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Late-Stage Clinical Development Leader

Organon
Organon
2+ years
$363,000.00 - $616,800.00
10 Oct. 16, 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

The Position

The Head of Late-Stage Clinical Development at Organon is a vital member of the Research and Development (R&D) Leadership team, reporting directly to the Head of R&D and Chief Medical Officer. This role encompasses:

  • Leadership: Overseeing teams including Global Clinical Development (GCD), Clinical Trial Operations (CTO), and Clinical Data Sciences (CDS), which includes Biostatistics, Statistical Programming, and Data Management, along with Late-Stage Asset Development Team leaders.

  • Strategy Design: Developing clinical strategies for all late-stage programs at Organon.

  • Execution Oversight: Directing and executing late-stage clinical development programs.

  • Cross-Functional Collaboration: Co-chairing the Women’s Health Franchise, ensuring the integration of R&D perspectives into franchise strategies.

  • Financial Stewardship: Managing financial and staffing needs within the Late-Stage Clinical Development organization.

  • External Representation: Providing clinical leadership in interactions with external stakeholders, including regulatory agencies and investors.

  • Networking: Collaborating with R&D Leadership Team members to build and maintain relationships with key medical and scientific leaders.

  • Policy Development: Establishing guiding principles and procedures for clinical development, ensuring seamless progression of development programs.

Responsibilities

Contribute to R&D Strategy

  • Represent Late-Stage Clinical Development within the R&D Leadership Team and contribute to the broader R&D strategy.

  • Set objectives and track performance, proactively managing issues and risks.

  • Work collaboratively with senior leaders to drive the company forward.

Leadership

  • Set clear objectives for divisions and teams, aligning with enterprise strategic goals.

  • Monitor progress against objectives, taking necessary actions to ensure timely, quality, and compliant delivery.

Clinical Development Strategy

  • Ensure sound clinical development strategies to generate evidence for internal decision-making and regulatory submissions.

  • Lead high-quality contributions to external meetings and ensure scientifically sound study designs.

  • Stay informed about medical practices, policies, and regulatory dynamics to ensure compliance and strategic alignment.

Data and Safety Oversight

  • Oversee statistical rigor and ensure high-quality data analysis and interpretation of clinical trial results.

  • Develop data management strategies to support timely clinical trial data submissions.

  • Ensure benefit-risk assessments for candidate medicines and marketed products.

Women's Health Integration

  • Co-chair Women’s Health Franchise teams and align R&D perspectives with franchise strategies.

  • Communicate priorities and strategies to executive leadership.

Financial and Staffing Stewardship

  • Manage human resources efficiently in alignment with project needs.

  • Ensure budget management for late-stage clinical development studies.

  • Develop staff and succession planning strategies.

Required Education, Experience, and Skills

  • Education: MD with extensive clinical experience (ObGyn, Internal Medicine, or Endocrinology preferred).

  • Experience: At least 15 years of cross-functional R&D experience with a proven track record in leading teams and delivering business goals.

  • Decision-Making: Experienced in senior-level decision-making across multiple therapeutic areas.

Who We Are

At Organon, we are committed to delivering innovative health solutions that empower individuals to live their best lives. With a focus on Women’s Health, we are dedicated to making a significant impact on women and their communities through a diverse portfolio of health solutions.


Additional Information

  • Accommodations: If you require reasonable accommodations during the application process, please contact us at staffingaadar@organon.com.

  • Diversity Commitment: Organon embraces diversity and is committed to equal opportunity employment.

  • Search Firm Policy: Organon does not accept unsolicited assistance from search firms for this position.

  • Salary Range: The annual salary for this position ranges from $363,000 to $616,800.

  • Work Arrangements: Flexible work arrangements are available.

  • Travel Requirements: Employees must meet all travel and credentialing requirements.


This job description outlines the key responsibilities and qualifications for the Head of Late-Stage Clinical Development at Organon. We invite qualified candidates to apply and contribute to our mission of improving women's health worldwide.