Manager, Safety Analysis Scientist – Cell Therapy
About The Position
The Manager, Safety Analysis Scientist (SAS) partners with the Medical Safety Officer (MSO) to prepare scientific safety analyses and evaluations for regulatory compliance and safety-related decisions concerning marketed products and products in development. The role supports product Safety Management Teams (SMTs) and collaborates with cross-functional safety partners to shape product safety strategy, complete scheduled and ad hoc safety analyses, proactively review safety data, and lead safety data review meetings. The position leads safety evaluations from strategy discussions and data retrieval through analysis, report writing, and revision. It also supports regulatory and clinical documents, SMT deliverables, Health Authority interactions, cross-functional training, controlled documents, audits, and inspections. The role contributes to improving reporting and data presentation practices and mentors other Safety Analysis Scientists.
Requirements
- Bachelor’s degree or higher in a healthcare-related field or biomedical science.
- At least 6 years of relevant clinical and/or industry experience.
- Working knowledge of medical concepts and familiarity with safety activities in drug development and post-marketing, as well as global safety Health Authority requirements.
- Ability to understand and analyze complex medical-scientific data from a broad range of sources.
- Ability to interpret and present complex data to determine benefit-risk impact.
- Excellent verbal and written communication skills.
- Ability to interact effectively with stakeholders, including business partners.
- Ability to work in a matrix environment and demonstrate leadership.
- Ability to plan work to meet deadlines and manage multiple priorities effectively.
- Proficiency in Microsoft applications, including Word, Excel, and PowerPoint.
- Ability to influence, negotiate, and communicate with internal and external customers.
- Must already be authorized to work in the country of employment; immigration sponsorship is unavailable, and candidates on short-term status who require future sponsorship are ineligible.
Nice To Haves
- Advanced degree.
- Clinical experience.
- Medical writing or pharmacovigilance (PV) experience.
- Experience in cell therapy and/or oncology.
Responsibilities
- Lead safety evaluations, including strategy discussions with the Therapeutic Area Safety Head (TASH), Medical Safety Officer (MSO), and other stakeholders; data retrieval and analysis; report writing; and report revision.
- Ensure safety evaluations and reports are high quality and require minimal-to-moderate stakeholder comments and revisions.
- Support Associate Director Safety Analysis Scientists on novel projects without defined processes.
- Provide input to and review key regulatory or clinical documents as appropriate.
- Demonstrate leadership in the Safety Management Team (SMT) and support the MSO.
- Support SMT activities, including preparing and presenting data, compiling meeting minutes, and updating signal-tracking information.
- Lead proactive safety data reviews, when applicable, and form a safety position across Global Medical Safety that can be used for aggregate safety reports.
- Support written and verbal Health Authority interactions regarding safety and risk management.
- Contribute to cross-functional training of relevant stakeholders.
- Mentor other Safety Analysis Scientists on role-related activities.
- Participate in department and cross-functional initiatives and explore improved ways to present data, prepare reports, and increase efficiency.
- Assist in creating, reviewing, and implementing controlled documents and related tools.
- Support audits and inspections.
Benefits
- Consolidated retirement plan (pension) and 401(k) savings plan, subject to plan terms.
- Eligibility to participate in the long-term incentive program.
- Vacation: 120 hours per calendar year.
- Sick time: 40 hours per calendar year, with different stated amounts for employees residing in Colorado or Washington.
- Holiday pay, including floating holidays: 13 days per calendar year.
- Work, Personal and Family Time: up to 40 hours per calendar year.
- Parental leave: 480 hours within one year of a birth, adoption, or foster care placement.
- Bereavement leave: 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
- Caregiver leave: 80 hours in a 52-week rolling period.
- Volunteer leave: 32 hours per calendar year.
- Military spouse time off: 80 hours per calendar year.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
