VP Global Clinical Safety & Pharmacovigilance

Employer
CSL Behring
Location
King of Prussia, Pennsylvania
Posted
Sep 11, 2020
Ref
R-121448
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
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

Position Overview

The Vice President of Global Safety and Pharmacovigilance (PV) will be responsible for the strategic direction related to safety and PV teams, leading a department of 140 professionals, and identifying and achieving creative and efficient solutions for CSL Behring. S/he will provide strong leadership and partner with cross functional teams to continue to transform the safety and PV functions into an organization that adds value for CSL and is positioned for future portfolio growth and future innovation. In partnership with the CMO and other R&D colleagues, the Vice President will consciously bring internal voice of the patient in alignment with CSL's corporate social responsibility.

Primary Responsibilities
  • Provide strategic planning, development and evaluation concerning all safety and pharmacovigilance aspects across CSL Behring's entire portfolio of projects, regardless of stage of development or platform (plasma, antibodies, recombinant proteins, cell & gene therapy)
  • Provide clear direction and strong leadership to the Global Safety and Pharmacovigilance department to develop the function, safeguard patient safety and support the business objectives
  • Be an active cross-functional member of the R&D leadership team, helping to set strategy, focus, and priorities and contribute to decision making.
  • Leadership of the Global Safety Committee
  • Membership on key internal governance such as the Global Benefit: Risk Committee and First in Human Committee and external committees such as our Bioethics Advisory Board
  • Active responsibility for growth and development of R&D personnel within Safety and across R&D
  • Motivate and lead the Safety and PV team that effectively supports the business by hiring, developing and retaining qualified staff.
  • Work closely with the Commercial organization and Quality organization to ensuring an integrated approach to product quality and safety worldwide
  • Promote the organization through active participation in memberships and presentation in industry committees, meetings, and conferences.
  • Develop and implement the strategic plan to meet the current and future needs of the company, ensuring that the infrastructure, policies, processes, personnel and ways of working (including technology applications) are responsive to the needs of the company's growth and objectives.
  • Provide strategy and PV expertise with regards to due diligence on potential in-licensing deals.
  • Support the organization's objectives overall, while ensuring that staff are equipped to achieve success in terms of cycle time metrics, retention rates, and productivity improvements.
  • Provide guidance for the development of safety and PV strategies within CSL and in development and execution of client goals.
  • Support PV operations to establish and maintain policies and procedures for the business.
  • Direct and oversee all activities with focus on data quality, completeness and transparency while considering patients anonymity. Provide advice and consultation on safety data management or functional area-specific activities to both internal and external investigators and partners.
  • Ensure ongoing evaluation of the safety profiles and work in partnership with internal and external stakeholders to bring potential safety issues to the attention of the organization. Assist the Chief Medical Officer in creating an annual Safety report for the Board.
  • Provide input and review of responses to regulatory agency questions with regard to safety and PV activities.
  • Ensure ongoing evaluation of industry changes regarding regulations and technology advancements to implement best practices and meet or exceed industry standards.


Professional Experience and Requirements
  • MD is required; experience working in Rare Disease, Gene Therapy, Hemophilia would be ideal but not required. Should have at least some experience working with biologics
  • 15 to 20 years' experience in safety and PV, along with 10 years' experience and demonstrated success and progressive responsibility in leadership positions.
  • Experience managing a minimum of 50 people globally. Demonstrated success in growth and development of more junior staff.
  • Direct involvement in a product recall, large safety post-marketing commitment, risk minimization and mitigation program(s), cessation of development project for safety issue, or similar high-profile issue is ideal but not mandatory.
  • Proven business and market knowledge (i.e., understanding stakeholder needs regarding business environments and developing strategies to maximize value to the organization).
  • Must be considered as a recognized leader within the safety and PV space.
  • Exceptional people and thought leadership skills, with the ability to think strategically and influence others.
  • Experience, knowledge and understanding of scientific and regulatory requirements for medicinal and combination products authorized to be marketed.
  • Experience and knowledge of PV and other legislations relevant for the post marketing phase as well as global development requirements in clinical safety and PV (U.S., Europe, Asia Pac, etc.). Experience in Health Authority interactions desirable.
  • Ability to effectively work cross culturally and build strong relationships. Understand and successfully manage culture-driven differences in risk analysis, decision making, and team interactions.
  • Proven track record of innovation and finding creative approaches in medical safety and PV strategy, implementation, and execution.
  • Proven strategic resource management experience (i.e., applying strategic planning, deployment and utilization of resources and technology to effectively fulfill the organization's/ department's mission).
  • In depth knowledge and ability to apply GCP/ ICH and applicable regulatory guidelines.
  • Strong leadership skills including negotiation and influencing skills as well as executive gravitas is required.