Quality Recruiting. Established Experts.
Medical Director Oncology Translational Medicine
Reference Number: 2862
Location: Northeast
Our client is a major global healthcare company. They have asked us to assist them in their search for a Medical Director Oncology Translational Medicine.
The company’s Translational Clinical Oncology (TCO) team is seeking a Medical Director Oncology Translational Medicine to provide strategic medical guidance for and to lead the development of experimental oncology agents in the TCO portfolio, beginning with the candidate selection phase (CSP) of preclinical development and continuing through clinical proof-of-concept (PoC).
Major tasks and responsibilities will include:
- Provides strategic medical guidance for the development of new oncology agents (both small molecules and biologics) that are in preclinical development, typically beginning at the candidate selection phase (CSP).
- Specifically responsible for creating a clinical development strategy for new oncology agents that are within the CSP to PoC timeframe. The development strategy combines the incumbent’s medical knowledge with the expertise of colleagues in a wide range of other disciplines (e.g., Clinical Pharmacology, Biostatistics) to optimize the clinical development strategy.
- Provides an early clinical development strategy that foresees and supports subsequent registration trials.
- Acts as the leader for Early Program Teams (EPTs), beginning at the time of sPOC approval (approval to conduct GLP toxicology studies to enable the start of clinical development) and continuing through those clinical trials needed to demonstrate PoC.
- Integrates preclinical information (pharmacology, toxicology, pharmacokinetics) and interprets its implications for clinical development, as articulated in the Investigator’s Brochure and first-in-human protocol.
- Collaborates with clinical scientists to develop clinical protocols for TCO compounds and to develop the instruments needed to implement, interpret and report them (e.g., case report forms, report and analysis plans, clinical study reports).
- Applies his or her medical knowledge to guide the safe, ethical and efficient conduct of the trials under his or her responsibility.
- Liaises with outside experts, investigators, and regulatory authorities in the field of oncology, and represents his or her projects to those groups and authorities.
- Writes and reviews abstracts/manuscripts, etc. for presentation/publications at internal/external meetings.
- Participates in task forces to support continuous improvement and other management objectives.
We seek candidates with the following qualifications:
- MD or DO degree required. Board-certification in an oncology specialty is preferred.
- 3-5 years of pharma/biotech industry experience in oncology clinical trials and the equivalent term of experience in the academic setting In case of no industry experience, substantially longer academic experience in translational oncology and substantial clinical study experience.
- Must have facility with the interpretation of preclinical data in oncology (molecular biology, pharmacology, pharmacokinetics, and toxicology).
- Working knowledge of the application of PK/PD and biostatistics to clinical development and clinical trials.
- Proven ability to analyze and interpret efficacy and safety data relating to oncology.
- Knowledge of GCP and world-wide regulatory requirements relating to clinical trials and oncology.
- Excellent medical/scientific writing skills.
- Effective written and oral communication skills.
- Proven ability to manage and develop a team.
- Excellent personal ethical integrity and a commitment to improving the outcomes for patients with malignancies.
Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2862. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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Dear Jan, I cannot thank you enough for all the help and support you gave throughout the selection process, and most recently the hiring and relocation process with [name of company]. I have enjoyed working with you and am very grateful to you. I am extremely excited to start next week!
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