Leading and coordinating study activities in the assigned program/indication in collaboration with the Clinical Project Managers (CPM)
Contribution to the development of the Clinical Strategy/Clinical Development Plan in collaboration with Senior/Executive Medical director and Head of Clinical development and provide medical oversight into protocol development, study conduct and data generation, as well as reporting for the assigned program.
Oversee assigned program as medical monitor to ensure that regulatory requirements and quality standards are met. Strive to maintain or exceed compliance obligations for Good Clinical Practices guidelines and standard company operating procedures.
Support Senior/Executive Medical director and Head of Clinical Development as a company representative interacting with external scientific leaders and regulatory authorities for assigned program(s).
Reviewing and writing abstracts or manuscripts for publications and presentation
Co-leading investigator meetings and advisory committee meetings
Lead strategic reviews and input into documents (such as protocols, CRFs, Statistical Analysis Plans, CSRs) to ensure scientific/medical accuracy and consistency with clinical development program.
Integrate preclinical information (pharmacology, toxicology, pharmacokinetics) and interpret implications for clinical development as articulated in the Investigator’s Brochure and first-in-human protocol.
Co-lead product safety review committees as appropriate.
Provide consultation on medical subjects to investigators and other company personnel, and apply medical knowledge to guide the safe, ethical, and efficient conduct of trials.
Participate in due diligence efforts for clinical partnerships and in-licensing opportunities
Work with specific clinical and research partners to facilitate seamless execution of collaborative efforts.
Degree as Doctor of Medicine or equivalent
Board-certification (or local equivalent) in oncology/hematology. Demonstrated potential or ability to design, initiate, and conduct clinical studies.
Proven experience as medical monitor in academia, industry or CRO, experience in either early stage or late stage oncology clinical trials or required
Proven ability to analyze and interpret efficacy and safety data relating to oncology.
Able to work across many interfaces (clinical/clinical operations, clinical/project management, clinical/regulatory, clinical/commercial, etc.).
Demonstrated strong interpersonal skills, ability to influence, and the ability to function in a global team environment.
Strong and effective communication skills (written and verbal), with excellent medical/scientific writing skills.
Excellent personal ethical integrity and a commitment to improving the outcomes for patients.