Senior Medical Director - Clinical Development

At Proclinical, we are seeking an experienced individual to fill the role of Senior Director of Clinical Development, based in Boston, MA.

Responsibilities

• Hands-on involvement in the design and writing of oncology clinical study protocols from first-in-human phase 1 through phase 2 and phase 3 pivotal studies that will support regulatory approvals.
• Act as medical monitor for multiple ongoing clinical trials.
• Write clinical sections of key documents.
• Provide strategic leadership in the existing and planned clinical programs to support global filings
• Provide medical review, assessment and interpretation of all clinical data reported in clinical study reports to ensure that the data are correct and presented with the appropriate medical interpretation.
• Ensure timely filing of all clinical applications.
• Work closely with Pharmacovigilance on development of Risk Management Plans
• Ensure consistency of practices with the highest compliance standards.
• Serve as the clinical face of the company both internally and externally.

Skills And Qualifications

• MD with Board Certification or Board Eligibility in adult or pediatric oncology and/or hematology.
• Extensive experience in the biotechnology or pharmaceutical industry.
• Understanding of the drug development process from IND through NDA.
• Strong written, verbal, and interpersonal communication skills.
• Ability to travel domestically and internationally, approximately 25%.

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 James Stevens at (+1) 6466930610 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.