Fast growing, high profile Pharmaceutical company in Cambridge is expanding!!!
MUST BE STRONG COMMUNICATOR AND SELF STARTER WITH PRIOR CLINICAL DEVELOPMENT BACKGROUND
You would be 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 a new therapeutic areas. Forming close partnerships with clinical operations, you’ll 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’ll 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’ll 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’re the right fit?
With your comprehensive understanding of the drug development process in all phases of testing, you’ll enjoy contributing to the clinical strategy and creation of the clinical development plans while working as part of an integrated team. You’ll 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. You’ll also be someone who gets excited about data! You’ll love to make sure it’s 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 RN, MS, PhD or PharmD, or equivalent with clinical research experience and a strong knowledge of drug development. You’ll need at least 3 - 5 years of technical operational experience in planning, executing, 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.
Do not need Metabolic or GI (that is just a plus).
this is all in Clinical Development
There is a Snr Director, Clinical Operations and a Director, Clinical Operations
This role will report to Medical Director
They need a Snr CRS who is independent
Very dynamic group at company
HUGE growth phase
They are in a phase 3 study (and have two phase 1 studies with positive results so far)- company in expansion
This person MUST have exceptional communications skills
Excellent communicator to interact AND influence internal and external teams, vendors, doctors