Associate Director/Director of Drug Safety(Physician)
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Overview
Schedule
Full-time
Career level
Director
Remote
On-site
Compensation
$150,000-$250,000/year
Benefits
Health Insurance
Dental Insurance
Vision Insurance
Job Description
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.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.
- 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 exceeds 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.
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FAQs About Associate Director/Director of Drug Safety(Physician) Jobs at Systimmune
What is the work location for this position at Systimmune?
This job at Systimmune is located in Princeton, NJ, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Systimmune?
Candidates can expect a pay range of $150,000 and $250,000 per year.
What employment applies to this position at Systimmune?
Systimmune lists this role as a Full-time position.
What experience level is required for this role at Systimmune?
Systimmune is looking for a candidate with "Director" experience level.
What benefits are offered by Systimmune for this role?
Systimmune offers following benefits: Health Insurance, Dental Insurance, Vision Insurance, Disability Insurance, Paid Holidays, Paid Vacation, Paid Sick Leave, and 401k Matching/Retirement Savings for this position. Actual benefits may vary depending on the employer's policies and employment terms.
What is the process to apply for this position at Systimmune?
You can apply for this role at Systimmune either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.