Executive Director, Clinical Research
Our client is a pharmaceutical company. They have asked us to assist them in a search for an Executive Director, Clinical Research.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Leads execution of key business objectives or projects within the department.
- Participates in developing, modifying, and executing company policies that affect immediate operations and may also have company-wide effect.
- Makes decisions that can impact overall business goals.
- Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
- Analyzes gaps in current work processes and recommending enhancements.
- Exercises judgment and discretion on a consistent basis within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
- Interacts with other professionals and internal customers and externally, with peers in other biopharmaceutical companies, federal officials, external customers, vendors, regulatory authorities, etc.
- Influences, advises on, and interprets relevant issues.
- Supervises a team of professionals or leads teams within a project setting.
- Designs and provides oversight of clinical programs in collaboration with strategic marketing functions and business cases.
- Oversees CDPs and DDPs for marketed products and developmental compounds.
- Oversees and resolves operations aspects of clinical studies in conjunction with project and study teams and in accordance with SOPs, GCP and regional regulations.
- A Medical Degree is required. A medically trained Neurologist with industry experience focused on dementia/Alzheimer’s is ideal.
- Must have at least six years of pharmaceutical industry clinical development experience in oncology or neurology with knowledge of translational, Phase I, II, and III studies.
- Requires demonstrated experience as a Study Director or equivalent role.
- Experience managing physicians and non-physician employees is preferred.
- Must have current experience working with FDA or EMEA regulatory agencies handling responses to inquiries and requests for study related information.
- Must have experience and understanding of running clinical studies with understanding of Clinical Operations and Data Management.
- Requires the ability to influence without authority.
- Requires 10-15% travel, both domestic and international.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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