DIRECTOR, REGULATORY SCIENCE
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 Director, Regulatory Science will be the regulatory lead for one or more oncology development programs and work closely with cross-functional teams and development partners to execute the global regulatory strategy in line with the Project Team’s goals, Health authority expectations, and ICH requirements. As a key member of the Project Team, she/he will support the integrated development plan for a Phase 1 Antibody-Drug Conjugate, and be responsible for developing and implementing the global regulatory strategy. This role will report to the SVP of Regulatory Science and GCP Quality.
This position has the potential to be fully remote. Occasional travel will be required for in person meetings.
Essential Duties And Responsibilities
- Deliver sound regulatory strategy to Project Team(s) as the Regulatory Science subject matter expert and present to senior leadership as required.
- Identify and propose risk mitigation strategies, and influence project teams and sub-teams.
- Ensure regulatory strategy takes account of competitive developments, regulatory precedent, expert feedback, and that advice is aligned with company goals and objectives.
- Serve as regulatory liaison to FDA.
- Motivate, mentor, and develop direct report(s).
- Establish highly collaborative and effective relationships with cross-functional colleagues.
- Serve as an expert resource for regulatory advice across departments.
- Contribute to process improvements.
Qualifications
- At a minimum, a BA/BS degree; Master’s/PhD/PharmD in life sciences preferred.
- At least 10 years of regulatory experience in pharma/biotech industry.
- Antibody-Drug Conjugate and/or biologics experience strongly preferred.
- Direct experience with oncology drug development strongly preferred.
- 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.
- Excellent verbal, written, negotiation, influence and interpersonal communication skills are required.
- Ability to work independently, establish priorities, and execute with minimal guidance.
- Responsibilities may at times require working outside of “normal” work hours in order to meet business demands and/or health authority timelines.
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 $215,000 - $230,000. 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.
