Our client is a biopharmaceutical company developing novel therapies for the central nervous system. They have asked us to assist them in their search for a Senior Director, Clinical Development.

Major tasks and responsibilities include:

• Leads the creation of and provides scientific insight into study designs and disease area strategy.
• Oversees protocol development, Investigator’s Brochures, annual regulatory reporting, and clinical study reports.
• Collaborates with regulatory and CMC teams to develop and execute program strategies from IND through all phases of clinical development.
• Engages Key Opinion Leaders for innovation approaches to study design and drug development.
• Develops timelines and integrated program plans for the tracking of product and project deliverables.
• Champions and facilitates program team meetings, cross-functional communication and decision making, ensuring alignment with internal and external stakeholders.
• Partners with the Clinical Study Team to oversee the execution of clinical studies.
• Provides scientific insight into study design and disease processes.
• Trains the clinical study team on therapeutic area, drug product, and protocol, as needed.
• Contributes to Clinical Study Reports, and clinical sections of INDs and NDAs (Module 5).
• Drives and presents abstracts, poster presentations, slides, and manuscripts of clinical study findings.
• Authors, reviews, and revises Standard Operating Procedures (SOPs), as needed.
• Contributes to publication planning, authoring and presentation of abstracts, posters, slides, and manuscripts.
• Assists the Medical Monitor with review of subject eligibility.
• Contributes to pharmacovigilance monitoring AEs, SAEs, and FDA reporting and database reconciliation.
• Participates in data review of clinical and safety measures at the patient level and in aggregate to assure subject safety and efficient study conduct.
• Supervises or mentors other Clinical R & D team members.

We seek candidates with the following qualifications:

• A Post-graduate degree is required, science-focused qualifications are strongly preferred, e.g., MS., PharmD, PhD, with at least 10 years of clinical research experience.
• Must have a strong understanding of the drug development process up to and including clinical trial initiation and execution.
• Requires experience in preparing and submitting INDs and NDAs.
• Strong analytical and problem-solving skills with excellent communication is required.
• Must have experience writing clinical and regulatory documents.
• Requires a thorough understanding of FDA, GCP and ICH guidelines.
• Must be comfortable multi-tasking in a fast-paced, small company environment and be able to adjust workload based upon changing priorities.
• Required the willingness and ability to fill functional gaps in a small but growing organization.
• Must be able to travel as needed, up to 20%.
• Requires the ability to work on site Monday, Tuesday and Thursday.

   

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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