Medical Director, Clinical Development
Our client is a biotechnology company focused on developing precision medicines. They have asked us to assist them in a search for a Medical Director, Clinical Development.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Executes clinical and regulatory strategy for assets in renal disease including supporting early and late-stage programs.
- Collaborates with physicians, scientists, and regulatory professionals to develop and execute clinical trials from beginning to end.
- Assumes medical responsibility for clinical trials including active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions, and safety data review.
- Ensures that clinical development programs are compliant and conducted in accordance with applicable regulatory requirements and guidelines.
- Guides field medical directors on protocols and messaging.
- Evaluates and trains potential clinical investigators on protocols and clinical data.
- Provides clinical leadership to publication strategy and execution.
- Serves as the medical office accountable for ensuring appropriate precautions are taken to minimize risk to patients participating in clinical studies.
- Updates key documents as new safety information becomes available.
- Develops and maintains strong medical relationships with all external constituents and consultants, including thought leaders, clinical trial investigators, academic centers, community-based trials consortia, and advocacy groups.
- Collaborates with the Vice President of Clinical Development and other key leadership on business development and alliance management issues.
- Contributes to the development and maintenance of a positive team-focused company culture.
- A Medical degree is required along with 5+ years of post-fellowship experience and 3+ years of industry experience.
- Must have expertise in nephrology, immunology, and rare drug development.
- Strong leadership skills to translate corporate objectives into action plans that effectively and consistently deliver high quality data on time and on budget are required.
- Requires experience in the execution of early, mid, and late-stage development programs.
- Must be skilled at critically evaluating business development opportunities from the clinical perspective.
- Must have a thorough understanding of GCP and ICH guidelines governing the conduct of clinical trials.
- Must have a demonstrable track record of identifying and solving difficult clinical development challenges in a competitive clinical trial landscape.
- Excellent written and verbal communication skills, as well as outstanding analytical abilities are required.
- The ability to adapt quickly to changing environments and priorities is required.
- Must have a positive attitude and high personal and ethical standards in achieving corporate goals.
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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