Fate Therapeutics
Director, Clinical Science, Autoimmunity
Fate Therapeutics, San Diego, California, United States, 92189
Fate Therapeutics is looking for a Director, Clinical Science to join the Clinical Development team. This key contributor will lead Clinical Science activities for the Company's autoimmune programs, including the development of clinical strategic documents and regulatory documents. The ideal candidate will have 10+ years of relevant and progressive work experience in planning, executing, reporting, and publishing clinical studies in a biotech, pharmaceutical, and/or CRO environment. This is a full-time, exempt position located at our corporate headquarters in San Diego, CA.
Responsibilities
Work with Medical Director(s) to create key strategic documents including clinical development plans, clinical protocols and synopses for assigned product(s), amendments, and other study-related documents for Autoimmunity programs.Work closely with Clinical Operations to execute the clinical trial efficiently, with high quality, and within timelines.Contribute to the development of clinical sections of regulatory documents including Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, informed consents, eCRFs, statistical analysis plans, regulatory approval submissions, serious and non-serious adverse event evaluation, and supporting responses to Health Authorities questions.Perform ongoing review, analysis, and interpretation of clinical data from individual studies, and translate study level clinical data across the program of studies for assigned compounds, ensuring that all studies are conducted with the highest level of ethical and safety standards and are in compliance with GCP and all regulatory policies.Maintain familiarity with standards of practice in the relevant therapeutic areas to contribute to strategic discussion and decision-making for the program.Contribute to data activities including query generation/resolution, data cleaning, and database locking.Provide internal safety monitoring for clinical trials in collaboration with the Study Medical Director and Drug Safety team.Develop effective working relationships with investigators to optimize scientific quality/innovation of clinical study design, execution, reporting, and publication.Contribute to trial-related advisory boards, investigators meetings, DMC, and protocol training meetings.Coordinate the real-time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic, and biomarker data, to provide consolidated information for Senior Management.Assist in forecasting trial resource needs (internal and external).May participate as a standing member of multidiscipline Project Teams.Qualifications
MD, MS, RN, PhD, or PharmD with a minimum of 10 years of relevant and progressive work experience in planning, executing, reporting, and publishing clinical studies in a biotech, pharmaceutical, or CRO environment.5+ years of experience in the design and conduct of autoimmune clinical trials.Experience in novel combinations and innovative designs for early phase studies.Proven experience writing scientific communications with clarity, accuracy, and rigor.Experience with U.S. and European regulatory authorities and submissions is desirable.Experience or exposure to the development of cell therapies is desirable.Self-motivation, good judgment, strong follow-up, organizational, analytical, and problem-solving skills; capable of identifying risks; creative and innovative thinker.Ability to work with, lead, and motivate a cross-functional matrix team.Excellent written and oral communication skills. Ability to communicate effectively through formal presentation and through informal scientific discussion with credibility, accuracy, and confidence with internal and external stakeholders and experts.Working conditions & physical requirements
Travel may be required.Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.Compensation
The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.The anticipated salary range for this role is $220,000 - $240,000.The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.Equal Employment OpportunityFate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.
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Responsibilities
Work with Medical Director(s) to create key strategic documents including clinical development plans, clinical protocols and synopses for assigned product(s), amendments, and other study-related documents for Autoimmunity programs.Work closely with Clinical Operations to execute the clinical trial efficiently, with high quality, and within timelines.Contribute to the development of clinical sections of regulatory documents including Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, informed consents, eCRFs, statistical analysis plans, regulatory approval submissions, serious and non-serious adverse event evaluation, and supporting responses to Health Authorities questions.Perform ongoing review, analysis, and interpretation of clinical data from individual studies, and translate study level clinical data across the program of studies for assigned compounds, ensuring that all studies are conducted with the highest level of ethical and safety standards and are in compliance with GCP and all regulatory policies.Maintain familiarity with standards of practice in the relevant therapeutic areas to contribute to strategic discussion and decision-making for the program.Contribute to data activities including query generation/resolution, data cleaning, and database locking.Provide internal safety monitoring for clinical trials in collaboration with the Study Medical Director and Drug Safety team.Develop effective working relationships with investigators to optimize scientific quality/innovation of clinical study design, execution, reporting, and publication.Contribute to trial-related advisory boards, investigators meetings, DMC, and protocol training meetings.Coordinate the real-time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic, and biomarker data, to provide consolidated information for Senior Management.Assist in forecasting trial resource needs (internal and external).May participate as a standing member of multidiscipline Project Teams.Qualifications
MD, MS, RN, PhD, or PharmD with a minimum of 10 years of relevant and progressive work experience in planning, executing, reporting, and publishing clinical studies in a biotech, pharmaceutical, or CRO environment.5+ years of experience in the design and conduct of autoimmune clinical trials.Experience in novel combinations and innovative designs for early phase studies.Proven experience writing scientific communications with clarity, accuracy, and rigor.Experience with U.S. and European regulatory authorities and submissions is desirable.Experience or exposure to the development of cell therapies is desirable.Self-motivation, good judgment, strong follow-up, organizational, analytical, and problem-solving skills; capable of identifying risks; creative and innovative thinker.Ability to work with, lead, and motivate a cross-functional matrix team.Excellent written and oral communication skills. Ability to communicate effectively through formal presentation and through informal scientific discussion with credibility, accuracy, and confidence with internal and external stakeholders and experts.Working conditions & physical requirements
Travel may be required.Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.Compensation
The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.The anticipated salary range for this role is $220,000 - $240,000.The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.Equal Employment OpportunityFate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.
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