Director, Clinical Safety Physician

About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Job Overview

To provide guidance and expertise on all aspects of clinical safety throughout the entire lifecycle of a product with special emphasis on ongoing evaluation of safety information during clinical development and state of the art pharmacovigilance post approval. Apply sound medical judgment for analysis and interpretation of complex clinical safety data for signal detection and initiation of safety risk management activities including safety specification, PV planning and risk minimization/mitigation. Integrate safety risk management activities of the product into their medical, business and regulatory context.

Responsibilities

o Lead active monitoring and continued assessment of safety profile through systematic signal detection and critical review of aggregate safety data and literature during all phases of the life-cycle of a defined portfolio of medicinal products.

o Guide the clinical development teams regarding all aspects of clinical safety, including trial design, appropriateness of safety endpoints, analysis and interpretation of safety data.

o Liaise with KOLs, set up and coordinate Advisory Boards and Drug Safety Monitoring Boards. Be accountable for timely delivery of all safety deliverables towards Clinical Study Reports, preparations for market applications and all other regulatory documents.

o Lead multidisciplinary teams (e.g. Safety Management Teams) regarding safety relevant topics and escalate all safety relevant matters to the appropriate decision making level with proposals for solutions based on analysis of the available information.

o Act as safety expert providing strategic input to key stake holders in relation to product safety, understand the business strategy for the product and be knowledgeable about the (medical) context of the respective product class.

o Be the accountable content owner for all safety relevant content or safety relevant safety documents during clinical development (e.g. DSUR, Development Risk Management Plans, Safety Analysis Plans) and post approval (e.g. PSUR, RMPs, medical expert statements and answers to HAs requests). Be content owner for safety relevant communications such as DHCP letters and company statements.

o Perform investigation into safety profile of potential new product acquisitions (due diligence processes) and ensure that all necessary requirements are included in PV agreements, and also act as safety liaison to license partners.

o Participate actively in the Continuous Improvement Process (CIP) targeted at continuous improvements of quality of processes, methods and communication.

o Review and contribute to safety relevant SOP and improvement of safety relevant SOPs.

o Develop and update of safety relevant chapters of the CCSI/DCSC including frequency tables for ADRs and justification documents for new safety information.

o Interface with other departments (e.g. clinical development, regulatory, health economics, pharmacy-epidemiology, medical affairs) with regard to safety aspects.

o Be subject matter expert for safety relevant discussions with regulatory agencies and other significant external bodies.

o Provide expert advice (expert witness as required) to legal counsel regarding safety issues, as well as safety expertise to project teams

o Contribute to clinical safety risk management relevant training and mentoring.

o Analyze and prepare safety data for manuscript and/or publication submissions.

o Contribute to quality improvement: Review, prepare, and/or update local and global SOPs and working instructions as required.

Requirements

• Minimum of MD (Medical degree) or international equivalent plus accredited residency.

• Two (2) years minimum experience as a physician in patient care.

• 3 + years pharmaceutical / biotechnology industry experience, with 1 including accountability for medical oversight/evaluation or clinical development.

• Industry experience in designated therapeutic area(s).

• Experience and success in addressing and managing complex medical issues in the pre-approval and post-approval environment.