Senior Director, Oncology Clinical Research

A leader in the discovery and development of innovative medicines that utilize next generation antibody-based technologies requires a Senior Director, Oncology Clinical Research.

The Senior Director, Oncology Clinical Research provides medical input to all aspects of product development, for new and innovative treatments being developed in patients. This individual serves as scientific and medical member for clinical team(s) working closely with clinical project lead, the regulatory lead, and the operational lead(s) for overall programs within the therapeutic area. This individual develops clinical study concepts based on thorough scientific review and consultation with internal and external experts as well as senior scientists and acts as author/developer of clinical summary and other supporting documents for regulatory submissions and for publications.

Responsibilities and Job Duties:

• Provides medical guidance for the design of biomarker studies and provides a medical perspective to biomarker data interpretation.
• Responsible for medical components of the design, execution, and reporting of study protocols as well as (in collaboration with other team members) labeling and regulatory communications.
• Interacts closely with the pre-clinical team to understand the scientific basis of targeted therapy and the relationship to clinical practice decision-making.
• Collaborates with colleagues in clinical development and operations, research, bioPharma development and manufacturing, regulatory affairs, and product safety to participate in protocol development and the design of studies, statistical design, CRO selection and management, site monitoring, safety, clinical support of regulatory interaction, study reporting for new products that will ensure regulatory approval and commercial success.
• Directly develops or guides development of scientific/medical portions of clinical study reports, safety reports, and regulatory submissions to assure production of high-quality documents.
• Collaborates with clinical pharmacologist to interpret pharmacokinetic and toxicokinetic data and the implications for clinical study design.
• Ensures that study design is scientifically robust, suitable to test the trial's hypothesis, and likely to meet the objectives of the study while ensuring the safety of the patients participating in the Company’s sponsored clinical trials.
• Directs protocol implementation, including site identification, through communication with site investigators and their staff. Leads site initiation meetings and follow-up meetings with investigators.

Qualifications

• M.D., or D.O. with subspecialty and board eligibility/certification in oncology
• Significant experience in Oncology drug development may substitute for oncology specialization

Experience

• Clinical development experience in the pharmaceutical/biotechnology industry or academic medical setting
• Possesses early phase clinical development experience
• Minimum of 3 years of successful clinical research and/or drug development experience in biologics

The company will offer a competitive salary and bonus schedule together with an attractive stock package. For more information please forward a resume or otherwise get in touch at [email protected]