VP, Head of BioAnalytical Sciences

The Head of BioAnalytical Sciences (BAS) is accountable for the strategic, scientific and organizational leadership of a bioanalytical organization with local and global responsibilities for the gRED, Roche Product Development and Post-Marketing portfolios.

The organization is comprised of four main departments including the Bioassay team, Immunoassay team, MassSpec team and the Regulated Bioanalysis Implementation & Oversight team delivering foundational bioanalytical data (PK, ADA and soluble biomarker) across all phases of drug development. In this role, the leader has global responsibilities with significant influence on gRED's drug development projects and decisions, and direct impact on development and approval of pharmaceuticals in the US and Rest of World (RoW).

The leader has a strong commitment to implementing an agile operational model leveraging efficiencies and synergies within the organization, across gRED and the wider Roche network to deliver high quality bioanalytical methods and data in compliance with global regulatory and industry standards with a lean organizational footprint and efficient use of our resources. The Head of BAS will foster an innovative scientific environment with special emphasis on excellence in execution and delivery of the portfolio.

This role works closely and collaborates with leaders across Research, Drug Discovery, Early Clinical Development, Translational Medicine and Development Sciences (DevSci) in gRED as well as other parts of the Genentech and Roche organization, including but not limited to Roche Product Development and pRED Pharmaceutical Sciences, to contribute to strategies to develop impactful therapies that provide transformative benefit for patients.

The Head of BAS will report directly to the Senior Vice President DevSci, and will be a member of the DevSci Leadership Team (DSLT). Additionally, this role contributes as a member of the Research Review Committee (RRC) and the Development Boards (DB), and an ad hoc member of gRED's Early-Stage Portfolio Committee (ESPC).

Functional Role and Key Accountabilities

The gRED portfolio spans multiple therapeutic areas -oncology, neuroscience, infectious diseases, ophthalmology, metabolism and immunology. It consists of a diverse spectrum of therapeutic modalities, including but not limited to synthetic pharmaceuticals, biotherapeutics, nucleic acid-based medicines and gene and cell therapy products.

BioAnalytical Sciences is a key component of gRED's drug development organization essential for delivery of gRED's innovative portfolio. The department provides bioanalytical and immunogenicity assessment strategies, assays and expertise for all protein/ peptide-based therapeutics and advanced modalities, including cell therapies or nucleic acid-based medicines across all phases of drug development through approval and post-marketing life cycle activities.

The Head of BAS is accountable for the development, qualification and validation of innovative bioanalytical methods on a diverse array of technical platforms using internal laboratories, the deployment/ outsourcing of these methods to external Contract Research Organizations (CRO), and the generation of regulated bioanalytical data for nonclinical and clinical studies through global CROs in compliance with international regulatory standards.

The leader oversees and manages gRED's global bioanalytical CRO portfolio including PK, ADA and soluble biomarker sample operations, and provides quality and technical oversight over the bioanalytical sample testing and results reporting. This position is also responsible for providing well-characterized assay reagents, that meet global regulatory and industry standards in support of our global portfolio.

The Head of BAS will lead the bioanalytical organization across multiple organizational levels based in South San Francisco and will also oversee bioanalytical work for clinical trials executed in China with a small team of China-based employees.

Key Accountabilities as Head of BioAnalytical Sciences

• Responsible for organizational leadership of a high performing and well-aligned bioanalytical organization including but not limited to overall budget planning/ execution, staffing, regulatory compliance, scientific oversight and organizational change management;

• Accountable for setting the strategic direction of the BAS organization to meet the business needs in support of a dynamic and complex portfolio;

• Scientific and organizational oversight of bioanalytical assay, immunogenicity, and in vitro and in vivo characterization strategies;

• Responsible for assay development of pharmacokinetic, immunogenicity and biomarker methods from DevGo through all clinical development phases into post-marketing;

• Responsible for procurement and/or generation of well-characterized critical assay reagents for use through the drug development lifecycle by BAS and other groups in gRED, e.g. Translational Medicine;

• Oversight over the generation of foundational bioanalytical data (internally or through CRO) for nonclinical and clinical pharmacokinetic analyses, characterization of immune responses, and target engagement by characterization of biomarkers.

