Associate Director, Patient Safety Quality and Compliance

ASSOCIATE DIRECTOR, PATIENT SAFETY QUALITY 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:

We are searching for a creative, resourceful, integrative thinker for an important role that will be responsible for safety quality and compliance activities.

The Director/Associate Director, Safety Quality and Compliance will be responsible for supporting the development and management of quality infrastructure and processes pertaining to safety and pharmacovigilance. The candidate will contribute to activities such as inspection readiness, internal audits and global regulatory inspections, assist with strategies for all agreements where safety activities and input is required, and building robust, compliant processes to ensure the company’s success in continued growth and expansion. This position requires a candidate with strong cross-functional skills and communication, a desire to help the team meet fast-paced growth into global territories and be self-motivated.

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

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Where applicable work independently and collaboratively with the Senior Director, Safety Operations and Compliance and the Senior Director GCP Quality Assurance to perform the following:

Assist with the development and implementation of best practices to ensure safety systems and processes are compliance with global regulations
Review new regulatory requirements and perform impact analysis to existing processes
Establish key performance metrics to measure compliance and data quality
Develop and deliver periodic safety system compliance reports, including relevant metrics, to key stakeholders and senior leadership
Contribute to due diligence and/or pre-qualification activities of vendors needed to support safety activities
Support the global strategy and compliance requirements for safety data exchange agreements (SDEA)/PV agreements (PVA), Investigator Sponsored Trials (ISTs), and Expanded Access Programs (EAPs), ensuring compliance with global regulations
Incorporate industry leading innovative initiatives aimed at improving effectiveness of surveillance, signal detection and risk mitigation strategies for both marketing and developing therapies
Serve as the safety subject matter expert on cross-functional committees relating to training and standards within the company
Support the R&D Quality organization with internal and external safety audit and inspection activities
Review and analyze audit, inspection and CAPA data to identify compliance trends and areas of exposure related to safety
Work closely with R&D Quality, PV Operations, Regulatory etc. to manage CAPA activities related to R&D Safety department (initiation and preparation of investigational activities)
Support the organization global submission activities for product approval
Supports the creation of systems and processes [(including EU PSMF, reviewing and/or writing Standard Operating Procedures (SOPs) and Work Instructions (WI)] to support business expansion efforts, in collaboration with the Sr. Director GCP Quality Assurance

QUALIFICATIONS

Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in PV. Bachelor’s degree is minimal and Master’s degree, PharmD, PhD in Life Sciences, MD, DO, or MBBS are preferred
4+ years in the pharmaceutical industry setting; 2+ years’ experience working in Safety and Pharmacovigilance, specifically within quality and compliance
Oncology experience is preferred
Extensive experience in safety quality systems, compliance monitoring, and the development and maintenance of standards and training programs
Strong knowledge and experience with available drug safety database systems, document management systems, and QC tools, as well as MedDRA
Expert knowledge of FDA, EMA, Asia-PAC, and ICH regulations and guidelines
Demonstrated problem-solving and critical thinking skills
Excellent interpersonal, communication, analytical, and organizational skills
Strong computer skills desirable, particularly Power Point preparations
Demonstrated ability to work effectively in a dynamic, complex, and fast-paced team environment
Track record of strong personal performance combined with demonstrated ability to build and lead high performing teams
Strong people and project management experience

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.