Director, Clinical Research

Department: Executive
Location: Cambridge, MA
 

Senior Clinical Scientist

What痴 in it for you?

You値l be the glue that holds our clinical programs together in many ways. You will use your strategic insights to provide scientific support for many clinical activities, and help us build clinical expertise in new therapeutic areas. Forming close partnerships with clinical operations, you値l employ your expertise to mentor and train new medical monitors (MDs) how to write protocols and how to present medical data in a concise, consistent, and compelling manner. You will assist them by writing draft manuscripts (paper, abstracts, posters, etc.) review and summarize relevant literature. With your knowledge of clinical drug development, you値l have a tremendous impact as you contribute to the creation and maintenance of clinical development plans ultimately leading to critical decision points for our key trials. Additionally, you値l report to the Chief Medical Officer and collaborate closely with clinical monitors, clinical operations, program management, biostatistics, and data management.  

How do you know if you池e the right fit? 

With your comprehensive understanding of the drug development process in all phases of testing, you値l enjoy contributing to the clinical strategy and creation of the clinical development plans while working as part of an integrated team. You値l desire to identify and cultivate relationships with external partners such as clinical investigators, clinicians, scientists, and vendors. Your experience in providing support to advisory boards, consultant meetings and investigator meetings (including preparation and delivery of presentations) will come in handy. You will have great references that can attest to your skill at collaborating with the clinical development team on the review, analysis, and interpretation of study results; and, most importantly, your ability to author clinical sections of regulatory documents such as INDs, Investigator Brochures, CTAs, ISE痴, Clinical overviews, Health Authority responses, PSUR, and DSUR is impeccable.  You値l also be someone who gets excited about data! You値l love to make sure it痴 accurate, timely, and be able to use it to articulate a compelling scientific story.

The other stuff

This is typically a role best suited for an MS, PhD or PharmD, or equivalent with clinical research experience and a strong knowledge of drug development. You値l need at least 3 - 5 years of experience in planning, reporting and publishing clinical studies, a strong scientific background with industry clinical research experience. Most helpful in your success is a thorough understanding of ICH, GCP, and relevant regulatory requirements, and strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (clinical ops, reg, QA) and clinical investigators. You may be traveling up to 10% of your time.  This great opportunity requires you to have superb verbal and written skills. 

 

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