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SalarySENIOR MEDICAL DIRECTOR, PHARMACOVIGILANCE AND PATIENT SAFETY
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.
POSITION SUMMARY:
We are seeking a hands-on, experienced Senior Medical Director, Pharmacovigilance and Patient Safety to lead Medical Safety activities 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 and post-market use, and oversight of communication of safety topics across all regulatory safety documents including regulatory authority periodic reports.
This position reports to the VP, Pharmacovigilance and Patient Safety and has the potential to be fully remote. Travel of 10%-15% will be typically required for in-person meetings and conferences.
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
- Supports and provides oversight for 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, including oversight of contractor Safety Physicians as applicable
- Supports VP with implementation of 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 Data Monitoring Committees or assigned products and internal Safety Assessment Committees
- Provides vendor oversight for assigned products where applicable (e.g., CROs contracted for safety reporting)
- Participates in cross-functional project teams including Clinical Trial Study Teams; communicates across organizational levels and functions
- Contributes to the maintenance of the pharmacovigilance system and processes including partnership with Safety Analytics on Rx Logix tool
- Participates in SOP updates, audits, and inspection readiness
- Writes/updates core safety information for assigned projects in collaboration with Safety Operations
- Writes/reviews and provides technical input for the safety sections of regulatory documents for assigned projects including protocols and periodic reports
- Supports preparation of regulatory authority and local/regional ethics board correspondence
- Supports preparation for external meetings with Health Authorities
- Guides and/or trains external personnel/parties involved in Company’s clinical studies where applicable to Medical Safety
- Collaborates effectively in cross-functional and cross-cultural project teams and works 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 Good Vigilance/ Pharmacovigilance Practices as well as internal safety processes, and maintains up-to-date knowledge of regional regulatory guidances
- Willing to participate in workshops and trainings to build skills and knowledge of drug development in pediatric and rare disease
- Managerial responsibilities as necessary
QUALIFICATIONS
- Medical Degree (e.g., MD, MBBS, DO) required
- Training in epidemiology, pharmacology or MPH a plus
- 8+ years’ experience as a Medical Safety Physician or similar experience with safety oversight activities related to clinical trials in academia or industry
- Experience as a leader, mentor or people manager is preferred
- Foundational knowledge of clinical research and global regulatory requirements, and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities, including regulations governing pharmacovigilance
- Strong skills in the management of safety information originating from both clinical development and post-marketing sources
- 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.
COMPENSATION AND BENEFITS
The salary range for this position is $310,000 to $325,000. Day One Bio 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.
DISCLAIMER
Day One 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.
