Senior Director, Medical Operations and Analytics

Atlas Venture; United States; Remote; USD 300,000 - 315,000; Full time

Job summary

A leading biopharmaceutical company seeks a Senior Director of Medical Operations and Analytics to enhance operational excellence within Medical Affairs. This role involves managing budgets, driving project accountability, and ensuring compliance in a dynamic environment. The ideal candidate will have extensive experience in Medical Affairs and a strong leadership background, thriving in a mission-driven biotech setting. The position may be fully remote with occasional travel required.

Qualifications

• Minimum 12+ years in Medical Affairs operations, 5 years in leadership.
• Expertise in managing operational systems and metrics reporting.
• Strong understanding of compliance and regulatory requirements.

Responsibilities

• Drive operational excellence across Medical Affairs deliverables.
• Oversee Medical Affairs budget and ensure compliance.
• Manage vendor relationships and operational oversight.

Skills

Project Management

Budget Oversight

Process Optimization

Strategic Thinking

Communication

Education

Bachelor’s degree

Advanced training in project management

Job description

Senior Director, Medical Operations and Analytics

About Day One Biopharmaceuticals

Day One Biopharmaceuticals understands that advances in cancer research now enable drug developers to identify children and adults who may benefit from the same medicine.

About Day One Biopharmaceuticals

Day One Biopharmaceuticals understands that advances in cancer research now enable drug developers to identify children and adults who may benefit from the same medicine.

Job Description

Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinically evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages. For more information, please visit our website at http://www.dayonebio.com.

POSITION SUMMARY:

The Senior Director, Medical Operations and Analytics will play a critical leadership role within the Medical Affairs organization. This position will drive operational excellence and organizational efficiency across Medical Affairs deliverables. This includes oversight of project management across the function, budget planning and management, process optimization, vendor management, and inspection readiness, ensuring seamless execution of all core Medical Affairs deliverables. The ideal candidate brings a strong track record of operational leadership and excellence within Medical Affairs, a deep understanding of the biotech/pharmaceutical environment, and thrives in a mission-driven, fast-paced biotech environment. This role reports to the Vice President, Medical Affairs.

This position has the potential to be fully remote. Occasional travel of 10%-15% will be required for in-person meetings.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Provide comprehensive project management to drive accountability across all core Medical Affairs deliverables, including annual Medical Affairs Strategic planning, evidence generation and publication plans, and other strategic and tactical deliverables.
• Oversee development, refinement, and reporting of key Medical Affairs functional metrics and operational dashboards to drive performance and accountability.
• Lead and manage the Medical Affairs functional budget, ensuring operational efficiency and alignment with organizational goals.
• Provide operational oversight for the Expanded Access Program (EAP) / Compassionate Use Program (CUP) and Investigator Sponsored Trials (ISTs), ensuring compliance and alignment with clinical and regulatory standards.
• Refine and manage processes, driving continuous improvement and operational efficiency, to support the timely and consistent delivery of functional objectives across the Medical Affairs portfolio
• Oversee and manage the logistical execution of Medical Affairs congress presence and strategy, ensuring effective planning and execution
• Partner with other Medical Affairs functional leaders to drive the assimilation of Medical Affairs insights reports, synthesizing internal and external data to inform strategy and decision-making
• Manage vendor and consulting agreements with external medical experts and partners, including oversight of Fair Market Value (FMV) assessments/systems and contracting processes
• Manage the MLR (Medical, Legal, Regulatory) review and Data on File (DOF) systems and processes, ensuring compliance and timely review of externally-facing materials.
• Oversee Continuing Medical Education (CME) grants process in alignment with compliance and policy standards.
• Ensure inspection readiness for GXP-related activities and ensure systems, documentation, and processes are in place for audit preparedness.
• Manage and develop direct reports and contractors, fostering a culture of high performance, accountability, and continuous improvement.

QUALIFICATIONS

• Bachelor’s degree required (preferably in a healthcare-related, scientific, or business discipline); advanced training in project management preferred.
• Minimum 12+ years of experience in Medical Affairs operations or related functions within the pharmaceutical/biotech industry, with at least 5 years in a leadership role
• 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.

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 $300,000-$315,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.

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.