Senior Medical Director, Pharmacovigilance and Patient Safety

SENIOR MEDICAL DIRECTOR, PHARMACOVIGILANCE AND PATIENT SAFETY

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 seeking a hands-on, experienced Senior Medical Director, Pharmacovigilance and Patient Safety to lead the clinical safety strategy for assigned drug projects and products, provide drug safety expertise and guidance to Clinical Development and cross-functional Clinical Project Teams, and drive proactive implementation of risk management initiatives in accordance with global regulatory requirements. This position will involve continuous, efficient monitoring of safety data to perform signal evaluation and predict and manage the safety profile of compounds in clinical development, consistent communication of safety topics across all regulatory safety documents, and strategic collaboration with external partners. Of key importance is the proven ability to lead the safety portions of an NDA for a small molecule.

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

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature, and other information sources in order to predict/establish the safety profile of compounds in clinical development
Leads Safety contributions to submission of NDA for a targeted therapy
Reviews and/or performs medical review of case narratives for medical content, accuracy, and signal detection
Interprets aggregate safety data for periodic reports and evaluating for potential new signals
Leads signal detection, signal evaluation, data analysis, and benefit-risk evaluation for assigned compounds
Leads risk management and mitigation activities, including medical and safety leadership for Risk Management Plans
Writes individual case assessments and evaluates aggregate safety data for periodic reports
Provides medical input into identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals
Offers medical judgment on complex safety issues
Presents safety data to DSMBs for assigned products and internal Safety Assessment Committees
Contributes to/reviews the Safety Data Exchange Agreements and other documents shared with partners; provides vendor oversight for assigned products
Participates in cross-functional project teams; communicates across organizational levels and functions
Contributes to the maintenance of the pharmacovigilance system and processes
Participates in SOP updates, audits, and inspection readiness
Writes/updates core safety information for assigned projects
Writes/reviews and provides technical input for the safety sections of regulatory documents for assigned projects (i.e., protocols, IBs, ICFs, CSRs, IND submissions, annual reports, DSURs, etc.)
Prepares and/or reviews safety documents and provides strategic input into responses to regulatory inquiries
Participates in external meetings with Health Authorities
Participates in non-regulatory meetings, including those with consultants and other companies, such as licensing partners
Guides and/or trains external personnel/parties involved in Company’s clinical studies
Collaborates effectively in cross-functional and cross-cultural project teams and environments, and work with external providers
Maintain clinical and technical expertise in the therapeutic areas, i.e., through review of scientific journals, attendance at scientific and key technical meetings, etc.
May participate/present safety material to Company and Investigator’s meetings and other medical meetings
Participates in selection and bidding activities for vendors and contractors
Ensures that safety science practices comply with GVP as well as internal safety processes
Managerial responsibilities as necessary

QUALIFICATIONS

Medical degree (e.g., MD, MBBS, DO) Training in epidemiology, pharmacology or MPH is an additional asset
At least 8 years minimum experience as a Medical Safety Physician or similar pharmacovigilance leadership role in the pharmaceutical or biotechnology industries
Experience as a leader, mentor and people manager is of value
A thorough knowledge of clinical research and global regulatory requirements, and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities
Strong skills in the management of safety information originating from both clinical development and post-marketing sources
Expert knowledge of the regulations governing pharmacovigilance
Working knowledge of industry standard pharmacovigilance databases, particularly Argus
Strong leadership skills and ability to communicate with individuals at all levels
Excellent oral and written communication skills
Excellent analytical skills, detail-oriented, and ability to work independently
Ability to exercise creativity and judgment

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 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.