The Director is a highly motivated individual with a proven track record of scientific, leadership, collaboration work, and management experience who plays a key leadership role in BioAnalytical Sciences. The incumbent will report to the Head of BioAnalytical Sciences; s/he will provide scientific, technical and strategic leadership and oversight of the Assay Development and Technology (ADT) deliverables focusing on Cancer ImmunoOncology portfolio encompassing all large molecules, spanning late stage research through post-marketing phases to enable advancement of candidate molecules. Planning horizon is of 15+ months.
Responsible for setting the strategic and technical direction for their function, and personnel (approximately 20 individuals)
Develops and manages related fiscal budgets, staffing, and planning processes
Responsible for bioanalytical strategies (PK, Immunogencity, soluble biomarkers), methods, data and documents for all ImmunoOncology biologics.
Ensure delivery of high quality bioanalytical data and regulatory documents (IND, BLA, global filings) and health authority interactions and scientific contributions to enable rational decision-making. Ensure regulatory compliance and scientific oversight.
Ensure new bioanalytical technologies are being assessed and incorporated when appropriate.
Provide guidance and direction to Scientists and RAs on data analyses, strategic issues related to projects, leadership and on sub-teams, etc.
Provide mentoring and career development of staff, and other employees as requested
Collaborate effectively with various stakeholders through out the company including global partners
Leads Development Sciences project teams, and cross functional initiatives as needed
Participates in scientific leadership and direction for Development Sciences
Presents data, collaborative findings, and plans to other GNE groups GNE management, partners and collaborators, as well as at conferences and regulatory meetings as appropriate
Strategic scientific and operational engagement with staff, BioAnalytical Sciences peer functional groups, Head of BAS and key stakeholders in Research, Development Sciences, Early Clinical Development, Product Development and others for the advancement of molecular entities through their drug development cycle
A Ph.D. in Immunology, Molecular Biology, Cell Biology or equivalent curriculum. Persons without formal degree who have comparable depth and breadth of training and experience and who meet job-specific criteria are eligible for consideration.
Typically 12+ years of relevant experience (drug development including post doctoral work for scientific roles or in impacting business and operational processes for business support roles) and at 5+ years of management experience. Prior management experience at the Director level or equivalent
Record of impactful performance and documented accomplishments, both in advancing drug development and business/operational processes
A strong background in immunology, cancer biology and/or cellular or molecular biology is also required along with a good understanding of the drug development process.
A strong track record of scientific accomplishment and credibility, and experience in bioanalysis/therapeutic immunogenicity is desired
The individual must have excellent inter-personal and communication skills, and the ability to lead and work with others in a positive and collaborative manner to set and meet organizational goals
Skills demonstrating initiative and creativity are also essential.
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.
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At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.