Senior Medical Director, Clinical Development
Proclinical is currently recruiting for a Senior Medical Director of Clinical Development for a pharmaceutical company located in Cambridge, MA. Successful candidate will oversee the design and implementation of multiple clinical development programs in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, their customers, markets, business operations, and emerging issues.
- Lead clinical study teams, monitor overall study integrity, and review, interpret, and communicate accumulating data pertaining to safety and efficacy.
- Along with Clinical Operations, ensure agreed-upon study enrollment and overall timelines for key deliverables. Assess and report serious adverse events per corporate policy and regulations for those protocols on which assigned.
- Design, analyze, interpret, and report scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
- Oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.
- Serve as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinate and lead appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects.
- Participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contribute in partnership with Discovery colleagues to design and implement translational strategies.
- Act as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
- Responsible for understanding the regulatory requirements related to the clinical studies and drug development and accountable for complying with those requirements. Serve as a clinical representative for key regulatory discussions.
- Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
Skills and Requirements:
- Requires MD with relevant therapeutic specialty. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
- 10+ years' clinical trial experience in the pharmaceutical industry.
- Ability to run a complex clinical research program independently.
- Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.
- Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.
- Must possess excellent oral and written English communication skills.
- Ability to exercise judgment and address complex problems and create solutions for one or more projects.
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 Brendan Dunn at (+1) 646-481-1930 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.
Proclinical Staffing is an equal opportunity employer.