Five Prime Therapeutics, Inc. is a biopharmaceutical company focused on discovering and developing transformative protein-based medicines for patients with serious unmet medical needs. The company has an emerging portfolio of innovative products for inflammation and cancer including:
FivePrime’s discovery platforms can rapidly interrogate the entire extracellular proteome in medically relevant in vitro and in vivo models leading to novel targets and drug leads. Our technology has been validated by our growing pipeline and through multiple partnerships with pharmaceutical companies including Johnson & Johnson, Pfizer, GlaxoSmithKline, and UCB across a range of therapeutic indications. FivePrime is committed to innovation and outstanding science, values which are reflected in our people and our products.
- FP-1039 – An FGF ligand trap in Phase Ib for solid tumors
- FPA008 – a monoclonal antibody in Phase I targeting CSF1R for inflammatory diseases
- FPA144 – a monoclonal antibody targeting FGFR2b for selected gastric cancers
- Potential immune checkpoint regulators for cancer immunotherapy
Reporting to either the Chief Medical Officer or the Senior Medical Director, depending on level of hire, the position is responsible for working collaboratively with members of the development team in establishing the clinical development strategy for one or more compounds anywhere from the pre-IND setting to pivotal trials and registration. The position is accountable for medical monitoring and patient safety and to provide medical guidance during the design, execution, and reporting of clinical studies.
The candidate will work within the project team structure, sitting on core project teams to guide strategy, and working within relevant sub-teams to ensure tactical alignment and execution.
The optimal candidate will demonstrate leadership qualities with significant knowledge and experience in developing Phase 1 & 2 protocols, analyzing pharmacokinetics, safety and efficacy data and advancing pharmaceutical large molecules (biologics) through preclinical, clinical stages, BLA/NDA submissions, and Advisory/Scientific Committee Meetings. The candidate will have authored relevant sections of regulatory submissions for INDs, CTAs and global filings and, ideally, will have an established a track record of publishing articles and abstracts in professional journals.
- Apply subject matter expertise towards formulation of clinical development plans, including selection of the proof of concept indication.
- In collaboration with appropriate team members (e.g., clinical pharmacology, statistics, translational medicine), is responsible for the design and authorship of study protocols and interpretation of clinical study data.
- Conduct medical monitoring and data listing reviews
- Work closely with Clinical Operations colleagues on study implementation and oversight, which includes site and CRO selection and investigator meeting preparation.
- Accountable for safety across studies, including regular review of safety data (including but not limited to SAEs) and response to safety issues.
- In conjunction with Development colleagues, prepare strategy presentations, present and discuss data at relevant team, governance, external consultant, KOL, and regulatory meetings.
- Author clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR).
- Participate in preparation for and conduct of meetings with Healthcare Authorities
- Participate in the development and delivery of protocol training for investigator site and FPRX staff.
- Educate team members and vendors on the molecule and disease area and participating in internal continuing education activities
- Contribute to the clinical development plan for one or more compounds, including review of the pre-clinical package after soliciting appropriate input, review and endorsement from key stakeholders for go/no-go development decision criteria
- Assume the clinical leadership role for a project if required, representing the medical function on the project team and representing the team for medical discussions with the Development Committee
- As a member of the project team, interface with Statistics, PK/PD, Regulatory, Clinical Operations, Diagnostics, Translational Medicine, Project Team Leadership and Management and other members of the extended project team(s).
- In conjunction with the Clinical Operations, is responsible for the on-time and within-budget execution of protocols.
- May have functional responsibility for other clinicians or clinical scientists assigned to the project and may supervise and develop other colleagues.
- Organize and prepare for Advisory Board meetings
- Act as clinical representative for in-licensing activities such as due diligence reviews, reports, and development strategies.
BioSpace.com - 7 months ago