotech #SFBayArea

Who We Are

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.

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.

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Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.


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