Medical Director, Oncology
Our client is a biotechnology company. They have asked us to assist them in a search for a Medical Director, Oncology.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Provides strategic input to the translational medicine and drug discovery teams.
- Provides clinical and scientific input into discovery research and early development activities including disease education, target identification, lead selection, preclinical pharmacology, nonclinical toxicology, biomarker strategy and IND enabling studies, to develop optimal approaches to facilitate development.
- Contributes to the development of robust product development plans for each program, including providing content for clinical development and other sections as needed.
- Identifies and establishes relationships with leading KOLs and principal investigators, including organizing and running KOL investigator meetings as needed.
- Serves as medical monitor for organization sponsored clinical trials.
- Contributes to the development of regulatory strategy and provides medical expertise in meetings with regulatory bodies.
- Serves as a consultant for the organization’s technology partners for their early development plans and clinical trials for ADCs.
- An MD is required, an MD/PhD is preferred.
- Must have at least 5 years of experience in clinical development of novel oncology therapeutics, or an equivalent time in oncology clinical practice. Experience with antibody-drug conjugates is preferred.
- Experience interacting with and managing external resources (CROs) is required.
- Required experience representing function to global regulatory agencies in support of submissions at all stages of development, i.e., IND/CTA, CTD, IMPD, MAA/NDA/BLA/NDA.
- Knowledge of global regulatory requirements and expectations for packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable global guidelines is desired.
- Must have a record of success working in cross-functional teams.
- Requires the ability to lead by influence and have a positive impact inside and outside of the organization.
- Excellent oral and written communication skills are required.
- Must have the ability to travel as needed.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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