Late-Stage Clinical Development Leader

2+ years

$363,000.00 - $616,800.00

Plymouth Meeting

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.