Associate Director, Safety Analysis Scientist
About The Position
We are searching for the best talent for an Associate Director, Safety Analysis Scientist, to be located in Spring House PA; Horsham, PA; Titusville, NJ; New Brunswick, NJ; Raritan, NJ; Princeton, NJ; Irvine, CA; San Diego, CA or Miami, FL. About Oncology Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine Purpose: The Associate Director (AD) Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned assets for Johnson & Johnson Enterprise Innovation. In partnership with the Senior Safety Officer (SSO), this role is responsible for the preparation of scientific safety analysis and evaluations, which are required for regulatory compliance and to aid in safety-related decisions for assets throughout their lifecycle. The AD SAS will support product Safety Management Teams (SMTs) and work in close collaboration with other cross-functional and cross-sector partners, including Pharmaceutical and MedTech safety, to determine an asset’s safety strategy, complete safety analyses and evaluations, proactively review safety data/lead safety data review meetings and interpret safety information to make a recommendation, supporting SMT deliverables as required. This position will assist the SSO with activities related to the SMT and with contributions to key safety and clinical documents. As an asset point of contact, The AD SAS will have in-depth asset knowledge, and will provide training to, and oversight of deliverables prepared by, other team members as needed (for complex reports). Functioning with a high level of independence and with minimal guidance from the SSO, this role will be able to link discussions to content, and consistently deliver high quality results with minimal guidance. The AD SAS will quickly build alliances and be able to independently influence other partners to shape strong safety decisions/outcomes.
Requirements
- Bachelor's degree in a healthcare or biomedical science discipline and 11+ years of industry experience required.
- Working knowledge of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements required.
- Ability to understand and analyze complex medical-scientific data from a broad range of disciplines required.
- Ability to interpret and present complex data to determine benefit-risk impact required.
- Excellent English verbal and written communication skills required.
- Ability to effectively interact with stakeholders, including business partners required.
- Ability to work in a matrix environment, proven leadership skills required.
- Ability to plan work to meet deadlines and effectively handle multiple priorities required.
- Proficiency in Microsoft applications (e.g. Word, Excel, and PowerPoint) required.
- Ability to independently influence, negotiate and communicate with both internal and external customers required.
Nice To Haves
- Master's degree in a healthcare or biomedical science discipline and 8+ years of experience or a PharmD/PhD in a healthcare or biomedical science discipline and 5+ years experience preferred.
- Medical writing or PV experience required.
- Clinical experience preferred.
Responsibilities
- Lead proactive safety data reviews, if applicable and form a safety position across JJEI which can be leveraged for aggregate safety reports.
- Support SMT activities (e.g. preparing and presenting data, compiling meeting minutes, updating signal tracking information).
- Demonstrate leadership in the SMT and support the SSO.
- Drive safety evaluations including risk-benefit discussions, collaborating with SSO and other stakeholders as necessary, data retrieval, data analysis, report writing, and report revision.
- Provide input and review to key regulatory or clinical documents as appropriate.
- Assume responsibility for novel projects, create value and innovate without defined processes.
- May seek guidance from senior leadership (i.e SSO, Chief Safety Officer (CSO) for complex projects.
- Lead cross-functional training of relevant stakeholders.
- Act as safety database querying Subject Matter Expert (SME) for audits/inspections.
- Participate in, or lead, department and/or cross-functional initiatives.
- Explore innovative ways of presenting data, preparing reports, and improving efficiencies within the programs they own.
- Assist SSO and operational leads in the creation, review and implementation of controlled documents and other related tools.
- Management of unscheduled reports within the Aggregate Report Calendar.
- Liaison activities within pharmaceutical and medical technology sectors, as applicable.
- Line-management of contractor positions within the team, as applicable.
- Oversight of deliverables by other team members (e.g. complex reports), as needed
Benefits
- Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- 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 the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period10 days
- 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
Mid Level
