Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients.
We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune disease. Our portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class.
Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of cancer and autoimmune indications.
We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization.
With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients.
Summary
The Pharmacovigilance Scientist (PVS) participates in the development and planning of safety strategies for assigned products in the clinical development and post-marketing. This will include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment. The PVS will play an essential role in developing PV/Safety documents in collaboration with other PV team members, and including cross-functional teams e.g., medical, clinical operations, regulatory affairs, Clin Pharm, and translational sciences.
Position Responsibilities
- Provide complete Cullinan product life-cycle support for assigned product(s) and participate in clinical study team meetings as appropriate for assigned products.
- May represent PV for assigned compounds on cross-functional teams, including Cullinan Safety Management Team (SMT), Independent Data Monitoring Committees (IDMC) and other teams with members external to Cullinan.
- Perform signal detection activities for assigned products in line with approved safety surveillance plan.
- Perform signal evaluation for any identified signals and author the safety evaluation report.
- Analyze the safety data, prepare and deliver presentations at SMT meetings.
- Alert the Head of PV and Medical Safety Physicians to potential safety issues recognized through single case medical review or aggregated data sets.
- Responsible for authoring, preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other stakeholder queries etc.
- Participate in other risk management/mitigation activities as appropriate for assigned compounds.
- Responsible for authoring the safety section in collaboration with team members on regulatory responses, IBs, Core safety Information (CSI)/Company Core Safety datasheet (CCDS), review Informed Consent Forms (ICF), CRFs, Data Monitoring Committees reports and requests, and other documents, and providing the necessary quality control.
- Participate and collaborate with Clinical/Medical function in the development of protocols, and ensure safety oversight in cooperation/leadership of the clinical trial medical team.
- Represent and actively participate in the preparation of clinical safety report (CSR) narrative writing and contribute to the review of the final CSR.
- Ensure timely, quality reports/safety analyses related to core deliverables with oversight as appropriate.
- Serve as a Pharmacovigilance resource to the cross-functional teams.
- Collaborate with clinical/Medical team to foster communication of the potential safety concerns.
- Able to work with and collaborate with Pharmacovigilance Operations (PVO) to manage PV related activities by CRO.
- Perform ongoing quality review of ICSR representing company review in accordance with study Safety Management Plans, Safety exchange agreements, and SOPs.
- Participate and collaborate with PVO for SAE reconciliation activities between the clinical and safety databases in accordance with SOPs.
- Participate and collaborate with PVO in the process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents.
- Review and provide input and support with other departments (e.g., clinical/medical, clinical operations, medical information, regulatory affairs, and data management) groups on PV-related topics for study protocols, statistical analysis plans, and other clinical-related documents.
Candidate Requirements
- MS, PhD, or PharmD.
- Previous safety or relevant experience in the pharmaceutical/biotech industry or health authority required, typically with at least 5 years of experience in PV/drug safety and risk management (preferably clinical development).
- Passion, dedication, and a can-do attitude to the career of PVS.
- Good written and verbal communication skills.
- Ability to utilize safety system database (Argus) for purposes of medical case review and simple queries.
- Knowledge of current and emerging regulatory requirements and expectations including EMA GVP Modules, FDA IND and NDA reporting requirements, global risk management requirements, ICH, CIOMS.
- Knowledge and experience in medical oncology and/or immunology is preferred.
- Ability to effectively present to cross-functional teams is required.
- Have led the authoring/preparation of aggregate safety reports (DSURs) for products to meet regulatory requirements.
Cullinan Therapeutics is proud to be an Equal Opportunity Employer. We are committed to creating an inclusive and diverse environment for all employees and applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
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