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The successful candidate will be involved in leading cross-functional teams in the design, implementation, monitoring, analysis, and reporting of studies within one or more programs. The successful candidate will also work closely with the Clinical Development and Regulatory teams to support the development of program deliverables to support the drug development plan.

Skills & Requirements:

• M.D./MD Ph.D. with significant experience in drug development
• Strong understanding of the full lifecycle of the drug development process
• Experience in cellular and gene therapies is strongly preferred
• Proven success record in the design and conduct of clinical trials
• Board certification, or eligibility, in Oncology, Hematology, Hematology/Oncology, or related specialty is preferred
• Familiarity with FDA and EMA regulations processes and guidances/guidelines
• Excellent interpersonal, negotiation, problem-solving, communication, and analytical skills
• Proficient in writing protocols, reports, and regulatory documents
• Ability to work independently as well as part of a team in a highly dynamic, fast-paced, matrixed environment with rapidly evolving priorities

The Executive Director, Clinical Program Lead - MD responsibilities will be:

• Provide clinical leadership for all clinical deliverables for the program
• Develop and execute drug development strategies across all stages of clinical development
• Collaborate with clinical investigators, KOLs, and regulatory agencies to deliver effective and timely study protocols
• Contribute to the preparation/review of regulatory documents
• Provide ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance
• Ensure adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice
• Coordinate the collection and analysis of clinical data for internal and external analysis and review
• Prepare presentations for scientific conferences, clinical study investigator meetings, and expert advisory meetings
• Develop manuscripts for publication in peer-reviewed journals
• Provide scientific and clinical guidance to all clinical development, preclinical, regulatory, and project management staff

If you are having difficulty in applying or if you have any questions, please contact Damian Albera at d.albera@proclinical.com

̽»¨ºÏ¼¯ is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

̽»¨ºÏ¼¯ Staffing is an equal opportunity employer.

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