Late-Stage Clinical Development Leader
Job Description
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 encountered in development and execution of such programs within agreed upon timelines and budget.
Maintain up-to-date knowledge of relevant current guidelines, regulations, and legal frameworks and ensure translation of these into fully implemented and operating Organon processes to secure an industry-benchmarked clinical development and clinical safety organization, operating in full compliance.
Ensure proactive intelligence on evolving regulations, methodology and assess the impact of these to anticipate future developments in order for Organon to remain current and compliant.
Oversee statistical rigor and credibility of study designs, data analysis, and interpretation of results.
Oversee and lead input and execution of statistical analysis plans and assure statistical integrity, adequacy, and accuracy in clinical development plans, clinical protocols, clinical study reports, regulatory documents, publications, and presentations.
Oversight for high-quality data analysis and clinical trial result interpretation based on the study protocol, including studies outsourced to CROs and assure adequate quality and consistency with company and industry standards.
Develop a thoughtful data management strategy to support timely and accurate clinical trial data submissions and new therapeutic research efforts in support of innovation in Women's Health.
Accountable for direct oversight of CROs for all outsourced activities related to clinical trial execution in late-stage clinical development.
Ensure adequacy of the benefit/risk balance in candidate medicines under clinical development and of marketed medicines and devices:
As a member of RDRC and Organon Safety Review Committee (SRC, chaired by the Chief Safety Officer), the R&D Compliance Council, the Medical Affairs Review Committee, and the Recall Committee, ensure comprehensive assessment of benefit-risk, appropriate actions in line with scientific, medical, regulatory and legal guidance for all Organon product candidates and marketed products.
Ensure integration of comprehensive and customer-focused strategic patient safety expertise to clinical development, marketed products, and due diligence of in-licensing opportunities, for effective benefit-risk decision-making and timely delivery of right-quality documents.
Ensure rapid review and strategic assessment of new external pipeline asset opportunities during search & evaluation and business development process.
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 as well as executional oversight in line with Franchise charters.
Ensure communication of Women's Health Franchise priorities, strategies, execution imperatives and timelines to Executive Leadership Team (ELT).
Ensure communication of our Company's R&D perspective at ELT and the Board of Directors at the request of the ELT.
Financial and staffing stewardship of the organization reporting into the Late-Stage Clinical Development:
Effective, proactive and efficient human resource management, in line with project-driven capability and volume needs, in partnership with Finance and Human Resources.
Fiscal stewardship, ensuring proactive management of budget creation and spending, accountable for overall budget for late-stage clinical development studies.
Continued staff development and creation of succession paths
Ensuring vendor oversight for service providers involved in clinical development, clinical operations and data sciences activities at Organon.
Required Education, Experience and Skills
MD specialist, several years of clinical experience exercising medical judgment as a physician. Extensive clinical trial-based experiences with track record of successful negotiation with agencies on protocol, endpoints, evidentiary requirements. (ObGyn, Internal Medicine, or Endocrinology preferred)
At least 15 years of cross functional, diverse R&D experience, across multiple therapeutic areas.
Proven track record in building and leading teams of skilled professionals to deliver business goals.
Experienced in decision-making at a senior level.
Broad industry knowledge with significant cross functional R&D experience, optimally covering the entire commercialization spectrum (phase 1-4).
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. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
US and PR Residents Only
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Search Firm Representatives Please Read Carefully
Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
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. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.
Annualized Salary Range (US)
$363,000.00 - $616,800.00Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1Requisition ID:R524528
