Day One Biopharmaceuticals
Remote · Sterling, VA, USA
Posted on Tuesday, August 15, 2023
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.
Day One Biopharmaceuticals is seeking an experienced and talented Director of Toxicology responsible to fulfill all toxicology requirements to support our drug development programs. This role will be collaborative with cross-functional sub teams and consultants to support nonclinical and clinical development and regulatory submissions for Day One portfolio products. The successful candidate will also be responsible for leading the nonclinical toxicology strategy for development programs for both oncology and non-oncology therapeutics. The ideal candidate will thrive working in a fast-paced, multifunctional environment.
This position is preferred to be based in the San Francisco Bay Area, however the potential to be fully remote will be considered. Occasional travel will be required for in person meetings.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Serve as the toxicology lead and subject matter expert on cross-functional teams for drug development programs
· Develop overall toxicology strategy and plans to drive successful drug development through global registration
· Lead authoring of nonclinical sections for IND and NDA/BLA submissions and other regulatory documents (e.g., IB, DSUR, PSUR, etc.) to ensure regulatory compliance
· Work with Study Monitor for protocol development, data and report review for GLP and non-GLP toxicology studies at CROs
· Review reports in collaboration with cross-functional team members
· Effectively communicate findings with project teams and senior management
· Build and maintain strong collaborative relationships with cross-functional team members
· Be a motivated self-starter with excellent organizational skills
· Ph.D. in toxicology or related scientific discipline
· 10+ years of toxicology experience in the biotech/pharmaceutical industry along with DABT certification
· Knowledge of GLP regulations and relevant ICH, FDA and EMA guidance documents
· Extensive experience in small molecule drug development
· Preferred experience in oncology, cardiology, and CNS indications and reprotoxicology studies
· Experience and a consistent track record of outsourcing toxicology studies, CRO management, and interacting with study directors and other vendors
· Required experience in authoring nonclinical elements of major regulatory submissions (INDs, BLA/NDAs or sNDAs) and other regulatory documents (e.g., IB, PSUR, DSUR)
· Excellent oral and written communication skills and ability to work as an effective team member in a highly collaborative work 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 $225,000 - $240,000. 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.
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.