Foresight Diagnostics Inc.
Director, Medical Affairs
Foresight Diagnostics Inc., Boulder, Colorado, United States, 80301
Director, Medical AffairsLocation: Boulder, CO/HybridAbout our Company:Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.
About the Role:The Director, Medical Affairs balances administrative and technical responsibilities, supporting corporate goals and initiatives, providing specialist medical/scientific strategic and operational leadership into medical affairs activities. The Director supports their team and interacts and collaborates with external partners, consultants, and regulatory agencies. They focus on planning, building, and executing clinical studies, from initial conception through execution, data analysis and interpretation, and publication. They will work with leading academic and biopharmaceutical partners, among others. They will ensure compliance with local and international regulations, Good Clinical Practices (GCPs), company standards, and the Principles of Medical Research and Development.
What you Will Bring:
Medical Doctorate (M.D.) degree (or equivalent D.O. or non-US equivalent of M.D), Advanced Degree PhD, or combination thereof with additional post doctorate experience preferred.
Minimum of 8 years relevant clinical, therapeutic, or scientific industry experience.
Minimum of 3 years people management experience.
Proven excellence in all aspects of Medical Affairs.
Expertise in clinical data analysis, including but not limited to clinical outcomes data, clinical trial data, prognostic and predictive biomarkers.
Expertise in data presentation, with an ability to synthesize complex data to create simple and clear conclusions.
Excellent oral and written communication skills.
Excellent planning, organizing, and project management skills.
Strong team leadership capabilities and a desire to interact with and respond to multidisciplinary and cross-cultural teams.
Ability to establish and manage relationships effectively.
Ability to establish and cultivate external partnerships in an effective and self-driven manner.
Exceptional interpersonal and communication skills to deal with all stakeholders.
Mature approach, with the ability to work independently and hands-on without constant supervision.
Strong analytical and strategic thinking skills.
Ability to write, speak, and present information persuasively.
Adherence to high ethical business principles and values.
High emotional intelligence.
High drive, determination, and a collaborative approach to work.
What You Will Do:
Ability to run a clinical program or medical affairs team(s) independently with little supervision.
Understand the current and evolving treatment landscape and pathways across all types of cancer.
Develop and cultivate partnerships outside the organization, including with academics and industry.
Guide and perform clinical analyses, in collaboration with bioinformatics and statistical team members.
Create and give data presentations and publications summarizing the key results of studies.
Understand the competitive landscape of cancer diagnostics, including identifying gaps, opportunities, and needs in the market.
Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in developmental strategy and the protocols.
Leads and partners on the development of multiple asset strategies within the pipeline and strategic governance frameworks.
Provide scientific and technical support for assigned products; deliver scientific presentations; develop and maintain professional and credible relationships with key opinion leaders; actively participate in relevant teams and help develop medical affairs strategies for assigned products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training.
Oversee scientific/medical education of investigators, clinical monitors, and team members.
Maintain knowledge currency of professional information and technology through conferences and/or medical literature.
Craft scientifically accurate materials, medical education programs, advisories, and symposia.
Ensure compliance with applicable organizational policies and procedures.
Clear understanding of regulatory requirements related to the clinical studies and compliance accountability.
Exercise sound judgment within broadly defined practices and policies for obtaining practical and efficient solutions.
Ensure alignment of clinical plans and global development plans.
Ensure commitments are met or exceeded.
Monitor clinical research plan implementation and take corrective action if progress is inadequate.
Monitor other deliverables (e.g., publications, field support) and take corrective action if needed.
Approve and implement local support in clinical research studies to meet business objectives.
Scientific and Technical Expertise
Deep scientific and technical expertise, balancing an understanding of clinical oncology and data analysis with roles in commercialization support with administrative activities.
Critical evaluation of medical literature and competitive product data.
Review proposals and publications.
Provide technical expertise and oversight.
Perform and guide clinical data analyses in support of publications and studies.
Scientific Data Dissemination and Exchange
Ensure timely dissemination of clinical trial data.
Support the critical analysis and dissemination of data through various formats (manuscripts, abstracts, posters, slide sets).
Perform and guide figure generation in support of external presentation and publication of studies.
Establish and maintain collaborations with external experts, thought leaders, and the medical community.
Support planning of symposia, advisory board meetings, and other professional meetings.
Oversee team attendance and scientific congress support.
Business/Customer Support
Ensure medical team compliance with standards for customer interactions.
Provide scientific support for marketing and sales activities.
Partner effectively with internal and external stakeholders.
Regulatory/Submission Responsibilities
Ensure clinical data for regulatory purposes meets required standards.
Participate in advisory committees as assigned.
Administrative Responsibilities
Career Development and Performance Management of direct reports.
Attend assigned meetings and contribute to management, processes, and policy development.
Participate in projects and committees as assigned.
Support plans, budgets, strategic planning, and staff recruiting efforts.
Ensure team members adhere to the highest medical ethical standards.
Implement new process improvement initiatives and best practices.
Act as a liaison with other functions and business units.
Compensation & Benefits:This role is offering a salary between $200,000-$320,000 and is eligible for equity offerings. Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.
