Foundation Medicine · 22 hours ago
Sr. Director - Clinical Trials, Clinical Development
Boston, MA
Full-time
Hybrid
Director/Executive
$275K/yr - $327K/yr
12+ years expFoundation Medicine is a leading company in the field of genomic profiling and clinical development. The Sr. Director of Clinical Trials will lead the clinical evidence strategy and execution of scientific collaborations, ensuring alignment with business goals and overseeing the development of clinical development plans for diagnostic assays.
BiotechnologyGeneticsHealth CareMedical
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 closing 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
Overseeing 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
Serving 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 pertinent to clinical / translational science as assigned
Qualification
Required
M.D. or Ph.D. with 12+ years of industry experience or equivalent in oncology or hematology field
Master's degree in related field and 15+ years of work experience
Preferred
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
Benefits
A discretionary annual bonus may be available based on individual and Company performance.
This position also qualifies for Foundation Medicine's benefits.
Company
Foundation Medicine
Foundation medicine is a molecular information company developing clinical diagnostic tests that facilitates personalized cancer therapies.
1001-5000 employees
H1B Sponsorship
Foundation Medicine has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (26)
2024 (41)
2023 (30)
2022 (36)
2021 (41)
2020 (45)
Funding
Current Stage
Public CompanyTotal Funding
$96.5MKey Investors
Kleiner Perkins
2015-01-12Acquired
2013-09-25IPO
2013-01-08Series B· $13.5M
Leadership Team
Daniel Malarek
Chief Executive Officer
David Fabrizio
VP, Commercial Strategy and Medical Innovation
Recent News
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