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Careers > Clinical Development Director

Working with the Vice President, Clinical Development this position will manage and coordinate efforts in the clinical development process for our clinical programs. This position will assume responsibility for overseeing design, planning, monitoring and implementation of all activities required to effectively execute Phase I – IIl clinical studies U.S and Global.

Responsibilities:

• Implement clinical development Plan for Phase 1 through late stage development project.
• Lead / Monitor clinical programs involving trials in support of U.S and E.U registration of product.
• Direct and manage clinical development program for PR-171 myeloma including company sponsored studies.
• Manage timely completion and analysis of pivotal myeloma studies. This includes preparation of studies, monitoring, execution and analysis of data; preparation of study reports for regulatory filing; ensure studies are completed on time within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.
• Manage clinical personnel, including Clinical Project Managers, CRAs and contractors.
• Participate in strategic planning activities and the preparation of clinical development plans and budgets.
• Assist Regulatory Affairs in the preparation and review of U.S. and international regulatory filings.
• Assist in the recruitment of study centers and the development of strong working relationships with investigators.
• Participate in the designing of clinical studies, the development of protocols and the preparation of clinical and regulatory reports.
• Interact with opinion leaders and regulatory agencies in U.S and EMEA; act as clinical scientist on cross-functional   teams interfacing with in a matrix environment with Regulatory Affairs, Global Clinical Operations, Project Management, as well as with Preclinical Development for championing and executing strategic clinical plans.

Qualifications:

• 5 + years relevant industry experience (would consider1-3+ years for Associate Director)
• Thorough knowledge of FDA regulatory requirements and ICH/GCP guidelines essential.
• Demonstrated proficiency in the implementation, monitoring and management of clinical trials.
• Demonstrated management and/or supervisory skills.
• Broad knowledge and cross functional understanding of clinical trial methodology.
• Proficient in the use of modern management and communication tools.
• Computer proficiency (PC-Windows preferred)
• Willingness to travel (up to 30%) as necessary, consistent with project needs.

Education:

• Advanced degree in a life sciences discipline, M.D., or Pharm.D. preferred. Training in Oncology/Immunology strongly preferred.

Please send all inquiries to careers@proteolix.com. No agencies please.

Proteolix offers competitive compensation and benefits, equity participation, and an interactive, professional environment that recognizes/rewards achievements. We are proud to be an equal opportunity employer.

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