Executive Director, Head Of Clinical Operations

10+ years

Not Disclosed

New York

10 Jan. 18, 2025

Job Description

Job Type: Full Time Education: BA/BS 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

Position: Executive Director, Head of Clinical Operations
Location: New York, NY 10022
Employment Type: Direct Hire/Perm
Job Category: Clinical Development and Operations
Job Number: 616645
Is Job Remote?: No
Country: United States

Job Overview

The Executive Director, Head of Clinical Operations will report to the Vice President, Head of Operations and Program Management. This individual will lead Global Clinical Operations for client Development Programs, ensuring successful planning and execution of clinical trials within timelines, quality standards, and budget. The Executive Director will also oversee adherence to regulatory requirements and company SOPs while managing both internal and external resources for clinical trial activities.

Key Responsibilities

Represent Development Operations on the Program Team and contribute to drug development strategy and planning.
Provide actionable operational insights for clinical development programs, including operational timelines, enrollment models, and patient population assessments.
Ensure clinical studies are executed within timelines, on budget, and meet quality standards (ICH/GCP, Global Regulations).
Manage the development of cross-functional study/program costs and financial updates.
Build collaborative relationships with internal and external stakeholders.
Maintain a state of inspection readiness for Clinical Programs and act as an expert during regulatory inspections.
Provide leadership to the global clinical operations team, overseeing the development and training of team members.
Manage the clinical operations budget for all development programs.
Oversee the development and implementation of study plans, enrollment projections, site feasibility, and risk mitigation strategies.

Required Qualifications

BA/BS in life sciences, scientific, or related discipline, or equivalent experience.
10+ years of experience in pharmaceutical, biotechnology, or CRO environments leading global clinical trials (Phase 1 to Phase 3 and post-marketing).
In-depth knowledge of GCP and ICH guidelines, FDA, and EMA regulations.
Proven leadership skills in a global clinical environment.
Experience with contract negotiation, management, and clinical operations budgeting.
Ability to work independently and collaboratively in a fast-paced environment.
Willingness to travel domestically and internationally as needed.

Additional Information

Planet Pharma is an equal opportunity employer committed to diversity, equity, and inclusion.

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Executive Director, Head Of Clinical Operations

Job Description

Job Overview

Key Responsibilities

Required Qualifications

Additional Information

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