Council of State and Territorial Epidemiologists
Sr Director - Clinical Trials, Clinical Development
Council of State and Territorial Epidemiologists, Boston, Massachusetts, us, 02298
Foundation Medicine, Inc.
Full Time
Sr Director, Clinical Trials, Clinical Development About the Job The Sr Director, Clinical Trials, Clinical Development is a highly visible and cross-functional leadership role on the Foundation Medicine Clinical Development team, partnering closely with various teams across the company. This position leads the clinical evidence strategy, planning and execution of scientific collaborations or clinical trials with key opinion leaders and leverages prospective and real‑world clinical datasets with the goal of driving evidence activities to support the product development throughout the life cycle management, establishing the clinical validity and utility of genomic profiling, ensuring alignment with overall business goals.
Key Responsibilities
Accountable and lead of the development of Clinical Development Plans (CDP) for diagnostic assays, including clinical validation and utility studies supporting the analytical validity of the product as well as post‑launch data.
Lead of the development and execution of other Department initiatives and /or Evidence Generation Working Groups.
Working closely with Product, R&D, Commercial, Biopharma, Payers, Medical Affairs, and other functions to ensure alignment and successful product development throughout the life cycle management.
Demonstrate Medical leadership, including on Department initiatives, Business teams, Working groups and Product strategy. Can conceptualize/identify projects and prioritize in the context of Foundation Medicine business interests, ensuring studies advance the strategic priorities of Foundation Medicine portfolio.
Apply extensive theoretical and cross‑functional expertise, including outside of own discipline, in the context of company objectives to independently address complex problems with regular use of ingenuity and innovation.
Partner with scientists to guide and support the planning and delivery of impactful evidence generation activities.
Oversee the design, execution and monitoring clinical trials leveraging innovative diagnostic applications.
Conduct translational research to develop insights into predictive and prognostic biomarkers.
Leverage Foundation Medicine's clinical and genomic datasets to link genomic findings with clinical outcomes.
Collaborate cross‑functionally to identify and prioritize key clinical studies that support use, access, and reimbursement.
Manage and establish beneficial and new collaborations with key opinion leaders and external collaborators.
Serve as a subject matter expert on clinical aspects and molecular diagnostics. Continually develop deep domain expertise in genomics from a scientific, clinical and technical standpoint and lend insights to cross‑functional teams to further the development of our products and strategy.
Maintain availability to the wider Foundation Medicine business for clinical development expertise, presenting information to scientific, medical, or nonprofessional stakeholders.
Other duties pertaining to clinical / translational science as assigned.
Qualifications Basic Qualifications
M.D. or Ph.D. with 12+ years of industry experience or equivalent in oncology or hematology field or
Master's degree in related field and 15+ years of work experience
Preferred Qualifications
Prior experience in planning and executing clinical trials for biomarker‑driven cancer therapies and/or immuno‑oncology trials
Experience with clinical study design and clinical protocol drafting
Demonstrated experience in the field of genomics
Demonstrated experience in drug development
Experience with biomedical data analysis (genomics data, clinical outcomes, blood biomarkers i.e. circulating tumor DNA)
Demonstrated ability to lead cross‑functional teams, collaborate effectively and communicate clearly with various stakeholders
Experience communicating with treating physicians
Demonstrated ability to successfully manage multiple concurrent projects in a fast‑paced, dynamic environment
Strong track record of taking projects from concept to completion
Demonstrated excellence in scientific writing
Ability to work independently as well as collaborate and communicate effectively with cross‑functional teams
Strong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, and problem solving with other departments and colleagues
Excellent organizational skills and meticulous attention to detail
Extremely high level of integrity and reliability
Willingness to adhere to all applicable Foundation Medicine Standard Operating Procedures, policies, processes, and compliance guidelines
Agreement to maintain confidentiality regarding sensitive company, employee, and proprietary data and information
Commitment to reflect Foundation Medicine's values: Integrity, Courage, and Passion
The expected salary range for this position based on the primary location of Boston, MA is $275,000 - $327,000 per year. The salary range is commensurate with Foundation Medicine's compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.
