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Job Information

J&J Family of Companies VP, Global Head Bioanalytical in Spring House, Pennsylvania

Janssen R&D is currently recruiting for a VP Global Head BioAnalytical. This position can be located at any US Janssen R&D site or Beerse, Belgium, with a very strong preference to be based in Springhouse, PA.

The VP of BioAnalytical is accountable for overseeing the Bioanalytical functions of the company; together with functional leaders within the Bioanalytical organization and Preclinical Sciences & Translational Safety (PSTS) Senior Leadership Team, with the aim of optimizing the therapeutic benefit and safety of the pipeline “end to end” through modality agnostic characterization of pharmacology and exposure parameters. In addition, the candidate will be responsible for the development, maintenance of Quality Systems and Infrastructure appropriate for developmental programs across all molecular modalities and in compliance with Good Laboratory Practice (GLP), and Good Clinical Practice (GCP) regulatory (ICH, FDA, EMA, etc.) requirements. The incumbent will report directly to the Global Head of Preclinical Sciences & Translational Safety.

Essential Duties and Responsibilities:

Organizational Leadership

  • Responsible for the overall operational success of the bioanalytical laboratories, which includes, but is not limited to monthly reporting, business forecasting, budgeting, making decisions on capital expenses, managing senior staff.

  • Continually assesses and develops operating procedures and processes to achieve maximum efficiencies for the business utilizing and directing process excellence methodology and resources; defines and leads process improvements to reduce costs and improve efficiency providing for current and future programmatic needs.

  • Directs the development and implementation of, and ensure appropriate compliance with operational policy and procedures; develops training programs and implement with corporate resources

  • Provides the necessary planning, organization, direction, and control to meet the global strategic operation goals of the company

  • Provide leadership in developing Strategic Operating Plans for the company and manage the execution of such plans and the associated budgets for the bioanalytical group.

  • Provides leadership for the overall operating performance and business continuity and responsibility for therapeutic area management and stakeholder satisfaction.

  • Oversees and manages monthly, quarterly, and annual operational budget; makes decisions on resource strategies and implements accordingly.

  • Responsible for compliance with governmental and regulatory standards by sustaining quality personnel, processes and procedures that understand and support corporate business goals and to ensure continual professional development of all employees.

  • Accountable for the timely design, execution, and approval of analytical development activities in support of discovery projects, patent applications, publications, IND and NDA/BLA submissions

  • Supervises the cross-site management and facilities in conjunction with finance and corporate space planning

  • Assure a high performing, technically strong team. Hire employees, mentor, and advise, promote employees, assign, and evaluate work, terminate employees, review performance annually. Provide development opportunities and mentoring to the team members with an eye towards strategic succession planning.

  • Contribution to regulatory negotiations including strategy for regulatory responses and consultation

  • Contribute to overall research and operational strategy as a member of the Preclinical Sciences & Translational Safety (PSTS) Senior Leadership Team.

  • Potentially serve as delegate or in the succession line for the Global Head of the PSTS Department or as leader of a Drug Discovery Portfolio Committee or other cross-functional strategic team

  • Strong strategies to attract, develop, and retain diverse talent and drive highly inclusive teams

    Scientific Leadership

  • Establishes and maintains professional business/scientific relationships with global partners, industry officials, and key scientific thought leaders.

  • Assists/overseas corporate assessment of M&A targets and takes key role in establishing integration and operational planning.

  • Assesses technology and systems to support technical, regulatory, and scientific trends across all drug modalities for discovery through development stages.

  • Interacts routinely with internal partners to define operational strategies and expectations for project milestone progression and assure Therapeutic Area satisfaction.

  • Develops and implements global operational and technical strategies across sites to insure process and technical excellence and programmatic success for all modalities

  • Evaluates operational processes and procedures, and develops strategies and implementation plans to improve and standardize all aspects of bioanalytical operations at a global level

  • Responsible for the supervision, organization, and coordination of all technical activities of global personnel responsible for drug discovery and development.

  • Responsibility as a key contributor for nonclinical development and early clinical portfolio and program strategy including recommendations regarding ‘go/no-go’ decisions related to further development of assets, particularly when based upon appropriate supporting data.

  • Ensure appropriate quality of documentation for internal studies compatible with requirements for global regulatory submissions

  • Accountable for supporting/overseeing a state-of-the-art laboratory activity across multiple geographic locations and time zones.

  • Responsible for bioanalytical-related activities, will identify and manage the consultants and vendors engaged in supporting program needs studies.

  • Will play a key role in due diligence activities and recommendations to support candidate in-licensing.

  • Determine future global strategy for capacity needs and/or sourcing work in creative models that drive efficiency through leverage of external partnerships.

    The head of this team will be accountable for assignment of scientific leads to projects and assuring the prioritization of resource is aligned with portfolio priorities. This VP role will serve as a delegate for the Global Head of PSTS as needed and could be considered as a potential successor for this role.

    The candidate will manage PhD level scientists across two US (La Jolla, Spring House) and one European site (Beerse, Belgium) with matrix leadership to other regions such as Asia-Pacific. The candidate will have responsibility for talent development to assure a team that can deliver the diverse and broad portfolio, end to end. They will have accountability for globally uniting processes and cultural principles to assure optimization of people resource, future capacity planning, budget, resource, and timeline commitments for the group. They will contribute to the development of project team members/leaders, scientific experts, and people managers across PSTS to assure support for the recruiting and development of to assure strong succession for key scientific areas. 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 Global Head of Bioanalytical 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, Janssen R&D, and J&J 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 recruiting future talent.

Qualifications

  • Minimum of 15 years of post-PhD industry experience in translational science or pharmaceutical development (preferably Analytical Chemistry), with proven ability to manage and work in cross-disciplinary teams effectively and successfully.

  • Highly motivated individual who has demonstrated strengths working in a team context. Must possess excellent communication, collaboration, and influencing skills, and have the aptitude for managing direct reports.

  • Familiar with all relevant FDA guidances and ICH documents and a demonstrated track record of writing technical reports to support regulatory filing, patent applications and publications. Familiarity with GLP/GCP regulations and expectations.

  • Strong attention to detail and scientific writing skills, ability to manage complex tasks, highly organized, dependable, and able to prioritize competing demands to meet deadlines.

  • Demonstrated experience in developing and establishing analytical strategies required for early, late, and commercial stage small molecule/biological/ RNA ASO or siRNA/ therapy assays.

  • Proven ability to work in a matrixed, collaborative, and goal-oriented environment to effectively and transparently manage multiple projects and resources to achieve company goals.

  • Strong bioanalytical skills and familiarity with approaches and methods to allow sensitive and robust quantitation of drug candidates across a broad array of analytical technologies.

  • Proficiency and practical knowledge of method development, troubleshooting, qualification and validation in accordance with regulatory guidelines.

  • Strong attention to detail and scientific writing skills, ability to manage complex tasks, highly organized, dependable, and able to prioritize competing demands to meet deadlines.

  • Experience in being a manager and coaching high potential talent.

  • Exceptional diplomacy and negotiating skills

  • Excellent communication skills, attention to detail, troubleshooting skills and ability to work effectively in a collaborative environment

Primary Location

United States-Pennsylvania-Spring House-Welsh & McKean Roads

Other Locations

Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2105987250W

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