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Late-stage Clinical Development Leader

3 months ago


Plymouth Meeting, United States Organon Full time

**The Position**

The 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 programing 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 as well as support management in facilitating meetings with investors to support financing and business development.
- 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 to ensure seamless progression of development programs over time.

**Responsibilities**

Contribute 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 member of the Organon Senior Leaders team contributing 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 and with the goal to position our Company as a leader in our fields of interest. Proactively, monitor progress vs those objectives and ensure all preventive and corrective actions are taken, as needed, to ensure on time and on budget delivery of such objectives, with quality and compliance.
- 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, with high quality and efficient delivery of focused collaboration.
- 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, supports global registration with regulatory agencies and other health authorities, and enables favorable reimbursement.
- Ensure top quality contribution or leadership to product/project-related external meetings, e.g., Advisory Boards, Health Authority meetings etc., to enable effective communication of company messages, and fruitful answers to questions on R&D matters posed to Organon.
- Ensure sound late-stage clinical study protocol designs that are aligned with approved program strategy and development plan, scientifically sound, feasible to execute, efficient and in line with Good Clinical and Good Pharmacovigilance Practice (GCP and GPvP).
- Ensure excellent understanding of the external dynamics in medical practice, policy, regulatory science and the competitive landscape based on engagement with the relevant functions within our Company and appropriate engagement with external parties, including Scientific Leaders.
- Member of Organon’s Research & Development Review Committee (RDRC) to ensure scientific and medical soundness of development programs, including preclinical, clinical, and registration enabling medical affairs study protocols, stage-gate transitions and mitigations for issues encoun