Head of Clinical Development

Mallinckrodt Pharmaceuticals•Bridgewater, NJ

27d

About The Position

The Head of Clinical Development is a senior member of the R&D Leadership team with responsibility for supporting the strategy for and assuring clinical development of new products and lifecycle management endeavors. Primary responsibilities include leading the Clinical Development department including the hiring and development of personnel for those teams. The Head of Clinical Development will lead the development team in the design of Phases I through IV clinical programs and have responsibility for successful completion of clinical programs within set timelines and budgetary goals. The Head of Clinical Development plays a leadership role in working with other senior managers within R&D and across the enterprise in defining regulatory strategy, developing programs to support commercial strategy, building the pipeline by working closely with business development and ensuring that the clinical group as a whole executes clinical programs to highest standards and with optimal cost-efficiencies, including optimal use of external resources. Further responsibilities including leading the clinical contribution to regulatory filings and handling information requests from regulatory agencies as well as working closely with the Medical Directors of Medical Affairs to ensure that marketed products are appropriately supported. There must be a seamless relationship Clinical Development and the Clinical Operations departments.

Requirements

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

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.
In-depth understanding of the drug mechanisms PK and PD and therapeutic landscape
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