Mallinckrodt Pharmaceuticals · 1 month ago
Head of Clinical Development
Malvern, PA
Full-time
Hybrid
Director/Executive
$370K/yr - $455K/yr
15+ years expMallinckrodt Pharmaceuticals is a leading company in the pharmaceutical industry, seeking a Head of Clinical Development. The role involves leading the Clinical Development department, overseeing the design and execution of clinical programs, and collaborating with various departments to ensure successful product development and regulatory compliance.
Biotechnology
Responsibilities
Directs clinical development activities
Works with key members of Medical Affairs to support marketed products
Coordinates seamlessly with Clinical Operations and with Regulatory Affairs
Supervises the activities and the performance management of 2-5 direct reports and consultant/contractor resources
Responsible for the department’s budget
Lead portfolio efforts in the design of Phases I through IV clinical programs and responsibility for successful completion of clinical programs within set timelines and budgetary goals
Maintain a comprehensive understanding of the current and emerging practices and approaches to clinical development in the pharmaceutical and biotechnology industry
Manage, develop, and hire personnel that design optimal clinical development plans and protocols for Phases I through IV activities
Participate in the Protocol Approval Committee
Serve as a member of the Safety Review Board
Work seamlessly with Clinical Operations
Consult with commercial, business development and scientific leaders to determine needs and requirements for clinical research
Participate in the development of the strategic plan for acquisition and clinical development of new products in the Company’s pipeline
Maintain a broad understanding of the strategic direction of the overall business and the key functional areas that are critical to Clinical Development
Collaborate with other members of R&D to determine overall strategy including pipeline requirements portfolio development, product life-cycle management, competitive issues, environmental trends, Participate in due diligence activities for potential project/product acquisitions
Lead the clinical contribution to regulatory filings (IND, BLA, NDAs, sNDAs, etc.) for approval of new drugs, new indications, or revision of product labeling
Expertise in GCP, ICH guidelines and ethical considerations
Skills in preparing clinical study reports
Handle and respond to information requests from regulatory agencies
Contribute clinical information to annual NDA reports, annual IND reports, investigator brochures, and other submissions to regulatory agencies
Supervise the activities and mentor direct reports
Develop, review, and adhere to budget
Interact with R&D departments and other operating units to provide advice on drug development
Qualification
Required
Advanced degree MD or MD/PhD in life sciences
Minimum 15 years of drug development experience with an emphasis on late phase clinical development with experience in new medicines approval approvals/launches
Previous management and leadership experience leading teams and managing teams in a matrix environment
Extensive working knowledge of FDA regulations; some exposure to EMEA regulations
Extensive knowledge of the drug development process
Demonstrates ability to exert influence toward goals in a matrix environment
Possesses a sound foundation in clinical medicine and/or drug development combined with the ability to influence with credibility at all levels of the organization
Demonstrates an awareness of pharmacovigilance regulations and methodology
Demonstrates a solid understanding of scientific methodology in the design, conduct, interpretation and reporting of clinical research projects with emphasis on safety monitoring
History of working seamlessly with Clinical Operations
Benefits
Total Rewards package which includes competitive pay and benefits
This position is eligible for a bonus in accordance with the terms of the applicable program
Company
Mallinckrodt Pharmaceuticals
Mallinckrodt Pharmaceuticals combined with Endo in 2025 to better serve customers and improve outcomes for the patients we support.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
unknown2013-07-01IPO
Leadership Team
Paul O'Neill
SVP Quality and Operations, Specialty Brands
Recent News
2025-11-12
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