Head of Clinical Development

Job Title

Head of Clinical Development

Requisition

JR000015512 Head of Clinical Development (Open)

Location

Bridgewater, NJ

Additional Locations

Malvern, PA, Philadelphia, PA

Job Description Summary

Job Description

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.

Scope of Authority:

• 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.

Key Responsibilities:

Clinical Development

• 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

Expansion of Product Pipeline and Portfolio

• 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

Regulatory Submissions and Interactions

• 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,