Late-Stage Clinical Development Leader

Job DescriptionThe PositionThe Head of the Late-Stage Clinical Development organization is a member of the Organon Research and Development (R&D) Leadership team, reporting to the Head of R&D and Chief Medical Officer, and is accountable for:The leadership of the following teams: Global Clinical Development (GCD), Clinical Trial Operations (CTO), Clinical Data Sciences (CDS) that includes Biostatistics, Statistical programming and Data Management, and the Late-Stage Asset Development Team leaders.Design of the clinical development strategy for all late-stage programs at Organon.Oversight, direction, and execution of late-stage clinical development programs at Organon.Co-chairing the Women’s Health Franchise, as representative of the R&D organization, ensuring the cross-functional perspective of R&D is integrated into the overall franchise strategy.Financial and staffing stewardship of the organization reporting into the Late-Stage Clinical Development organization.Representing our Company's R&D and providing clinical leadership in interactions with various external audiences, including FDA, EMA, corporate partners, boards of directors, future investors and other key stakeholders.In collaboration with other members of our Company's R&D Leadership Team, build and extend external stakeholder network of key medical and scientific leaders, biotech/pharma/device innovators, and non-government entities in all therapeutic areas of interest to our Company.Establish and advance the guiding principles, policies and procedures that guide clinical development at Organon in close collaboration with the Head of Early Clinical Development and Translational Medicine.ResponsibilitiesContribute to advancing Organon's R&D strategy and direction:Represent the Late-Stage Clinical Development organization at the Organon R&D Leadership Team.Contribute to defining and advancing the strategy for the broad R&D organization in collaboration with all other members of the leadership team.Contribute to setting the objectives for the broad R&D organization, tracking the collective performance, and proactively managing issues and risks.As a member of the Organon Senior Leaders team, contribute by driving our Company into the future by working proactively and collaboratively with senior leaders from other areas.Leadership of the following teams: Global Clinical Development, Clinical Trial Operations, Clinical Data Sciences, and Late-Stage Asset Development Team Leaders.Ensure clear objectives are set for the divisions, teams, and individuals in the Late-Stage Clinical Development organization, in line with enterprise strategic objectives.Directly and through the organization, inform and contribute to the Clinical and Regulatory strategies for all development programs.Ensure adequate cross-functional connectivity within and outside the organization reporting to the role.Enable staff development in line with enterprise strategic needs and talent base.Strategy, direction, and execution of Organon’s clinical development plans:Ensure soundness of clinical development strategies, aiming to efficiently generate evidence that allows internal decision making.Ensure top quality contribution or leadership to product/project-related external meetings.Ensure sound late-stage clinical study protocol designs that are aligned with approved program strategy and development plan.Ensure excellent understanding of the external dynamics in medical practice, policy, regulatory science and the competitive landscape.Member of Organon’s Research & Development Review Committee (RDRC) to ensure scientific and medical soundness of development programs.Maintain up-to-date knowledge of relevant current guidelines, regulations, and legal frameworks.Ensure proactive intelligence on evolving regulations and methodology.Oversee statistical rigor and credibility of study designs, data analysis, and interpretation of results.Accountable for direct oversight of CROs for all outsourced activities related to clinical trial execution.Ensure adequacy of the benefit/risk balance in candidate medicines under clinical development:As a member of RDRC and Organon Safety Review Committee (SRC), ensure comprehensive assessment of benefit-risk.Ensure integration of comprehensive and customer-focused strategic patient safety expertise to clinical development.Ensure rapid review and strategic assessment of new external pipeline asset opportunities.Integration of R&D strategic and tactical perspectives in the Women’s Health Franchise:Co-chair role on Women’s Health Franchise teams and provision of R&D enterprise perspectives into strategy development.Ensure communication of Women’s Health Franchise priorities to Executive Leadership Team (ELT).Ensure communication of our Company's R&D perspective at ELT and the Board of Directors.Required Education, Experience and SkillsMD specialist with several years of clinical experience exercising medical judgment as a physician.At least 15 years of cross-functional, diverse R&D experience.Proven track record in building and leading teams.Experienced in decision-making at a senior level.Broad industry knowledge with significant cross-functional R&D experience.Who We Are:Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for.Applicable to United States Positions Only:

Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job.Annualized Salary Range (US)$363,000.00 - $616,800.00Employee Status:

RegularRelocation:

No relocationVISA Sponsorship:

Not applicableTravel Requirements:

Organon employees must be able to satisfy all applicable travel and credentialing requirements.Number of Openings:

1Requisition ID: R524528

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