Senior Safety Physician at CatalYm

Planegg, Bavaria, Germany -

Full Time

Start Date

Immediate

Expiry Date

01 Sep, 26

Salary

0.0

Posted On

03 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Drug Safety, Safety Surveillance, Signal Detection, Risk Management Plans, DSURs, Medical Review, Safety Data Exchange Agreements, Regulatory Submissions, Trial Protocol Design, ICH Guidelines, FDA Safety Reporting, EU Safety Reporting, Oncology, Biologics, Patient Care, Quality Management System

Industry

Biotechnology Research

Description

Your mission In this role you will lead the strategic direction for Clinical Drug Safety, overseeing the evaluation of the safety profile of our products throughout their lifecycle. You will also shape and implement safety standards and drive the overall safety strategy supporting our clinical development programs. Responsibilities: Provide medical expertise and judgement in safety surveillance activities including periodic safety reports, safety signal detection, and in creation and updates of development risk management plans. Evaluate and manage risks associated with assigned projects and make recommendations for the management communication of risks, in accordance with global legal and regulatory frameworks. Lead the Signal Detection process for the CatalYm projects Provide Safety medical expertise and judgement in the production of high quality and timely Safety documents such as DSURs, Safety Summaries and Overviews for regulatory submissions. Perform the medical review of serious adverse event reports, including sponsor causality and expectedness assessment Implement and oversee the execution of Safety Data Exchange Agreements in projects where CatalYm is partnering in clinical development Provide medical Safety expertise to ensure high quality and timely responses to safety queries from all sources, including Regulatory Authorities. Provide medical expertise and judgement to Project Teams with respect to safety aspects of the design and preparation of trial protocols, investigators brochures, investigator letters and reports, for the follow up and processing of clinical trial data and lead the safety analyses of the assigned projects. Provide medical Safety input during development of relevant SOPs, working instructions, and guidelines. Owner of the CatalYm Safety System within the overall Quality Management System Your profile MD with several years of practical experience in patient care. More than 5 years of experience in clinical Safety with global trials in the pharmaceutical industry (preferably including biologics) Familiar with Safety relevant ICH Guidelines and ICHE6(R3) Familiar with EU and FDA Safety reporting requirements Fluent in English (writing and speaking) Based in Munich area with ca. 2 days per week in the office Why us? Contribute directly to the success of cutting-edge oncology programs. Be part of an agile, collaborative biotech environment with visible impact. Enjoy flexibility, ownership, and professional growth within a supportive culture. About us CatalYm is a biotech company based in Martinsried near Munich, developing innovative immunotherapies to transform cancer patients’ lives by effectively engaging their own immune systems to combat this malignant disease. We are now advancing to Phase 2b studies to confirm visugromab, our lead antibody, that has demonstrated durable anti-tumor efficacy with long-lasting objective responses in relapsed and refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. Our mission is to rapidly bring our next-generation immuno-oncology products to patients in need. Are you ready to board the fast-accelerating visugromab train in Martinsried? Then join us!

Responsibilities

Lead the strategic direction for Clinical Drug Safety and oversee the safety profile of products throughout their lifecycle. Provide medical expertise for safety surveillance, signal detection, and the creation of regulatory safety documents.