Director, Medical Affairs Strategy and Operations
DIRECTOR, MEDICAL AFFAIRS STRATEGY AND OPERATIONS
At Day One, we are focused on advancing first- or best-in-class medicines for childhood and adult diseases with equal intensity. We were founded to address the lack of new therapies resulting from the traditional drug development model, that has left children with cancer and their families waiting too long for new, life-changing treatments. Our aim is to accelerate better, targeted treatments so patients of any age can look forward from 'day one' to the future they've envisioned.
POSITION SUMMARY:
The Director, Medical Affairs Strategy and Operations will serve as a strategic and operational leader for Medical Affairs, driving planning, alignment, and execution across the function. Act as a thought partner to the VP Medical Affairs, while ensuring seamless operational delivery, compliance, and impact measurement for Medical Affairs initiatives. This position will report to the Senior Director, R&D Head of Strategy & Operations.
This position has the potential to be fully remote. Occasional travel will be required for in person meetings.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Strategic Partnership & Leadership
• Act as strategic thought partner to VP, Medical Affairs, supporting leadership of Medical Affairs Leadership Team (MA-LT) operations and cross-functional alignment.
• Lead Medical Affairs strategic and tactical planning cycles (annual functional plan, Integrated Evidence Generation Plan (IEGP), publications, scientific communications plan, etc.).
• Drive strategic initiatives to evolve Medical Affairs (e.g., Med Affairs 2.0, upskilling field teams, process optimization).
• Integrate insights from internal and external sources into strategic recommendations and portfolio decision-making.
Operational Leadership & Governance
• Oversee Medical Affairs budget and resource allocation in partnership with Finance, ensuring alignment with Program Team (PT) and corporate goals.
• Develop and manage functional dashboards, Key Performance Indicators (KPIs), and operational metrics to measure impact and enable informed decision-making.
• Ensure inspection readiness and adherence to regulatory/compliance standards across Medical Affairs deliverables.
Program & Vendor Oversight
• Provide operational leadership for Investigator Sponsored Trials (ISTs), Compassionate Use Program (CUP)/ Expanded Access Program (EAP), Contiuing Medical Education (CME) grants, congress operations, and (Key Opinion Leader) KOL engagement.
• Manage vendor relationships, contracting operations, Fair Market Value (FMV) processes, and Needs Assesment Form (NAF) navigation.
Execution & Infrastructure
• Oversee functional financial operations (bills, tracking, vendor oversight).
• Ensure systems, tools, and shared repositories are well-maintained and consistently utilized.
• Coordinate internal Medical Affairs meetings, logistics for congresses, and KOL engagement scheduling.
• Support execution, documentation, and reporting for ISTs, CUP, and grants/sponsorships.
• Share best practices across Medical Affairs to improve efficiency and standardization.
QUALIFICATIONS
• Bachelor's degree required (preferably in a healthcare-related, scientific, or business discipline); advanced training in project management preferred.
• Minimum 10+ years of experience in Medical Affairs operations or related functions within the pharmaceutical/biotech industry, with at least 5 years in a leadership capacity
• Proven success in leading Medical Affairs programs and projects and an ability to manage and develop teams, including direct reports and external contractors.
• Demonstrated experience in project management, budget oversight, and process optimization in in a dynamic, fast-paced environment.
• Expertise in managing operational systems, metrics reporting, and budget oversight.
• Experience managing external collaborations and overseeing vendor relationships, contracts, and FMV processes.
• Strong understanding of compliance, regulatory, and inspection readiness requirements for Medical Affairs.
• Excellent organizational, strategic thinking, and communication skills.
• High degree of integrity and commitment to compliance and quality.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.
INTERVIEW INTEGRITY
At Day One, we expect each candidate to engage authentically, representing their true qualifications and experiences. As part of our screening process, we will conduct several interviews and background verification. This ensures candidates have the skills they claim and align with our values. We are excited to learn more about you and to create a genuine experience for everyone.
COMPENSATION AND BENEFITS
The salary range for this position is $230,000 - $250,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.
Please visit https://www.dayonebio.com/benefits to see our competitive benefits.
DISCLAIMER
Day One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.
Employment is conditioned upon full vaccination from the COVID-19 virus, including submission of documented proof thereof, as of the start date. Day One Biopharmaceuticals will comply with applicable law regarding the reasonable accommodation of individuals who are not vaccinated because of a disability and/or a sincerely held religious belief.
We are unable to sponsor or take over sponsorship of any applicant work visas at this time.
Recruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceutical's internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.
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At Day One, we are focused on advancing first- or best-in-class medicines for childhood and adult diseases with equal intensity. We were founded to address the lack of new therapies resulting from the traditional drug development model, that has left children with cancer and their families waiting too long for new, life-changing treatments. Our aim is to accelerate better, targeted treatments so patients of any age can look forward from 'day one' to the future they've envisioned.
POSITION SUMMARY:
The Director, Medical Affairs Strategy and Operations will serve as a strategic and operational leader for Medical Affairs, driving planning, alignment, and execution across the function. Act as a thought partner to the VP Medical Affairs, while ensuring seamless operational delivery, compliance, and impact measurement for Medical Affairs initiatives. This position will report to the Senior Director, R&D Head of Strategy & Operations.
This position has the potential to be fully remote. Occasional travel will be required for in person meetings.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Strategic Partnership & Leadership
• Act as strategic thought partner to VP, Medical Affairs, supporting leadership of Medical Affairs Leadership Team (MA-LT) operations and cross-functional alignment.
• Lead Medical Affairs strategic and tactical planning cycles (annual functional plan, Integrated Evidence Generation Plan (IEGP), publications, scientific communications plan, etc.).
• Drive strategic initiatives to evolve Medical Affairs (e.g., Med Affairs 2.0, upskilling field teams, process optimization).
• Integrate insights from internal and external sources into strategic recommendations and portfolio decision-making.
Operational Leadership & Governance
• Oversee Medical Affairs budget and resource allocation in partnership with Finance, ensuring alignment with Program Team (PT) and corporate goals.
• Develop and manage functional dashboards, Key Performance Indicators (KPIs), and operational metrics to measure impact and enable informed decision-making.
• Ensure inspection readiness and adherence to regulatory/compliance standards across Medical Affairs deliverables.
Program & Vendor Oversight
• Provide operational leadership for Investigator Sponsored Trials (ISTs), Compassionate Use Program (CUP)/ Expanded Access Program (EAP), Contiuing Medical Education (CME) grants, congress operations, and (Key Opinion Leader) KOL engagement.
• Manage vendor relationships, contracting operations, Fair Market Value (FMV) processes, and Needs Assesment Form (NAF) navigation.
Execution & Infrastructure
• Oversee functional financial operations (bills, tracking, vendor oversight).
• Ensure systems, tools, and shared repositories are well-maintained and consistently utilized.
• Coordinate internal Medical Affairs meetings, logistics for congresses, and KOL engagement scheduling.
• Support execution, documentation, and reporting for ISTs, CUP, and grants/sponsorships.
• Share best practices across Medical Affairs to improve efficiency and standardization.
QUALIFICATIONS
• Bachelor's degree required (preferably in a healthcare-related, scientific, or business discipline); advanced training in project management preferred.
• Minimum 10+ years of experience in Medical Affairs operations or related functions within the pharmaceutical/biotech industry, with at least 5 years in a leadership capacity
• Proven success in leading Medical Affairs programs and projects and an ability to manage and develop teams, including direct reports and external contractors.
• Demonstrated experience in project management, budget oversight, and process optimization in in a dynamic, fast-paced environment.
• Expertise in managing operational systems, metrics reporting, and budget oversight.
• Experience managing external collaborations and overseeing vendor relationships, contracts, and FMV processes.
• Strong understanding of compliance, regulatory, and inspection readiness requirements for Medical Affairs.
• Excellent organizational, strategic thinking, and communication skills.
• High degree of integrity and commitment to compliance and quality.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.
INTERVIEW INTEGRITY
At Day One, we expect each candidate to engage authentically, representing their true qualifications and experiences. As part of our screening process, we will conduct several interviews and background verification. This ensures candidates have the skills they claim and align with our values. We are excited to learn more about you and to create a genuine experience for everyone.
COMPENSATION AND BENEFITS
The salary range for this position is $230,000 - $250,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.
Please visit https://www.dayonebio.com/benefits to see our competitive benefits.
DISCLAIMER
Day One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.
Employment is conditioned upon full vaccination from the COVID-19 virus, including submission of documented proof thereof, as of the start date. Day One Biopharmaceuticals will comply with applicable law regarding the reasonable accommodation of individuals who are not vaccinated because of a disability and/or a sincerely held religious belief.
We are unable to sponsor or take over sponsorship of any applicant work visas at this time.
Recruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceutical's internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.
Apply tot his job
Apply To this Job