Hybrid
Equal Opportunity Statement Foundation Medicine is proud to be an Equal Opportunity and Affluent Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. The EEO Statement, Supplement, and other EEO resources are available. If you have a disability or special need that requires accommodation, please let us know by completing this form. (EOE/AAP Employer)
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Sr Director, Clinical Trials, Clinical Development About the Job The Sr Director, Clinical Trials, Clinical Development is a highly visible and cross-functional leadership role on the Foundation Medicine Clinical Development team, partnering closely with various teams across the company. This position leads the clinical evidence strategy, planning and execution of scientific collaborations or clinical trials with key opinion leaders and leverages prospective and real‑world clinical datasets with the goal of driving evidence activities to support the product development throughout the life cycle management, establishing the clinical validity and utility of genomic profiling, ensuring alignment with overall business goals.
Key Responsibilities
Accountable and lead of the development of Clinical Development Plans (CDP) for diagnostic assays, including clinical validation and utility studies supporting the analytical validity of the product as well as post‑launch data.
Lead of the development and execution of other Department initiatives and /or Evidence Generation Working Groups.
Working closely with Product, R&D, Commercial, Biopharma, Payers, Medical Affairs, and other functions to ensure alignment and successful product development throughout the life cycle management.
Demonstrate Medical leadership, including on Department initiatives, Business teams, Working groups and Product strategy. Can conceptualize/identify projects and prioritize in the context of Foundation Medicine business interests, ensuring studies advance the strategic priorities of Foundation Medicine portfolio.
Apply extensive theoretical and cross‑functional expertise, including outside of own discipline, in the context of company objectives to independently address complex problems with regular use of ingenuity and innovation.
Partner with scientists to guide and support the planning and delivery of impactful evidence generation activities.
Oversee the design, execution and monitoring clinical trials leveraging innovative diagnostic applications.
Conduct translational research to develop insights into predictive and prognostic biomarkers.
Leverage Foundation Medicine's clinical and genomic datasets to link genomic findings with clinical outcomes.
Collaborate cross‑functionally to identify and prioritize key clinical studies that support use, access, and reimbursement.
Manage and establish beneficial and new collaborations with key opinion leaders and external collaborators.
Serve as a subject matter expert on clinical aspects and molecular diagnostics. Continually develop deep domain expertise in genomics from a scientific, clinical and technical standpoint and lend insights to cross‑functional teams to further the development of our products and strategy.
Maintain availability to the wider Foundation Medicine business for clinical development expertise, presenting information to scientific, medical, or nonprofessional stakeholders.
Other duties pertaining to clinical / translational science as assigned.
Qualifications Basic Qualifications
M.D. or Ph.D. with 12+ years of industry experience or equivalent in oncology or hematology field or
Master's degree in related field and 15+ years of work experience
Preferred Qualifications
Prior experience in planning and executing clinical trials for biomarker‑driven cancer therapies and/or immuno‑oncology trials
Experience with clinical study design and clinical protocol drafting
Demonstrated experience in the field of genomics
Demonstrated experience in drug development
Experience with biomedical data analysis (genomics data, clinical outcomes, blood biomarkers i.e. circulating tumor DNA)
Demonstrated ability to lead cross‑functional teams, collaborate effectively and communicate clearly with various stakeholders
Experience communicating with treating physicians
Demonstrated ability to successfully manage multiple concurrent projects in a fast‑paced, dynamic environment
Strong track record of taking projects from concept to completion
Demonstrated excellence in scientific writing
Ability to work independently as well as collaborate and communicate effectively with cross‑functional teams
Strong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, and problem solving with other departments and colleagues
Excellent organizational skills and meticulous attention to detail
Extremely high level of integrity and reliability
Willingness to adhere to all applicable Foundation Medicine Standard Operating Procedures, policies, processes, and compliance guidelines
Agreement to maintain confidentiality regarding sensitive company, employee, and proprietary data and information
Commitment to reflect Foundation Medicine's values: Integrity, Courage, and Passion
The expected salary range for this position based on the primary location of Boston, MA is $275,000 - $327,000 per year. The salary range is commensurate with Foundation Medicine's compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.
Hybrid
Equal Opportunity Statement Foundation Medicine is proud to be an Equal Opportunity and Affluent Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. The EEO Statement, Supplement, and other EEO resources are available. If you have a disability or special need that requires accommodation, please let us know by completing this form. (EOE/AAP Employer)
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