SENIOR DIRECTOR, REGULATORY ADVERTISING AND PROMOTION
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 will be an instrumental role in preparing Day One’s first commercial product launch. In addition to being a key member of the launch team, she/he will serve on the Promotional Review Committee. This role will report to the VP of Regulatory Science.
This position has the potential to be fully remote. Occasional travel will be required for in person meetings. ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Responsible for providing commercial regulatory leadership for Day One’s initial product launch.
· Conduct review and approval of promotional materials.
· Serve as regulatory liaison to FDA/CDER/OPDP.
· Represent Regulatory Advertising and Promotion at labeling meetings and provide strategic regulatory guidance, as appropriate.
· Provide regulatory guidance on new concepts and new campaigns.
· Maintain a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products. Monitor enforcement trends and provide timely advice to the team.
· Responsible for preparing 2253 submissions to FDA.
· Recognized as an expert resource for regulatory advice across departments.
· May contribute to process improvements relevant to Advertising and Promotion.
· At a minimum, a BA/BS degree; Master’s/PhD/PharmD in life sciences preferred.
· 10-12 years of regulatory experience in pharma/biotech industry, minimum 6 years experience in the regulatory review of promotional materials for prescription drug and/or biologic products. Experience with Accelerated Approval products a plus.
· Direct hands-on experience with OPDP submissions and strategies. Experience with Veeva PromoMats a plus.
· Extensive in-depth knowledge of regulatory requirements associated with advertising and promotion of prescription drug products is required.
· Capable of critically reviewing complex technical/scientific documents and influencing colleagues across functions.
· Requires ability to work both independently and in a team environment, to set priorities to meet timelines, to motivate and influence others.
· Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
· Excellent verbal, written, negotiation, influence and interpersonal communication skills are required.
· Ability to help shape key department goals and objectives, drive process and operational efficiencies, and contribute to ongoing development of innovative best practices both internally and with cross-functional colleagues
· Ability to work independently, establish priorities, and execute with minimal guidance.
· Demonstrated ability to work effectively in a dynamic, complex, and fast-paced team environment.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. COMPENSATION AND BENEFITS
The salary range for this position is $250,000 - $275,000. 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.
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.