Title: Associate Medical Director/Medical Director
Location: Menlo Park, CA
Forty Seven Inc. is committed to helping patients defeat their cancer. We are advancing immuno-oncology through the engagement of new and complementary phagocytic pathways that enhance anti-tumor efficacy and selectivity.
Forty Seven, Inc. is a clinical-stage biotech company that is pioneering breakthrough solutions to advance the next generation of immuno-oncology treatments for hematological malignancies and solid tumors. We are seeking an Associate Medical Director/Medical Director that will be responsible for providing clinical leadership in the definition of clinical development strategies, as well as the design, execution, and analysis of clinical studies conducted with Forty Seven’s academic, community and industry partners. This individual should be passionate about oncology drug development and working in an innovative therapeutic field. This individual should also have expertise and clinical experience in the management of hematological malignancies. This position reports to the Vice President, Clinical Development.
These may include, but are not limited to, the following; other duties may be assigned
- Leads and participates in cross-functional hematology and oncology drug development matrix teams Lead the formulation of clinical development plans, including selection of proof of concept indications and pivotal registrational trials in selected indications
- In collaboration with multidisciplinary team members, be responsible for the design of protocols and conduct of data review, analysis, and interpretation
- Functions in the role of medical monitor, providing medical oversight of multiple clinical studies and guidance on scientific, clinical and safety monitoring issues.
- Listed below are some of the key responsibilities required for effective medical monitoring:
- Review and approve all versions of the patient information leaflet and informed consent form templates
- Participate in the draft, review and ownership of study-specific medical monitoring plans (MMP)
- Review study statistical analysis plans
- Provide appropriate clinical training for internal and external study team members and site personnel as and when required before and during conduct of studies.
- Review serious adverse events (SAEs) that occur during studies as and when they are notified to Drug Safety to assist in identifying any emergent safety concerns that may be related to study conduct.
- Review safety information including adverse events and clinical laboratory data during study conduct.
- Review the outputs of safety signal detection analysis and recommend appropriate remedial action as and when deemed necessary to ensure the protection of subject safety.
- Support the CTSC (clinical trial steering committee) as and when such a Committee is constituted for a study.
- Review draft data listings, provided by Data Management to ensure medical consistency of the data.
- Participate in the review and interpretation of study data and in the overall review and approval of final study reports.
- Properly document all medical monitoring activities and communications related to allocated studies.
- Primary clinical author of regulatory documents including (IB, DSUR, annual reports, IND sections, CSR)
- Interface with US/international regulatory authorities, as appropriate, in of the development objectives and assist in the compilation of submissions and responses to inquires
- Leads/participates in clinical and translational data review and analysis and makes appropriate recommendations based on these data
- Serves as a medical and scientific expert to drug discovery teams and contributes to selection of discovery compounds, development of clinical strategy and transition of compounds into early phase development
- Builds relationships with thought leaders and principal investigators for input on disease areas in oncology and design of clinical programs and is comfortable interacting on a peer-to-peer basis with key opinion leaders
- Serves as one of the company's scientific and medical experts at advisory boards and public forums
Education & Experience:
- MD required, board eligible or certified in hematology/oncology, with strong scientific background
- Exceptional candidates with hematology/ oncology experience who are not MDs will be considered
- MD, PhD preferred
- Experience or training in the treatment of hematological malignancies is essential; experience in bone marrow transplantation is a plus
- 2+ years of hands on pharmaceutical/biotechnology industry experience in oncology clinical development preferred but not required
- Candidates transitioning from academic training with clinical trials and/or translational research experience in oncology will be considered
- Translational or clinical trials experience in immuno-oncology is a plus
- In depth knowledge of the drug development process and oversight of clinical trials
- Working knowledge of biostatistics, regulatory, clinical pharmacology, pharmacokinetics and pharmacodynamics
- Experience in filing US INDs and/or BLA/NDAs is a plus
- Ability to manage multiple tasks and prioritization skills, work in a collaborative matrixed team environment
- Ability to critically analyze scientific and clinical data and literature
- Strong background in basic or translational research is a plus
- Excellent interpersonal and communication skills (written and verbal)
- Passionate about oncology drug development and working in an innovative therapeutic field
Position may require occasional travel (~15-20%), domestic and international.