Internal Application: Medical Director
Clinical Development | San Francisco, Ca | Full Time
Overview of the Role
The Medical Director is responsible contributing to the design, conduct and execution of clinical trials and ultimately to ensure the safety of the clinical trial subjects and clinical integrity of the trial subject. In addition to study level activities, the Medical Director will participate in defining and shaping the overall clinical trials strategy across the institute.
As a recognized clinical expert in cancer immunotherapy, the Medical Director applies comprehensive knowledge of the field to inform clinical research protocols and processes to ensure that participant safety is paramount in the study design. Working within a matrix environment, the Medical Director works closely with functional groups to ensure that protocol development and implementation follow the safety monitoring plan.
Reporting Structure and Team
The Medical Director will report to the VP for Clinical Research and Development and will be a key member of the Clinical Research and Development team.
- Provide medical oversight regarding protocol design, execution and general medical-related study issues
- Review laboratory alerts, and coordinate appropriate follow-up with study site
- Conduct a medical review of the SAP, Project Plan, Tables and Listings, and the
Integrated Clinical Study Reports as appropriate
- Conduct training for the project team concerning the disease, drug, study design and
- Provide consultation to the study team during review of out-of-range laboratory values
for clinical and /or protocol significance
- Preview listings, lab reports, and subject profiles as defined within the Safety Medical
Monitoring Plan and the medical monitoring plan
- Ensure all protocol inquires and answers are documented
- Ensure the study is in a continuous state of inspection readiness
- Additional tasks may involve attendance and participation at Investigator Meetings,
preparation of subject narratives, review of study reports and other documents,
preparation and/or review of periodic and interim safety reports
- Play a key role in the interaction with regulatory authorities
- Accountable for managing, training and overseeing the activities of CRO medical monitors
- Work directly with center directors and co-directors to identify areas of unmet medical need, and novel combinations of interest.
- Discuss emerging data from PICI members and assess novel combinations
- Review available preclinical data that could inform the design of future clinical trials
- Work with partners such as other non-profit organizations, academic centers and industry to identify projects of mutual interests
Required Professional Experience
- MD and Medical Oncology training (Completion of Oncology fellowship (Board eligible/certified))
- Experience in Immuno-Oncology and awareness of the recent development in the field
- Experience in novel: novel combinations and innovative designs for early phase studies
- Clinical Development Expertise - demonstrated understanding of the required steps to progress a new biologic through the stages necessary to allow it to be tested in human clinical trials. Ability to ensure high quality in the design, development, execution, statistical analysis, clinical interpretation and reporting of clinical studies.
- Good Clinical Practice Certification - ensure an investigation is conducted according to Good Clinical Practice regulations and internal control documents, in order to protect the rights, safety, and well-being of subjects and the accuracy and validity of the trial data.
- A proven track record of effectively applying medical expertise to make good clinical decisions, in accordance with appropriate SOP(s).
- Scientific & Medical Knowledge – Demonstrated current and in-depth understanding of the state of cancer immunotherapy
- Clinical Data Stewardship – demonstrated understanding of the critical importance of rigorous data generation and disciplined stewardship of the data
- Medical Monitoring / Pharmacovigilance - demonstrated understanding of the detection, investigation, assessment and prevention of adverse effects of medicines on patients. Understanding of when to involve the VP for Clinical Research and Development for escalation.
- Scientific Writing - ability to produce written scientific communications with clarity, accuracy and rigor and in compliance with PICI control documents governing disclosure, publication and principles of scientific exchange
- Scientific Presentation - ability to communicate effectively through formal presentation and through informal scientific discussion with credibility, accuracy, and confidence with internal and external stakeholders and experts