South San Francisco, California
We are looking for a highly motivated and talented individual to lead our CRO strategy and operations efforts within the Drug Metabolism and Pharmacokinetics (DMPK) department. DMPK supports projects from early stage research to NDA and beyond. DMPK uses outsourcing as a key strategic lever to provide high quality support for all of our portfolio projects. DMPK supported activities are outsourced to highly collaborative full time employee based teams as well as through numerous fee-for-service contracts. This position requires excellent strategic thinking and project management skills to ensure operational excellence and awareness/planning of future outsourcing opportunities that enhance our capabilities while managing operational risks. This individual work closely with scientific, technical and operational experts in DMPK and with other departments such as Research Contracts and Procurement who will provide additional logistical support. Finally, the candidate will work closely with the Associate Director of Small Molecule Outsourcing and other outsourcing managers within Small Molecule Drug Discovery (SMDD) to support our extensive worldwide CRO partnerships.
Serve as the key manager and coordinator of all DMPK outsourcing activities, in particular for our large FTE and FFS arrangements.
Establish long-range strategic outsourcing plan that complements our in house capabilities, addresses operational risks and capitalizes on external opportunities.
Provide strategic and operational guidance ensuring CROs’ capability, capacity, and lead-time meet Genentech requirements. In collaboration with the DMPK leadership team and technical experts, ensure appropriate staffing levels for outsourced activities.
Be the liaison for all of DMPK when interfacing with CROs.
Facilitate regular communications, virtual and face-to-face, between DMPK and CROs and serve as the interface between the technical experts and CROs.
In collaboration with technical experts in DMPK, help establish key performance indicators (KPIs); as well as, track, identify, track and communicate operational gaps.
In collaboration with technical experts in DMPK, regularly review risks and mitigation strategies associated with our outsourced activities.
Assist technical experts with identification of new outsourcing opportunities and externalization of assays to CROs.
Work closely with the SMDD outsourcing group to proactively develop outsourcing strategies that coordinate activities across SMDD to ensure operational efficiency and rapid progression of compounds through testing cascades.
Interact with senior leaders in SMDD and elsewhere on CRO management.
Keep abreast of technical developments in the field and influence CROs to build relevant capabilities. Monitor industry trends.
May supervise direct reports.
B.S. or PhD/MBA in business management and/or STEM with a minimum of 7 years of experience in managing outsourcing activities in drug discovery and development, e.g. outsourcing, procurement, or CRO business development.
In depth knowledge of DMPK, drug discovery and development, management experience and project management accreditation (PMP) are highly desirable.
In depth knowledge / use of Smartsheet, Trello, Workfront, MS Project or other project / task management software is highly desirable.
Demonstrated ability to establish long-range strategic plans that capitalize on internal needs and external capabilities while managing operational risks.
Demonstrated ability to establish and track KPIs to ensure operational excellence.
Outstanding interpersonal skills to establish and maintain close and effective working relationships with internal stakeholders in DMPK and SMDD, CROs, and cross-functional and cross-cultural teams.
Evidence of strong negotiation skills with the ability to identify and implement desirable solutions to strategic and operational challenges as well as manage conflict.
Proven ability to lead people, groups, and teams.
Excellent oral/written communication and organizational skills.
Excellent judgment and demonstrated analytical ability and problem-solving skills.
Attention to detail, accuracy, and timelines.
Available for travel both domestic and international.
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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