Our client is a clinical stage biotechnology company. They have asked us to assist them in a search for a Medical Director, Clinical Development.  

Major tasks and responsibilities include:

• Designs, develops, and implements clinical plans and protocols based on knowledge of the drug and relevant disease to meet regulatory and commercial targets.
• Leads all aspects of clinical trial delivery, including identification & selection of study sites, patient recruitment, and resolving study issues.
• Builds strong relationships with investigators and study staff resulting in effective patient recruitment and high-quality data collection.
• Identifies and maintains strong relationships with key opinion leaders to gain their input on clinical plans and protocol designs.
• Interprets clinical data and makes appropriate recommendations based on safety and efficacy of the investigational drug.
• Provides clinical content to key clinical and regulatory documents such as investigator brochures, annual safety reports, clinical study reports, IND, health authority briefing documents, and other related study documents.
• Works with the head of clinical operations to set selection criteria and make final decisions on CROs.
• Collaborates with the director of scientific communications to develop data dissemination plans, including presentations and publications in accordance with broader asset strategies.
• Leads and manages study team members to drive collective and individual success.

We seek candidates with the following qualifications:

• A Medical Degree, PhD, PharmD, or equivalent combination of education and applicable experience is required.
• A minimum of five years of drug development experience, specifically in the design, execution, and clinical interpretation of clinical studies is required.
• Experience with both early and late-stage studies is preferred.
• Requires experience managing all aspects of a multicenter clinical study from inception to completion, including scientific and operational monitoring.
• Must have experience in creating clinical research plans, clinical protocols, clinical study reports, and IB’s.
• Experience in respiratory and dermatology therapeutic areas is considered a strong asset.
• Must be able to work effectively with outside vendors and partners.
• Must have excellent verbal and written communication skills with a strong mastery of medical and scientific terminology.
• The demonstrated ability to work effectively with cross-functional teams is required.

 
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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