Associate Director, Medical Affairs Operations

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 Associate Director Medical Affairs Operations is a pivotal role that offers strategic project management expertise and oversight to support the Medical Affairs team. This position provides operational and scientific support of key initiatives to ensure their successful implementation including but not limited to the areas of Investigator Sponsored Trials (IST), Expanded Access Program (EAP), Medical Affairs operations, and process improvement. This role provides an outstanding opportunity to work in a cross-functional environment. This role interfaces with Regulatory Affairs, Global Clinical Supply Chain, Drug Safety, Information Technology, Commercial, Compliance and Legal departments. Strong communication skills, attention to detail, and the ability to learn and master skills are essential to success. This position has the potential to be fully remote. Occasional travel will be required for in person meetings.

Essential Duties And Responsibilities

• Provide strategic project management skills to support activities across Medical Affairs and cross-functional stakeholders.
• Project plan, coordinate activities and manage timelines and deliverables within Medical Affairs/Day One and third-party vendors.
• Schedule, organize, and drive team meeting(s), prepare and distribute agendas, minutes, and maintain action and decision and risk logs.
• Oversee and ensure tracking and movement with Medical Affairs SOPs and work with Quality to track compliance issues to completion.
• Provide operational expertise and support for the Investigator Sponsored Trial (IST) program with functional area oversight to ensure quality of work and appropriate compliance with regulatory requirements.
• Lead, interact, collaborate and integrate processes with functional area peers within Medical Affairs, Clinical Development, Drug Supply, Regulatory, Translational Research, Compliance and Legal to activate studies in a manner consistent with relevant SOPs and processes on ISTs.
• Ensure all IST program records are kept up to date and accessible for team use and audit-readiness.
• Assist with the budget negotiation process for Medical Affairs Operations projects, including Fair Market Value (FMV) assessment for all IST budgets and amendments. Facilitate work to define or refine related processes, where necessary.
• Review and assist in the writing or revision of department or cross functional process manuals.
• Assist with other duties related to the operations of the IST program, including facilitation and management of cross-functional work-streams.
• Oversee the operational management of patients receiving products under expanded access programs.
• Collaborating with internal and external stakeholders to navigate regulatory pathways to expanded access.
• Assist with other duties related to the Medical Affairs Operations function.

Qualifications

• Master's Degree or higher in a relevant field such as Life Sciences, Business Administration, or a related discipline.
• Minimum 5 years industry experience, Medical Affairs strongly preferred.
• Experience working in investigator-initiated research programs, clinical trial development, and/or research management.
• Experience with vendor management, budgets, purchase order and invoicing.
• Strong analytical and organizational skills with the ability to focus on detailed information.
• Strong project management skills and ability to multitask required.
• Strong written and verbal communication skills required.
• Advanced MS Office skills required.

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 $180,000 - $195,000. 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.