SENIOR DIRECTOR, SAFETY OPERATIONS AND COMPLIANCE                       

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 http://www.dayonebio.com.       

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POSITION SUMMARY: 

Safety Remote, United States 

The Senior Director, Safety Operations and Compliance will serve as a safety expert accountable for the oversees planning, implementation, and management of Safety Operations and Compliance activities in support of the Day One Biopharmaceutical’s development portfolio, in close collaboration with other Safety and Medical staff. This individual must be able to work effectively in a matrix, with multiple other departments across the organization, and with external stakeholders such as Investigators and Regulatory Agencies. This position will report to the Vice President of Pharmacovigilance and Patient Safety.

This position has the potential to be fully remote. Occasional travel may be required for in person meetings.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Responsible for the strategic planning, implementation, and management of Safety Operations activities
  

•  Responsible for leading, supporting, and managing the relationships with the safety vendor(s) to ensure effectiveness, quality, and compliance of outsourced activities
  

•  Ensures timely submission of expedited safety reports to Regulatory Authorities in conjunction with the safety vendor, clinical CROs, and Regulatory Operations
  

• Responsible for safety management plans, and associated documents to ensure that study-specific and Regulatory Authority reporting requirements are met and that workflow between CROs, and Day One Biopharmaceuticals are clearly delineated and followed
  

• Responsible for the development and maintenance of Safety Data Exchange Agreements with Day One Biotherapeutic’s partners and ensures compliance with the agreed upon terms
  

• Reviews the safety sections of clinical documents, including the safety reporting section of protocols
  

• Responsible for the development, implementation, and maintenance a Safety quality management system including the identification and authoring of required procedural documents to ensure compliance with global regulations
  

• Responsible for the development of internal and external (with vendors) key performance indicators and metrics to track performance
  

• Serves as the Safety subject matter expert for internal audits and global inspections. Responsible for identifying and following-up on corrective action plans arising from audits and inspections
• Responsible for safety inspection readiness activities and preparation and works in collaboration with GCP Quality to align on scheduling of audits for safety vendors
  

• Collaborates with Clinical Quality to ensure awareness and training of appropriate Day One Biopharmaceuticals personnel to Safety specific policies and SOPs as appropriate
  

• Responsible for hiring and providing managerial support to direct reports with overall responsibility of leading, training, and mentoring for effective performance
  

• Effectively collaborates with key stakeholders of cross-functional departments to meet corporate and departmental goals

QUALIFICATIONS

• Bachelor’s Degree in Health Care of Life Sciences at minimum. Masters degree, PharmD, PhD in Life Sciences, MD, DO, MBBS are preferred
  

• 10+ years’ experience in Pharmacovigilance. Oncology experience preferred
  

• Track record of strong personal performance combined with demonstrated ability to build and lead high performing teams
  

• Ability to establish and identify best practices for continuous improvement of case quality, compliance, and process improvement
  

• Demonstrates the ability to handle increasing responsibilities as scope may change relate to team growth and integration efforts cross-functionally
  

• 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
• Thorough knowledge and experience in safety reporting in both the clinical trial and post-market settings
  

• Strong knowledge and experience with available drug safety database systems, document management systems, and QC tools
  

• Extensive experience participating in inspections/audits and leading efforts around related CAPAs
  

• Demonstrated ability to work effectively in a dynamic, complex, and fast-paced team environment
  

• Expert knowledge of global safety regulations and guidelines
  

• Excellent interpersonal, communication, analytical, and organizational skills
  

• Strong computer skills desirable, particularly Power Point preparations
  

• Strong and positive people and project management experience
  

• Experience with auditing/planning audits is preferable
  

The preceding job description has been designed to indicate the general nature and level of work performed by employees within classification. 

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DISCLAIMER

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.

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.

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 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.