Pharma-Cruiting Life Sciences Executive Search is seeking a Director / Senior Director, Clinical Development & Medical Affairs for an oncology diagnostic company in the Mid-West.
The incumbent will be responsible for the design, implementation, and execution of a Clinical Development & Medical Affairs program for specific indications for a new technology that serves as an aid in the diagnosis of cancer.
Major Responsibilities will include:
• Strategic planning for assay development in a specific indication (e.g., Breast or Lung Cancer)
• Design and conduct of clinical studies for assay validation
• Preparation and review of written documents: Clinical Study Protocols, Case Report Form, Clinical Study Reports
• Interactions with key individuals on the assay Development Portfolio Management Team
• Preparation of documents for submission to regulatory authorities (e.g., Meeting Packages, Pre-Market Approval application, & clinical components of other regulatory correspondence)
• Participation as clinical expert in the evaluation of early discovery biomarkers or early stage external assets for their potential to be successfully candidates for new assay development
• Clinical oversight and direction of post-marketing studies
Essential Functions:
• Ongoing thorough and up-to-date knowledge of therapeutic areas of assets for development, including trends and competitive clinical landscape
• Close collaboration with Discovery Research, Statistics & Bioinformatics, and other disciplines within the company
• Interaction with Medical Affairs, Discovery research, and the Commercial group to achieve optimal target product profile for diagnostic assays in development and to achieve optimal commercialization of approved diagnostic assays
Minimum education requirements MD:
• Experience required 10+ Years
• Knowledge & skills (general and technical)
• Background in clinical research including, ideally to include randomized clinical trials, observational studies, & diagnostic assay validation studies
• Prior experience in clinical study design in industry or a focus on clinical research in academic medicine is desirable
• Knowledge of FDA regulations regarding evaluation and approval of new technology with an understanding of evolving requirements for new diagnostic assays
Other requirements (licenses, certifications, specialized training, physical or mental abilities required):
• MD or DO from an accredited Medical School
• Prefer: US Board Certification in Internal Medicine; Internal Subspecialty Training & Certification a plus in areas such as Pulmonary Medicine, Gastroenterology or similar
To apply: Please email ruth@pharmacruiting.com
