Location: Great Lakes Region
Contact: Jackie Bandish, firstname.lastname@example.org
Clinical Development Director | Diagnostic Company
We have been retained by our client to hire a Clinical Development Director. Our client has identified a gap and expertise and needs a clinician to help develop high level strategic clinical development plans for products from conception through reimbursement and post market needs. They have successful achieved a marketed product and have a full pipeline. The goal is to develop strategies on clinical evidence development. This is not about executing a protocol but about setting the strategy and being able to know what goes into the protocol, know how it is structured to assure that patient enrollment will work and that they can access the patients in a reasonable time-frame during the care of their journey.
ADDITIONAL INFORMATION ABOUT THIS COMPANY AND ROLE:
This is an opportunity to make the position your own, define what is needed with the organization and have the autonomy and support to build it out.
It is vital to bring forth a strong drug development background. Our client is focused in and has a pipeline in oncology.
Our oncology client’s mission is to get in front of the cancer with early detection.
The position will report in to the VP Clinical and Regulatory Affairs who oversees a combined team of 40 collaborative members.
HIGHLIGHTS OF RESPONSIBILITIES:
Develop clinical evidence strategy, create clinical development plans, conceptualize and author clinical protocols.
Collaborate with KOLs, biostatisticians, and outside consultants to provide clinical science inputs into clinical plans.
Write abstracts, manuscripts, and clinical study reports.
Provide support in preparation for scientific meetings (for example, advisory boards, consultant meetings and investigator meetings), regulatory submissions, and labelling documents.
Coordinate review of clinical study data, including gathering, analyzing, reviewing, and interpreting data. Provide preliminary assessments and recommendations.
DESIRED SKILLS AND QUALIFICATIONS:
A PhD, PharmD, or MD degree in a life science or health science related field.
At least 6 years of experience in medical device/IVD, biotech or pharmaceutical industry experience in preferable with clinical development or clinical research.
Experience or research in oncology, molecular biology, biochemistry, or related field.
A comprehensive understanding of the medical device development process and testing standards for IVDs.
Jackie Bandish, Head of Life Sciences Recruiting & Operations
Phone: 267-483-5233 x 104
The Bandish Group, LLC
Life Sciences Executive Search
1432 Easton Road, Suite 2B
Warrington, PA 18976