Associate Director, Safety Analysis Scientist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

About Innovative Medicine

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. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

About Oncology

Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities for 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.

This role is available in Raritan, NJ; Titusville, NJ; or Horsham, PA. This is a hybrid position that requires you to be on site three days a week.

Purpose

The Associate Director (AD) Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products. The AD SAS, in partnership with the Medical Safety Officer (MSO), 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 marketed products and products in development. The AD SAS will support product Safety Management Teams (SMTs) and work in close collaboration with other cross-functional safety partners to determine a product’s safety strategy, complete safety analyses and evaluations, proactively review safety data/lead safety data review meetings, and interpret safety information to make recommendations. The role involves supporting SMT deliverables, assisting the MSO with SMT activities, and contributing to key safety and clinical documents.

Responsibilities

• Lead safety evaluations including strategy discussions, collaborating with Therapeutic Area Safety Head (TASH)/MSO and other stakeholders as necessary, data retrieval, data analysis, report writing, and report revision.
• Ensure high-quality safety evaluations and reports with minimal comments from stakeholders and minimal revisions required.
• Provide input and review of key regulatory or clinical documents as appropriate.
• Demonstrate leadership in the SMT and support the MSO.
• Support SMT activities (e.g., preparing and presenting data, compiling meeting minutes, updating signal tracking information).
• Lead proactive safety data reviews, if applicable, and form a safety position across Global Medical Safety (GMS) which can be leveraged for aggregate safety reports.
• Provide support for Health Authority interactions regarding safety and risk management, both written and verbal.
• Assume responsibility for novel projects, create value, and innovate without defined processes. May seek guidance from Directors (i.e., SAS TAL) for complex projects.
• Lead cross-functional training of relevant stakeholders.
• Act as product or process 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 Directors in the creation, review, and implementation of controlled documents and other related tools.
• Manage unscheduled reports within the Aggregate Report Calendar.
• Handle management activities within smaller Therapeutic Areas, as applicable.
• Line-management of contractor positions within the team, as applicable.
• Act as backup to TAL as needed (e.g., Director SAS TAL is unavailable).
• Provide oversight of deliverables by other team members (e.g., complex reports), as needed.

Requirements

• Bachelor’s Degree Required: Healthcare-related or Biomedical Science (11+ years industry experience or equivalent).
• Advanced Degree Preferred: Healthcare-related or Biomedical Science (8+ years industry experience or equivalent).
• Medical writing or Pharmacovigilance (PV) experience required.
• Working knowledge of medical concepts and familiarity with safety activities in drug development and post-marketing and global safety health authority requirements.
• Ability to understand and analyze complex medical-scientific data from a broad range of disciplines.
• Ability to interpret and present complex data to determine benefit-risk impact.
• Excellent English verbal and written communication skills.
• Ability to effectively interact with stakeholders, including business partners.
• Ability to work in a matrix environment, proven leadership skills.
• Ability to plan work to meet deadlines and effectively handle multiple priorities.
• Proficiency in Microsoft applications (e.g., Word, Excel, and PowerPoint).
• Ability to independently influence, negotiate, and communicate with both internal and external customers.

Qualifications

• Clinical experience preferred.
• Oncology experience preferred.

Pay

The anticipated base pay range for this position in the US is $137,000 to $235,750. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. Bonuses are awarded at the Company’s discretion on an individual basis.

Benefits

• Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Participation in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Vacation – up to 120 hours per calendar year.
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year.
• Holiday pay, including Floating Holidays – up to 13 days per calendar year.
• Work, Personal and Family Time - up to 40 hours per calendar year.