Associate Director, Toxicology

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Job description

JOB TITLE: Associate Director, Toxicology

LOCATION: SF or Philadelphia Areas

REPORTS TO: Senior Director Translational Research / Science

Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinical 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

SUMMARY:

Day One Biopharmaceuticals is seeking an experienced and talented Toxicologist to join our team. The Associate Director/Director of Toxicology is primarily accountable for selected non-clinical regulatory and investigative toxicology studies. He/she collaborates with other members of the research and clinical development groups, and members of Day One cross-functionmal teams to support and enable the overall global nonclinical regulatory submission strategy for Day One portfolio products. The successful candidate will also be responsible for leading the nonclinical toxicology strategy for development programs for oncology and non-oncology therapeutics. The ideal candidate will thrive working in a fast-paced, multifunctional environment and be passion. This position can be based in the San Francisco Bay area or Philadelphia areas, however remote locations will be considered.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The responsibilities include, but are not limited to:

· Be a motivated, self-started with excellent organizational skills and management capabilities and who will be critical part of an innovative team that supports the company's drug development efforts.

· Conceptualize, develop, revise, and finalize toxicology (GLP and non-GLP) study designs and reports; draft nonclinical sections for IND and NDA/BLA submissions and other regulatory documents (e.g., IB, DSUR, PSUR, etc.) to ensure regulatory compliance.

· Develop overall toxicology strategy and plans to drive successful drug development through global registration and beyond and provide strategic input and guidance on safety assessments for Day One clinical programs and non-clinical programs

· Be a key resource for toxicology, providing deep subject matter expertise and scientific knowledge and advise teams on current nonclinical safety regulation guidelines and standard practices

· Oversee nonclinical safety pharmacology and toxicology evaluation of clinical candidates including designing nad lead investigative toxicology studies and implementation with CRO partners (e.g. protocol design, vendor selection, contracting)

· Work with Study Monitor for protocol development, study monitoring, data and report review for GLP and non-GLP toxicology studies at external CROs per Day One standards, and ensure that global regulatory/compliance requirements are met or exceeded.

· Critically review and edit CRO nonclinical toxicology study reports, analyze and interpret data, define PK/PD and PK/Toxicity correlations, partner in PK modeling and parameter estimation, and coordinate report finalization with CROs upon internal review and team communication, ensuring consistency with global regulatory and compliance requirements

· Communicate findings to key stakeholders, internal and external and support and advance project goals and objectives; partner with and provide subject matter expertise to key internal functions (e.g., regulatory, quality, clinical, CMC/formulations, drug safety, medical affairs) and their external contractors or collaborators.

QUALIFICATIONS:

· Ph.D. in toxicology or related discipline (pharmacology, pathology, biochemistry) and 8+ years of toxicology experience in the Biotech/Pharmaceutical industry as well as DABT certification.

· In-depth understanding of toxicology and experience in designing and critical evaluation of results from exploratory and GLP toxicology studies for small and large molecule programs, with a preference for oncology, cardiology, and CNS indications

· Experience, and a consistent track record of, outsourcing and monitoring toxicology studies, CRO management, and interacting with study directors and other vendors (e.g., consultants) to obtain timely delivery of clear, accurate, and well-written toxicology study reports with defensible data analyses and data interpretation.

· Deep understanding of QA, regulatory, and clinical functions to guide key nonclinical safety assessment activities to support drug candidates' success at all stages of development.

· Capacity to synthesize and communicate complex information.

· Capacity to propose practical mitigation (de-risking) strategies.

· Strong knowledge of FDA, EMA, and ICH guidance documents and GLP regulations.

· Required experience in authoring non-clinical elements of major regulatory submissions (INDs, BLA/NDAs or sNDAs) and other regulatory documents (e.g., IB, PSUR, DSUR); preparing science-based responses to regulatory questions.

· Excellent oral and written communication skills and ability to work as an effective team member in highly collaborative work environment

· Thrives in a fast-paced, multi-tasked, hands-on environment; possesses a sense of urgency.

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within thisfication. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

Day One Biopharmaceuticals is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Recruitment & Staffing Agencies: Day One Biopharmaceuticals do 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 HRteam. 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.

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 sincerely held religious belief.