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HealthfirstDirector, Performance Improvement
Director of Performance Improvement responsible for PI initiatives and team leadership at Healthfirst. Collaborating with operations to enhance business processes and productivity measures.
About the role
- Develop and maintain an understanding of the safety profile of assigned product(s) and relevant strategic context
- Provide Safety Science leadership for clinical development programs and program teams and integrate safety science strategy with clinical development plans
- Provide medical review of cases inclusive of case narratives and causality assessments of AE/SAE reports
- Contribute to drafting safety assessments and drug safety reports for individual cases or aggregate data and respond to Regulatory Authority requests
- Responsible for signal detection and management activities including ISMP maintenance
- Prepare and maintain safety sections of the ISMP, DSUR, IND Annual reports and/or Reference Safety Information in the IB
- Contribute to regulatory authority submissions and provide medical-scientific input to regulatory documents
- Represent Medical Drug Safety in communication with health and regulatory authorities and at Data Safety Monitoring Committee meetings
- Evaluate risk minimization strategies and take accountability for medical-scientific content in Risk Management Plans, including REMS as relevant
- Review clinical protocols, study reports, Investigator's Brochure, informed consent forms and related documents to ensure alignment with safety strategy
- Present important safety issues to program teams for internal and external review
- Serve as safety science representative for clinical trial team meetings or investigator/site meetings
- Support non-molecule projects, due diligence evaluations, and other projects as needed
- Coordinate and collaborate with vendors servicing Safety Science
- Accountable for safety components of study reports, publications, aggregate reports, and high-level regulatory documents
- Perform duties in keeping with company core values, policies, and applicable regulations
Requirements
- Healthcare professional degree required (MD or PharmD highly preferred; other relevant clinical degrees may be considered)
- 6 or more years of drug development experience in the pharmaceutical or related industry
- At least 4 years in drug safety for oncology clinical development
- Broad understanding of safety science and pharmacovigilance (including GVP, GCP) and clinical/patient risk management
- Expert knowledge of regulations governing pharmacovigilance
- Exposure to Safety Operations; experience with drug safety databases (e.g., Oracle Argus) a plus
- In-depth knowledge of clinical research, FDA and international regulations, clinical study design; exposure to early clinical development preferred
- Experience interacting with regulatory authorities (e.g., FDA, EMA) at type C, B, pre-BLA/MAA meetings, Advisory Committee meetings; filing experience highly preferred
- Strong presentation skills; demonstrated ability to achieve high performance goals and meet deadlines
- Strong learning orientation, curiosity, and commitment to science and patients
Benefits
- Paid Time Off
- Holiday and Sick Leave
- Medical, Dental and Vision Plans
- Short- and Long-Term Disability
- Basic and Voluntary Life/AD&D Coverage
- Flexible Spending Accounts (FSA, HSA, and Commute)
- Critical Illness and Accident Coverage
- Pet Insurance
- Employee Assistance Program
- 401(k) Plan with Erasca contribution
- Annual bonus and an equity grant at hire and annually (option to purchase stock)
- Hybrid or fully remote work options within the United States
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