• Accountability for immunogenicity data interpretation and conclusions required for global regulatory filings and drug labeling;

• Responsible for identification of global contract laboratories to meet the global portfolio needs, accountability for management of a portfolio of contract laboratories spanning more than 500 methods and more than 200 non-clinical and clinical studies, and oversight of method transfer, sample testing, technical oversight and data transfers while ensuring high quality, regulatory compliance and timeliness for meeting project requirements;

• Accountability for management of PK/ ADA global biosample operations and coordination of bioanalytical sample testing and results reporting with vendor and internal labs for non-clinical and clinical studies, enabling both the gRED bio-therapeutics and small molecule global portfolio through all phases of clinical development and post-marketing;

• Accountability for setting strategic direction on key business decisions like investigation and implementation of novel technologies to meet bioanalytical challenges of an increasingly complex modality portfolio, evolution a global outsourcing strategy in compliance with US and RoW regulatory requirements to ensure the global portfolio needs are met;

• Building and maintaining close collaborations with gRED and global PD, pRED and DIA functions to deliver the pipeline;

• Support regulatory filings ensuring high quality delivery of key data for global regulatory documents such as INDs/CTAs and NDAs/BLAs, and due diligence and asset integration activities as needed;

• Ensure BAS delivers its objectives on time within budgets to the required standards and within a clear resource allocation and prioritization framework;

• Influence appropriate governance bodies to establish strategic directions across the entire organization to ensure scientific quality, improve efficiency and accelerate the product pipeline forward;

• Drive collaborations across Genentech and Roche to partner on high priority shared goals and initiatives;

• Seek, encourage and maintain external involvements and collaborations to ensure visibility and impact of BAS and its staff in the external scientific and regulatory community;

• Ensure succession, recruitment, mentorship, and career development plans are in place to develop, hire and retain the best scientific talent and future leaders and ensure appropriate training and adherence to regulations and business compliance requirements of all staff;

• Set appropriate personal goals, evaluate team member performance, and provide timely performance appraisal and feedback;

Qualification and Experience

• Doctor of Philosophy (PhD) or equivalent curriculum in a relevant discipline is required. Individuals without a formal degree who have comparable depth and breadth of training and experience and who meet job-specific criteria are eligible for consideration;

• An experienced organizational leader with 15+ years of relevant industry experience in bioanalytical sciences in a in a pharmaceutical company and 10 years of experience in leading cross-functional departments spanning multiple organizational levels;

• Proven track record designing lean and agile operating models, successfully implementing change management approaches and leading organization through change with a strong sense of urgency;

• A critical thinker and strategic leader balancing the need to deliver the current portfolio focusing on resource efficiency and operational excellence with building innovative scientific and operational capabilities (e.g. automation) to support the future portfolio;

• Proven track record of scientific leadership and regulatory accomplishments in bioanalysis of a diverse portfolio of therapeutic modalities as demonstrated through regulatory impact and scientific productivity;

• Extensive knowledge of global regulatory guidelines/ requirements associated with quality and compliance in the conduct of nonclinical and clinical bioanalytical sample analysis;

• In-depth understanding of the drug development and biomarker development process with extensive experience in delivering bioanalytical and immunogenicity assessment strategies supporting a portfolio of diverse therapeutic modalities through all phases of drug development, and a successful track record of global regulatory filings, Health Authority interactions, and approval support;

• Strong, clear, concise, and influential communicator with exceptional influencing skills that demonstrate strong thought partnership and create effective relationships with internal and external stakeholders to ensure delivery of the pipeline;

• Exceptional ability to lead functional groups, identify and develop talent, and delegate effectively with proven capability to lead, motivate, inspire without authority and collaborate effectively in a diverse, global, cross-functional structure;

• Ability to relate, interact, collaborate and influence senior leaders in a global environment.

Relocation benefits are available for this job posting

The expected salary range for this position based on the primary location of San Francisco, CA is $401,795 and $496,335.00. Actual pay will be determined based on experience, qualifications and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance, as well as participation in a long-term incentive program. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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