Executive Medical Director, Clinical Development

Proclinical, in support of our client, are seeking an individual to fill the role of Director of Clinical Development, based in Waltham, MA. The successful candidate will play an important role in leading ongoing and future clinical development research activities.

Responsibilities

• Serve as clinical lead for ongoing and future clinical trials, and in conjunction with Clinical Operations, write protocols, conduct clinical trials and review/analyze clinical data results
• Interface with regulatory authorities, as appropriate, in support of the development objectives for drug candidates and assist in the compilation of submissions and in the responses to inquiries; participate in the development of clinical dossiers in support of regulatory filings.
• Participate in publication process for data dissemination, including contributing to development of scientific abstracts, presentations, and manuscripts.
• Plan, prepare, and participate in scientific advisory board meetings
• Develop and maintain relationships with academic investigators, pharmaceutical sponsors/partners, and key opinion leaders.
• Review and approve external proposals in the Investigator Sponsored Research (ISR) program.
• Participate in Medical Legal Regulatory Review Committee and Medical Review Committee as Clinical Representative ensuring medical/scientific accuracy of all submissions.
• Ensure compliance with SOPs, ICH, GCP and other national and international regulatory requirements.

Skills And Qualifications

• MD or equivalent and 5+ years of Pharmaceutical/Biotech industry experience.
• Board certification/eligibility in specialty area desired but not required.
• Strong track record of drug development and demonstrated evidence of cross-functional integration.
• Possess a comprehensive understanding of applicable US and EU regulatory requirements and of the drug development process.
• Have a working knowledge of biostatistics, data management, clinical operations and clinical pharmacokinetic scientific and technical processes.
• Experience in filing and defending US INDs and/or NDAs.
• Excellent written, verbal, and interpersonal communication skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Kaye Dunleavy at (+1) 646-367-2646 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

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

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