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Clinical Safety Therapeutic Area Head, Cardiovascular & Metabolic

Company: CSL Behring
Location: King Of Prussia
Posted on: January 17, 2020

Job Description:

About CSL

With operations in 35+ nations and - 22,000 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 the second largest influenza vaccine company 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

Located within CSLB's GCSP department, the Clinical Safety Therapeutic Area Head has global responsibility for safety oversight of all new and marketed products in CSLB's Cardiovascular & Metabolic portfolio within the assigned therapeutic area(s). The role serves as the senior safety representative providing deep therapeutic area (Cardiovascular & Metabolic) medical and scientific knowledge in the cross-functional development teams and post-marketing product teams. It is responsible for setting safety strategy for these global projects. The role identifies potential challenges, risks and roadblocks associated with the global safety domain and works as a leader in developing solutions to address these, working cross-functionally across GCSP and interfunctionally with other departments. Strong therapeutic area knowledge and deep experience in managing the complex safety issues of biologicals are needed for success in the role. The role ensures that the medical and process standards delivered in CSLB are in alignment with the following safety objectives expected of manufacturers by internal and external stakeholders including regulators, governmental agencies, payors, physicians, patients and the general public:
--- Complying with legal requirements and company standards of the PV (Pharmacovigilance) tasks and responsibilities.
--- Preventing harm from adverse reactions in humans arising from the use of authorized medicinal products within or outside the terms of the market authorization or from occupational exposure.
--- Promoting the safe and effective use of medicinal products in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public.
--- Contributing to the protection of patients and public health. The role manages a staff of clinical safety physicians who are assigned to global development projects and post-marketing product teams in Cardiovascular & Metabolic. The Cardiovascular & Metabolic portfolio matches with those of the company new Cardiovascular & Metabolic TALT structure and will include oversight of the following products: CSL112 CSL346. The role identifies resources and tools necessary to facilitate safety surveillance and clinical safety assessment and to implement necessary risk management initiatives. The role interfaces with key high-level internal and external stakeholders, contributes to, and approves regulatory reports / submissions / queries. He / she independently addresses the most complex safety issues as a key decisionmaker. The role provides strategic input into clinical development, due diligence, regulatory and issue management activities from a clinical safety perspective and represents the position of GCSP in internal governance committees and in discussions with Health Authorities. The role serves as a member of the GCSP Leadership Team and Standing Member of the GSC (Global Safety Committee) providing an independent TA Head vote for products outside TA.

  • Management of a Team of Clinical Safety Physicians: Forms, aligns, empowers, and develops a global team of specialized clinical safety physicians around a clear set of standards and strategic objectives. Directs the team of clinical safety physicians across global sites with a high level of cultural diversity in a highly regulated environment. Trains and mentors clinical safety physicians. Conducts workload management and resource planning for clinical safety physicians' assignment to global development teams, post-marketing product teams and projects. Makes sure that team has completed required PV training to meet compliance needs.
  • Safety Surveillance and Risk Management: Oversees safety management teams ensuring a thorough and consistent approach to the review of safety data emerging from clinical trials and from the post-marketing environment. Oversees the safety signal detection and medical signal evaluation process. Oversees analysis of aggregate safety data and the production of key company documents such as DSURs (Development Safety Update Reports), PSURs (Periodic Safety Update Reports) and risk management plans relating to the safety of medicinal products, which are subject to regulatory review and discussion. Provides a safety role in facilitating reviews done by internal and external DMCs (Data Monitoring Committees) and in unblinding clinical data with Chief Safety Officer approval to protect ongoing study participants and complete timely communications to Health Authorities. Supports the development of safety materials for FIH presentations at GSC following SMT review.
  • Quality Management: Oversees quality of all clinical safety document deliverables. Ensures timely production of aggregate reports and answers to queries from Health Authorities according to consistent quality standards. Reviews performance and processes against defined targets / KPls (Key Performance Indicators) and takes corrective actions as necessary. Ensures that processes, tools and systems are continuously improved.
  • Regulatory Agency Requests: Responsible for timely and concise responses to Regulatory Agency requests relating to patient safety.
  • Inspections: Ensures regulatory agency inspection findings and internal audit findings relating to areas of responsibility are addressed and resultant Corrective Action Plans (CAPA plans) are implemented efficiently and effectively in the function. Makes certain clinical safety physician SMEs (Subject Matter Experts) are well prepared for participation in inspection interviews.
  • Clinical Safety Development of the CSLB portfolio: Sets safety strategy based on strong therapeutic area knowledge and biologicals safety experience that allows for successful IND (Investigational New Drug) / NDA (New Drug Application) filings and initiation of first in human studies. Oversees all processes that lead to the production of safety sections and content of relevant clinical trial documents including protocols, investigator brochures, informed consent forms, clinical study reports. Oversees development of core safety information for new products. Sets the strategy, reviews and approves key filing documents including ISS, SCS, and risk management plans. Provides major contributions to current and potential safety issues, being proactive in addressing safety issues and setting up any additional systems to mitigate risk in CSLB's studies. Gives guidance on various medical, product-related and process-related matters in a complex medical and scientific environment including many interface departments and functions.
  • Clinical Safety Due Diligence Activities: Provides pharmacovigilance expertise and medical / scientific advice with regards to the selection of potential product acquisitions in Cardiovascular & Metabolic through the due diligence process and provides strategic input in license agreements. Works to ensure additions to the CSLB portfolio have a promising benefit-risk profile based upon medical and scientific evaluation and that there is transparency internally with respect to potential benefit-risk issues.
  • Clinical Safety Representation: Represents global clinical safety in CSLB safety governance committees. Collaborates with other functions and stakeholders, such as clinical, regulatory, medical and other functions to increase the overall profile of GCSP. Represents GCSP in relevant therapeutic area forums, both internal and external. Acts as delegate / deputy for Chief Safety Officer for therapeutic area(s) as assigned.Education:
    • Minimum of MD (Medical Doctor degree) or international equivalent plus accredited residency.
    • Accredited fellowship or clinical experience in relevant therapeutic area specialty is required.Experience:
      • Two (2) years minimum working experience as a physician in patient care.
      • Ten (10) years pharmaceutical / biotechnology industry experience, of which at least five (5) should be in a safety role, with broad overview of all aspects of a PV system and specific experience in signal detection and risk management.
      • Strong industry experience in designated Therapeutic Area of Cardiovascular & Metabolic including the safety management of biological molecules.
      • Previous line/matrix management experience and a record of accomplishments in managing and developing people.
      • Experience and success in addressing and managing complex safety issues in the pre-approval and post-approval environment.Technical Competencies
        ..... click apply for full job details

Keywords: CSL Behring, Philadelphia , Clinical Safety Therapeutic Area Head, Cardiovascular & Metabolic, Healthcare , King Of Prussia, Pennsylvania

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