At Johnson & Johnson Pharmaceutical R&D, we are committed to translating breakthrough science into medicines that make a difference in the lives of patients, their families, their communities, and the health care ecosystem.
We are constantly working to maximize our internal scientific excellence and seek to partner with the best external science available globally. Through this approach, we have become the industry leader in productivity, FDA approvals and breakthrough designations, with 13 new products since 2011 and most NME approvals 2011-2016. We are also one of the fastest growing and most admired pharmaceutical companies.
We have a strong and ever-evolving discovery organization with labs around the world including in Spring House, PA, Beerse, Belgium, Leiden, The Netherlands, Beijing and Shanghai, China, La Jolla and Cambridge, MA. More than 15 new compounds are typically advanced per year into development. We also have one of the very strongest development organizations in the world, committed to working with regulators to progress meaningful medicines, evolving endpoints as needed, using modern and innovative approaches to clinical operations and trial design. We remain committed to our products after they enter the marketplace, continue to support their evolution within the approved indications and explore their value and suitability in new indications.
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ROLEOVERVIEW:
Johnson & Johnson is recruiting for a Senior Director, Global Head of Investigative Pathobiology to be based at our site in La Jolla, CA.
The Global Head of Investigative Pathobiology, Preclinical Sciences and Translational Safety (PSTS) will lead a global network of laboratories and scientists strategically across the La Jolla, Spring House and Beerse campuses positioned to deliver necropsy, histology, molecular pathology and investigative efforts leveraging tissue section-based technologies in support of discovery and development programs, spanning all therapeutic areas and modalities.
The incumbent will be responsible for developing and executing strategies to assure J&J Innovative Medicine R&D maintains world-class laboratory capabilities, capacity and subject matter expertise strength in the interface with the Therapeutic Areas for discovery (e.g., pharmacology models, target expression profiling), investigative issue resolution (including tissue section-based biomarkers), and support to tissue section-based endpoints in toxicologic pathology safety assessments. The head will assure that their strategies and execution are in step with PSTS, DPDS and therapeutic area goals to deliver our mission to patients in an efficient and robust manner.
The incumbent will assure that their team of laboratory scientists and laboratory professionals is seamlessly, globally connected, efficiently managed, and has a strong talent pipeline that has the nimbleness to support the pipeline, end-to-end. The staff for this team is in 3 different global regions including Beerse, Pennsylvania, and California, and comprises histotechnologists, necropsy, and bench scientists (including MS and PhD), as well as outsourced investigative pathology interfaces, to drive pharmacology and safety assessment work both within the discovery/non-GLP/investigative and development spaces.
The incumbent will assure industry best practices to deliver investigative tissue section-based assessments that proactively flag risks associated with our pipeline and provide appropriate context of data for scientific and regulatory reviews and decision-making. The expectations of this role include: shaping appropriate globally united laboratory capabilities and capacity, harmonized with best practices for data integrity and reporting to determine target expression/molecular targets, and histology/pathology/molecular pathology laboratory services to deliver appropriate endpoints for pathobiology and pathologist assessments.
The incumbent will be accountable to assure an industry-leading integrated laboratory organization that directs its work in alignment with portfolio strategies, assuring the prioritization of resource is aligned with portfolio priorities, and provides strong integration and pertinent deliverables to in vivo pharmacology/toxicology studies, molecule/target discovery and de-selection, issue resolution, and robust overall registration dossiers. This role is a standing member of the Pathobiology senior leadership team (SLT) and will collaborate closely with the SLT to ensure alignment of strategies across Pathobiology and PSTS functions.
This role will lead a team of MS/PhD level and technical level staff providing leadership, mentorship, and career development opportunities for their global team members. The candidate will manage staff across two US (La Jolla, CA and Spring House, PA), and one European site (Beerse, Belgium). The incumbent will have responsibility to ensure an optimal organizational shape for portfolio delivery and talent development, to assure a cohesive team that can deliver our diverse and broad portfolio seamlessly and agnostic to geographies. The incumbent will have accountability for globally uniting process to assure optimization of people resource, future capacity planning, budget, resource and timeline commitments for their group. They will be a strong role model regarding the company's commitment to equal employment opportunity and the value of a diverse work force.