The application deadline for this position is November 30, 2024.
You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Travel: Yes, 25% of the Time
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About the Role:The Director, Medical Affairs balances administrative and technical responsibilities, supporting corporate goals and initiatives, providing specialist medical/scientific strategic and operational leadership into medical affairs activities. The Director supports their team and interacts and collaborates with external partners, consultants, and regulatory agencies. They focus on planning, building, and executing clinical studies, from initial conception through execution, data analysis and interpretation, and publication. They will work with leading academic and biopharmaceutical partners, among others. They will ensure compliance with local and international regulations, Good Clinical Practices (GCPs), company standards, and the Principles of Medical Research and Development.
What you Will Bring:
Medical Doctorate (M.D.) degree (or equivalent D.O. or non-US equivalent of M.D), Advanced Degree PhD, or combination thereof with additional post doctorate experience preferred.
Minimum of 8 years relevant clinical, therapeutic, or scientific industry experience.
Minimum of 3 years people management experience.
Proven excellence in all aspects of Medical Affairs.
Expertise in clinical data analysis, including but not limited to clinical outcomes data, clinical trial data, prognostic and predictive biomarkers.
Expertise in data presentation, with an ability to synthesize complex data to create simple and clear conclusions.
Excellent oral and written communication skills.
Excellent planning, organizing, and project management skills.
Strong team leadership capabilities and a desire to interact with and respond to multidisciplinary and cross-cultural teams.
Ability to establish and manage relationships effectively.
Ability to establish and cultivate external partnerships in an effective and self-driven manner.
Exceptional interpersonal and communication skills to deal with all stakeholders.
Mature approach, with the ability to work independently and hands-on without constant supervision.
Strong analytical and strategic thinking skills.
Ability to write, speak, and present information persuasively.
Adherence to high ethical business principles and values.
High emotional intelligence.
High drive, determination, and a collaborative approach to work.
What You Will Do:
Ability to run a clinical program or medical affairs team(s) independently with little supervision.
Understand the current and evolving treatment landscape and pathways across all types of cancer.
Develop and cultivate partnerships outside the organization, including with academics and industry.
Guide and perform clinical analyses, in collaboration with bioinformatics and statistical team members.
Create and give data presentations and publications summarizing the key results of studies.
Understand the competitive landscape of cancer diagnostics, including identifying gaps, opportunities, and needs in the market.
Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in developmental strategy and the protocols.
Leads and partners on the development of multiple asset strategies within the pipeline and strategic governance frameworks.
Provide scientific and technical support for assigned products; deliver scientific presentations; develop and maintain professional and credible relationships with key opinion leaders; actively participate in relevant teams and help develop medical affairs strategies for assigned products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training.
Oversee scientific/medical education of investigators, clinical monitors, and team members.
Maintain knowledge currency of professional information and technology through conferences and/or medical literature.
Craft scientifically accurate materials, medical education programs, advisories, and symposia.
Ensure compliance with applicable organizational policies and procedures.
Clear understanding of regulatory requirements related to the clinical studies and compliance accountability.
Exercise sound judgment within broadly defined practices and policies for obtaining practical and efficient solutions.
Ensure alignment of clinical plans and global development plans.
Ensure commitments are met or exceeded.
Monitor clinical research plan implementation and take corrective action if progress is inadequate.
Monitor other deliverables (e.g., publications, field support) and take corrective action if needed.
Approve and implement local support in clinical research studies to meet business objectives.
Scientific and Technical Expertise
Deep scientific and technical expertise, balancing an understanding of clinical oncology and data analysis with roles in commercialization support with administrative activities.
Critical evaluation of medical literature and competitive product data.
Review proposals and publications.
Provide technical expertise and oversight.
Perform and guide clinical data analyses in support of publications and studies.
Scientific Data Dissemination and Exchange
Ensure timely dissemination of clinical trial data.
Support the critical analysis and dissemination of data through various formats (manuscripts, abstracts, posters, slide sets).
Perform and guide figure generation in support of external presentation and publication of studies.
Establish and maintain collaborations with external experts, thought leaders, and the medical community.
Support planning of symposia, advisory board meetings, and other professional meetings.
Oversee team attendance and scientific congress support.
Business/Customer Support
Ensure medical team compliance with standards for customer interactions.
Provide scientific support for marketing and sales activities.
Partner effectively with internal and external stakeholders.
Regulatory/Submission Responsibilities
Ensure clinical data for regulatory purposes meets required standards.
Participate in advisory committees as assigned.
Administrative Responsibilities
Career Development and Performance Management of direct reports.
Attend assigned meetings and contribute to management, processes, and policy development.
Participate in projects and committees as assigned.
Support plans, budgets, strategic planning, and staff recruiting efforts.
Ensure team members adhere to the highest medical ethical standards.
Implement new process improvement initiatives and best practices.
Act as a liaison with other functions and business units.
Compensation & Benefits:This role is offering a salary between $200,000-$320,000 and is eligible for equity offerings. Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.
The application deadline for this position is November 30, 2024.
You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Travel: Yes, 25% of the Time
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