Our client is a clinical-stage biopharmaceutical company focused on innovative therapeutics for life threating diseases. They have asked us to assist them in their search for a Senior Director, Clinical Development.

Major tasks and responsibilities include:

• Leads early clinical trial design, including selection of indication, dose cohorts and regimen, safety/PK/PD/efficacy/biomarker development plans, inclusion/exclusion criteria, escalation and stopping rules while working across cross functional teams including pharmacologist, toxicologist, regulatory professionals and management teams.
• Serves as an internal clinical lead in monitoring and management of clinical studies, including the trial execution, medical monitoring, assessment of clinical safety, data accuracy and project timelines that include first-in-human Phase one, proof of concept Phase one/two as well as other biomarker or clinical pharmacology studies.
• Holds responsibility for working with clinical CRO’s and managing daily clinical operations with respect to lead development projects.
• Contributes to the preparation of regulatory filings and serves as a point of contact for any regulators’ questions as received.
• Designs and develops study protocols in a cost-effective manner and analyzes benefits and risk to ensure all study conducts are adherent to protocols.
• Works with clinical CRO on investigator brochures, amendments, data collection systems, other study-relevant documents, and reports for regulatory agencies.
• Serves as an internal resource for functions requiring clinical input including primary acting as the point of contact for clinical trial staff at study sites for clinical issues as well as regulatory, safety and other functions.
• Prepares data interpretation and clinical trial reports, as well as Investigator Alert letters and SAE reports as required.
• Leads in clinical advisory boards, consultant meetings, investigator meetings and at national meetings, including the preparation and delivery of presentations.
• Collaborates with the clinical CRO/PI on the review, analysis, and interpretation of clinical and non-clinical study data, including real-time adverse event monitoring of clinical trial data, ensuring appropriate interpretation, reporting and actions.
• Identifies and evaluates early translational clinical development needs and issues and provides strategy and direction for the management team.
• Ensures the development and implementation of the clinical program strategy and directs systems and programs to meet company goals and objectives.
• Participates in clinical development of additional portfolio company’s product candidates.

We seek candidates with the following qualifications:

• A Medical degree or PhD is required, US board certification is highly preferred.
• A minimum of ten years of experience in clinical development, leading early-stage clinical trials is required.
• Must have a background in immunology with experience in autoimmune disease trials.
• A strong knowledge of clinical trial processes, study designs, statistics, and clinical operations is required.
• Must have a good understanding of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials.
• Must have the ability to operate autonomously in a fast-paced, innovative early phase company while remaining flexible, proactive, resourceful, and efficient.
• Must have a full understanding of the biotech business strategy.
• The ability and willingness to travel as needed 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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