We are looking for an immunogenicity expert to lead our efforts in the field, while partnering with the BioAnalytical Sciences (BAS) Leadership team. This individual will provide strategic direction and scientific leadership for end to end immunogenicity activities for biologics from late stage research through post marketing. This individual will develop close partnerships that result in a detailed understanding of the immunogenicity landscape at Genentech and be accountable for oversight and delivery of all immunogenicity activities.
Provide leadership and strategic guidance on the development and implementation of immunogenicity strategies for drug development programs including:
Act as primary interface, lead and coordinate immunogenicity efforts in partnership with internal (including Clinical Pharmacology, Safety Assessment, Protein Sciences, PTD, Clinical Safety, Clinical Scientists) and external partners for input and information exchange to understand the impact of immunogenicity in non-clinical and clinical settings
Engage with external stakeholders to influence best industry practices (ex. Immunogenicity risk mitigation)
Define the path to collect, leverage data and data analytics in advancing our understanding of immunogenicity for biologics. May leverage various methodologies, as well as collaborators, including and not limited to Systems Based Models and Advance Analytics
Drive immunogenicity excellence by identifying opportunities, mitigating risks and supporting continuous improvement
Provide and ensure expert immunogenicity input into relevant plans to support strategy execution and overall success across immunogenicity efforts at Genentech
Provide consultation for strategic decisions and responses to regulators for projects in non-clinical and all clinical phases of development
Coordinate immunogenicity risk ranking efforts for Development Sciences in close partnership with scientists in BAS, Safety Assessment, PTPK, Protein Sciences and PTD, to understand impact of immunogenicity in the clinical, clinical safety and product attributes of biologics
Drive innovation and work closely with internal and external groups (vendors, academic and regulatory) to ensure successful development and implementation of new strategies and technologies for immunogenicity characterization and risk ranking to advance our understanding in this space and that best practice is incorporated and shared.
Mentor professionals including PhD and BS/MS level scientists and research associates on immunogenicity, as well as on technologies/methodologies that may be used in exploratory and regulated areas.
Provide thought leadership and guidance on scientific and regulatory issues related to immunogenicity of biologics:
Maintain a thorough and current knowledge of the field landscape and literature
Influence and communicate current guidance on relevant scientific and regulatory issues; participate in development of policy internally and externally, as appropriate.
Review the appropriate content of regulatory documents (including INDs, Common Technical Documents, and labels). Participate in scientific review of in-licensing candidate molecules, as appropriate.
May be responsible for writing/reviewing reports for regulatory submissions (such as INDs or Common Technical Documents) as SME on immunogenicity.
Ph.D. in Immunology or related field required and at least 12 years of relevant post degree experience
Experience in setting strategy for understanding risk and mitigation of immune responses to biotherapeutic drugs
Extensive experience in immunogenicity testing for biologics (Omics, Multiparameter single cell analysis, de-immunization strategies)
Deep understanding of organizational and industry factors that influence the immunogenicity landscape
Knowledge of predictive algorithms and In vitro cell based risk assessment tools for biologics optimization and for minimizing immunogenicity risk
Excellent verbal and written communication skills with the proven ability to work effectively as a member of a multidisciplinary team
Strong communication & presentation skills, both written and verbal: exhibits professional maturity, confidence and competence. Knows how to summarize and communicate the key points and business case for others to effectively and expeditiously make important decisions
Ability to synthesize and prioritize complex issues and data, and identify and resolve critical issues
Proven track record of building strong and sustainable relationships with internal and external partners and stakeholders
Experience in influencing and negotiating across all levels of the organization
Demonstrated ability to apply conceptual thinking, analytical thinking & problem solving approaches to complex business challenges and decision making processes
Proven ability to handle ambiguity, work collaboratively with internal and external multidisciplinary teams
A strong publication record
Familiarity with System based models for immunogenicity
Expertise in CRO management for in vitro studies
Previous experience as a team leader
Leadership: is regarded as an expert in his/her field, is highly respected by others, can effectively contribute to longer-range drug development, and can lead cross-functional teams to successful results
Strategic agility: has in-depth knowledge and broad experience in the field, and is able to bring this to bear in accomplishing strategic goals and objectives
Understanding of regulations, processes and issues in drug development
Experienced in writing integrated summaries of immunogenicity
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.