Join to apply for the Associate Director of Drug Safety role at SystImmune Join to apply for the Associate Director of Drug Safety role at SystImmune SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.

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This individual is to lead medical assessment and interpretation of safety data from multiple sources, including clinical trials, and literature reports. The individual will be closely collaborating with cross functional teams in supporting all clinical development programs, regulatory filling, and global safety related activities. This individual will also support the clinical R&D team in the oversight of PV service vendors and partners and will need to maintain medical knowledge, as well as current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.

This role requires a full-time onsite presence at our Princeton, NJ location.

Responsibilities

Provide medical safety input and participate in safety surveillance activities (e.g., identification of safety signals and ensure timely assessment and communication of confirmed safety signals). Provide input in the generation of aggregate safety reports (e.g., DSURs, PADER, PBRER). Serve as a leading medical safety resource for the development and review of clinical trial protocols, informed consent forms (ICFs), investigator brochures (IBs) and Reference Safety Information (RSI). Collaborate with Medical Monitors and Clinical Research Scientists and vendor clinical staff as needed for ongoing clinical trials. Provide medical safety input in the development and/or updates of Risk Management Plans and the maintenance of these documents. Provide support and input to the development of Standard Operating Procedures, Working Instructions, and other guidance documents. Serve as a subject matter expert for vendors that provide drug safety and pharmacovigilance services. Work closely with other Product Safety Leads to respond to and resolve safety questions from health authorities as well as regulatory agency’s audits and inspections

Qualifications

5+ years’ experience in Drug Safety/Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency. Medical Degree (MD) from a recognized medical school with medical practice experience. Oncology / Hematology experience strongly preferred Strong working knowledge of US and EU drug safety and pharmacovigilance regulations, CIOMS and ICH guidelines. Proven experience in medical safety assessments, safety surveillance and risk management activities Proficiency with medical review of ICSRs, including expectedness assessments, causality assessments, narrative review and generation of Analysis of Similar Event and company comment statements, including benefit-risk assessment. Experience with preparation of aggregate reports (e.g., DSUR, PSUR/PBRER, PADER) Experience in preparation of responses to regulatory authorities; experience with regulatory filing and related activities preferred

Compensation and Benefits:

The expected base salary range for this position is $150,000 - $250,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills.

While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise align strongly with the requirements of the role.

SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.

We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.

SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.Seniority level Seniority levelMid-Senior level Employment type Employment typeFull-time Job function Job functionBusiness Development and Sales IndustriesInternet Publishing Referrals increase your chances of interviewing at SystImmune by 2x Sign in to set job alerts for “Associate Director” roles.Assistant Director, Strategic Operations New Jersey, United States $81,850.00-$106,400.00 1 month ago Assistant Manager/Assistant Director/Fitness Director/ PT Director Watchung, NJ $12,000.00-$49,500.00 2 weeks ago Raritan, NJ $187,989.00-$246,735.00 2 weeks ago Associate Director of The Lawrenceville FundAssociate Director, Consumer Insights, VINCI New Jersey, United States $137,000.00-$226,500.00 2 weeks ago Princeton, NJ $210,000.00-$285,000.00 1 week ago Associate Director, US Medical, Cell TherapyBusiness Development Roles - East Coast (Associate Director to Director)Senior Manager, Championship Communications Bedminster, NJ $95,000.00-$105,000.00 1 week ago Senior Director/Director of Study Start-up Princeton, NJ $180,000.00-$220,000.00 2 weeks ago Associate Director, Commercial Operations, 3PL & Distribution PartnersAssociate Director to Senior Director, Clinical Research - Oncology New Jersey, United States $230,000.00-$340,000.00 1 week ago Executive Director, Project Management (Design and Construction) Princeton, NJ $243,000.00-$274,000.00 1 week ago Plainsboro, NJ $148,290.00-$259,510.00 5 days ago Associate Director of Strategic Accounts Rheumatology & Dermatology - NortheastAssociate Director, Continuous Improvement and Molding Excellence Princeton, NJ $175,000.00-$195,000.00 2 weeks ago Princeton, NJ $221,000.00-$277,000.00 6 hours ago Associate Director, US Medical Oncology, Targeted Therapies (NSCLC)Assistant director of Operations - We Are GrowingAssociate Director of Regulatory AffairsAssociate Director, Translational Medicine , Late Stage NeuroscienceAssociate Director, Regional Marketing & Product Management, Catalog Products Piscataway, NJ $90,000.00-$140,000.00 2 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

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