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    Late-Stage Clinical Development Leader

    Organon
    2+ years
    $363,000 - $616,800 annually
    Plymouth Meeting
    10 Nov. 15, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Description - Head of Late-Stage Clinical Development

    Position Overview:

    The Head of Late-Stage Clinical Development is a critical role within Organon’s R&D leadership, reporting to the Head of R&D and Chief Medical Officer. This position will oversee the direction of late-stage clinical programs across multiple functions, driving the clinical development strategy, execution, and organizational leadership. The successful candidate will manage teams across Global Clinical Development (GCD), Clinical Trial Operations (CTO), Clinical Data Sciences (CDS), and Late-Stage Asset Development, ensuring seamless execution of high-quality clinical trials and development programs.

    Key Responsibilities:

    • Leadership & Strategy: Lead the Late-Stage Clinical Development teams, setting clear goals aligned with Organon’s broader R&D strategy. Contribute to defining and advancing the R&D vision alongside leadership peers, ensuring the clinical and regulatory strategies are executed efficiently and effectively.
    • Team Development: Directly oversee team leaders and ensure that objectives are aligned with enterprise goals. Support staff growth and development while managing staffing and budgetary needs for optimal delivery.
    • Clinical Development Execution: Ensure the design and implementation of clinical development plans, protocols, and programs that generate reliable evidence to inform decision-making and support global regulatory approvals.
    • Cross-functional Collaboration: Facilitate strong inter-departmental communication and collaboration to achieve business objectives, ensuring timely delivery and compliance across projects.
    • External Representation: Represent Organon’s R&D department in meetings with external stakeholders such as FDA, EMA, investors, and partners. Help shape public messaging and product strategies through participation in advisory boards and external meetings.
    • Financial & Operational Oversight: Manage the budget for late-stage clinical trials and oversee outsourcing operations with Contract Research Organizations (CROs). Ensure fiscal stewardship of clinical programs, including staffing and resource allocation.
    • Risk & Compliance Management: Monitor clinical development progress and implement corrective actions as needed to meet timelines, quality standards, and regulatory compliance.

    Qualifications & Experience:

    • Education: MD, with expertise in ObGyn, Internal Medicine, or Endocrinology (preferred). Extensive clinical trial experience and a proven track record in successful protocol negotiation with agencies like the FDA and EMA.
    • Experience: At least 15 years in R&D leadership, with a broad industry background covering all stages of clinical development (Phase 1-4). Proven ability to lead cross-functional teams, manage large budgets, and navigate complex clinical strategies.
    • Skills: In-depth knowledge of clinical trial design, regulatory requirements, biostatistics, data management, and global registration processes. Strong leadership and decision-making abilities at senior levels.

    Compensation:

    • Salary Range (U.S.): $363,000 - $616,800 annually
    • Other Benefits: Comprehensive health benefits, paid leave, retirement savings, and additional benefits as per company policy.

    About Organon:

    Organon is dedicated to improving health and quality of life for women and their families globally. With a portfolio of trusted products and a focus on Women's Health, Organon is committed to expanding access to innovative treatments and addressing unmet medical needs.

    Organon is an equal-opportunity employer, celebrating diversity in all its forms and committed to creating an inclusive environment for all employees.

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