Executive Director Clinical

Reporting to the Chief Medical Officer and Vice President of Clinical Research, this Director will have the following responsibilities:

 

 

Primary Responsibility:

 Responsible for preparing the overall strategy for clinical development plans, clinical protocols, and clinical study reports for assigned compounds under development to achieve successful registration for desired indications.  Establishes relationships with external scientific and medical consultants to ensure state-of-the-art plans and protocols.

 

 

Level of Responsibility:

 Works on complex problems of diverse scope where analysis of data requires an in-depth evaluation of various factors.  Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.  Ensures schedules and performance requirements are met.  Erroneous decisions will result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities.  Regularly interacts with senior management or executive levels on matters concerning several functional areas. Requires the ability to change the thinking or, or gain acceptance of others in sensitive situations. 

 

Specific Responsibilities:

 Represent Clinical Research on Product Development teams.Draft and maintain the Clinical Development Plan (CDP) (Powerpoint slide set) for assigned compounds under development, including synopses of protocols under discussion and coordinating input from Regulatory Affairs, Clinical Operations, Biostatistics & Data Management, Corporate Management and consultants.Design clinical trials and write clinical study protocols and protocol amendments to support successful marketing application (s) for assigned compounds under development.Prepare clinical sections of Investigator Brochures (IBs) for original INDs and annual updates to IBs in collaboration with Drug Development colleagues.Participate in the preparation of Clinical Study Reports.Draft clinical portions of briefing documents and IND Annual Reports for submission to regulatory agencies.Build relationships with clinical consultants regarding clinical development plans and clinical study design and analysis of results.

 Write and maintain clinical SOPs, templates, and Work Practice Documents as assigned.Obtain expertise where necessary from internal and external sources to identify strategic issues and directions, identify changes in medical practice, apply translational research to clinical trial design, use biomarkers and surrogate endpoints to accelerate clinical development, and identify new opportunities for compounds under development. 

 

 

QUALIFICATIONS:

 Requires a PharmD, PhD or MD in a relevant scientific discipline/medical specialty and 5 – 8 years experience in clinical research in pharmaceutical industry. Project experience  within and outside the U.S. is required.  Requires the ability to ability to interpret clinical trial efficacy and safety results and change the thinking of or gain acceptance of others in sensitive situations.Demonstrate willingness and ability to take initiative in planning and problem solving.  Prefer experience in Phase 1 – 3 clinical development