The incumbent will have a desire for learning and innovation and continue career development through participation in scientific and regulatory meetings. They will increase visibility for self and J&J Innovative Medicine R&D through participation in external organizations, and presentations at major scientific, industry, and regulatory meetings. The latter is critical to help gain broader consensus and support of new approaches by the regulatory community and for retaining and recruiting future talent.
RESPONSIBILITIES:
- Leadership of the global investigative pathobiology labs team: managing staff, strategic planning capacity and capabilities to meet portfolio needs, assuring prioritization targeted toward impactful portfolio work that drives internal decision, and assuring compliance and quality of output from laboratories. Develops strategies for assuring proactivity in pipeline work, anticipates future modality/innovation needs, engages external stakeholder network to inform research priorities.
- Member of the Pathobiology senior leadership team (SLT) and contributes to strategic and long-range planning for Pathobiology business and staff development needs.
- Builds and fosters a network of scientific interface with the Therapeutic Areas (TA) for optimal and strategic discovery portfolio support (e.g., pharmacology model characterization and optimization). Accountable for external investigative pathobiology-CRO interfaces.
- Participate in cross-functional DPDS strategic teams, external outreach, J&J Innovative Medicine R&D leadership representative at external science or regulatory forums as pertinent.
Qualifications
EDUCATION AND EXPERIENCE
• Ph.D. in toxicology, pathology, veterinary or clinical medicine or related discipline (bioengineering, medicine, veterinary science or related field) and professional degree (DVM) with training or extensive experience in molecular pathology and pathology laboratory sciences, and DAVCP.
• Minimum of 10 years required (15 + years preferred) of pharmaceutical/biotechnology research management, coincident with experience in drug development and people leadership.
• Proven track-record in leading scientific teams, including direct people management experience and matrix coordination across departments/functions, including direct or matrixed management of pathology scientists and pathologists, directed toward mechanistic pathobiology scientific resolution and toxicology submissions.
• Exceptional interpersonal skills, diplomacy and negotiating skills, troubleshooting skills and ability to work effectively in a collaborative environment and to help coach and mentor staff similarly.
• Exceptional communication skills, including the ability to assure full clarity on intent, and audience-appropriate content, with respect to investigative strategies, scientific integration of complex datasets, and communication of results (both oral and written for various stakeholders) for timely decision making.
• High level of organizational ability and attention to detail with respect to managing aspects of business, budget, HR, legal, compliance, laboratory safety, etc. and other operational components.
• Strong change, process management and organizational skills; knowledge of good laboratory and industry best practices, data security/integrity standards, and regulatory submission requirements
• Should be an experienced "drug hunter"- with practical experience in directly driving a diverse therapeutic portfolio.
• Experience in working with senior leaders across therapeutic areas within pharma.
• Experience in serving as a pathologist in a pharmaceutical company as a primary and project pathologist.
• Recognized/Established expert in pathology and toxicology study execution, and applied toxicology for driving submissions to advance candidate therapeutics toward regulatory approval, knowledge of GLP regulations and submission standards, track record of successful interactions with cross-functional drug development community, regulators, and a breadth of the toxicology, pharmacology, pathology experts.
• Experience in building and driving successful partnerships with outsourced organizations.
• Experience in managing a pathology laboratory.
• Experience in managing a pathology sciences-based team, including direct or matrixed leadership of pathologists.
• Strong scientific acumen with ability to evaluate problems from a "systems biology" and translational lens
• Knowledge of basic tools of data sciences and data visualization.
• Change management experience.
The anticipated base pay range for this position is $226,000 to $391,000 USD.
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long term incentives, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.