VICE PRESIDENT, REGULATORY SCIENCE

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:

Day One is hiring an experienced leader who will continue to grow a high-performing Regulatory function for a fast-growing biotechnology company. Reporting to the Chief Development Officer, the Vice President, Regulatory Science will build out and oversee the Regulatory Strategy, Medical Writing, Regulatory Operations, Regulatory Ad Promo, and Regulatory CMC functions.

This position has the potential to be fully remote with a preference for San Francisco Bay Area or Boson Area locations. Occasional travel will be required for in person meetings.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Develop, implement and maintain global regulatory strategies across all phases of drug development from IND/CTA preparation through product approval and the post-marketing setting
• Further build the regulatory and quality functions, build, and maintain strong leadership capabilities at all levels within the team and support the professional development of team members
• Oversee U.S. / international submissions and strategic interactions with Health Authorities
• Oversee submission and maintenance of global regulatory filings
• Assure compliance with relevant regulations and guidelines
• Communicate with and manage consultants, CROs, and other vendors
• Develop regulatory strategies and submission plans to achieve submission milestones and marketing authorization in support of development timelines and corporate goals
• Oversee regulatory activities, including the preparation, review and submission of regulatory documents such as meeting requests, briefing documents, Health Authority responses, clinical trial / marketing applications, pediatric plans, product labeling
• Submission and life-cycle maintenance of US and international regulatory filings
• Oversee and have accountability for CMC Regulatory Submissions
• Perform other duties as required, interfacing with other departments, CROs and external vendors as needed
• Act as primary point of contact for external collaborations (e.g. ex-US markets)

QUALIFICATIONS

• At a minimum, a BA/BS degree; Master’s/PhD/PharmD in life sciences preferred.
• At least 15 years of experience in pharma/biotech industry in Regulatory Science, overseeing internal and vendor staff
• Experience in building teams and managing people
• Strong strategic and analytical abilities
• Working knowledge of the Code of Federal Regulations and FDA, EMA and ICH guidelines
• Expert knowledge of FDA and ICH GxP regulations and guidelines, across all disciplines including GLP, GCP, and GVP.
• FDA Investigational New Drug Applications (IND), New Drug Applications (NDA), Biologics Liscence Application (BLA) and Drug Master Files (DMF) submission experience
• NDA / CTD dossier preparation, management and submission experience
• Product label development and management experience
• Knowledge and understanding of product life-cycle post-approval management
• 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
• Excellent interpersonal, communication, analytical, and organizational skills

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 $325,000-345,000. 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.

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.