Director or Sr Director, Safety Science
Director or Sr Director, Safety Science
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$ 230000 - 320000
1 Vacancy
Job Description
Erascais a clinical-stage precision oncology company focused on discovering developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancersmost commonly mutated signaling cascades the RAS/MAPK pathway which affects approximately 5.5 million lives each year worldwide. The name Erasca has an important embedded meaning: it is a contraction of our audacious hope to erase cancer that drives our mission and everything that we do on behalf of patients with cancer.
The Director or Senior Director Safety Science will provide safety science and pharmacovigilance support to molecules across the Erasca portfolio. The position will support early and late phase development activities as a member of the safety team providing essential safety oversight and input into all aspects of study management across the entire development portfolio. They will bring safety expertise to interactions with internal stakeholders and regulatory authorities and must have the ability to interact effectively in amultifunctional and multicultural team setting. Additionally the Director or Sr Director Safety Science will work closely with Safety Operations for case review medical review and study oversight for patient safety.
Note this position can be hybrid in our San Diego or South San Francisco locations or fully remote anywhere in the United States.
Essential Duties and Responsibilities:
- Develop and maintain an understanding of the safety profile of assigned product(s) as well as understanding of the relevant strategic context (e.g. disease under study safety profile of competitors mechanism of action).
- Provide Safety Science leadership for clinical development programs and program teams and integrate safety science strategy aligned with clinical development plan(s).
- Provide medical review of cases inclusive of case narratives and causality assessments of AE/SAE reports.
- Contribute to the drafting of safety assessments and drug safety reports for individual cases or aggregate data for signals or in response to Regulatory Authority requests.
- Responsible for signal detection and management activities including but not limited to ISMP maintenance.
- Responsible for the preparation and maintenance of 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 for safety-related requests from health authorities and other external parties.
- Represent Medical Drug Safety in communication with health and regulatory authorities and at independent Data Safety Monitoring Committee meetings.
- Evaluate risk minimization strategies and take accountability for the medical-scientific content in Risk Management Plans including risk minimization measures risk minimization action plans and REMS programs as relevant.
- Review clinical protocols study reports Investigators Brochure (IB) informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication.
- 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.
- May support non-molecule projects due diligence evaluations and other projects as needed.
- Responsible for coordination and collaboration with vendors servicing Safety Science.
- Accountable for the safety components of study reports publications aggregate reports and high-level regulatory documents.
- Perform all duties in keeping with the Companys core values policies and all applicable regulations.
Education and Experience
- Healthcare professional degree . 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 including at least 4 years in drug safety for oncology clinical development.
- Broad understanding of the scientific aspects of safety PV (including GVP GCP) and clinical/patient risk management is essential.
- Expert knowledge of regulations governing pharmacovigilance.
- Exposure to Safety Operations and experience with data entry and administration of drug safety databases such as Oracle Argus a plus.
- In depth knowledge of clinical research including FDA and international regulations clinical study design and documentation; exposure to early clinical development preferred.
- Experience interacting with regulatory authorities (i.e. FDA EMA) at type C B pre-BLA/MAA meetings Advisory Committee meetings or other scientific advice forums ; filing experience highly preferred.
- Strong presentation skills effective at summarizing and presenting key considerations and decision points.
- Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
- Strong learning orientation curiosity and commitment to science and patients.
The anticipated salary range for this position is $230000 to $320000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry education addition to base salary the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price.
Along with our casual collaborative and fun work and the chance to make your mark in our mission to erase cancer Erasca offers a comprehensive and competitive benefits package that includes: 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 and the opportunity to participate in an Employee Stock Purchase Program.
Erasca Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of sex race religion national origin ancestry physical or mental disability protected medical condition genetic information marital status registered domestic partner status age sexual orientation military and veteran status or any other basis protected by federal state or local law or ordinance or regulation.
Required Experience:
Exec
Employment Type
Full Time
