Clinical Safety Therapeutic Area HeadUnited States of AmericaR-0567992012 CSL Behring L.L.C.
The Clinical Safety TA Head will serve as the senior safety representative on the cross-functional development teams and post-marketing product teams. (S)He is responsible for setting safety strategy for these global projects and 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. The Clinical Safety TA Head will identify resources and tools necessary to facilitate safety surveillance and clinical safety assessment and to implement necessary risk management initiatives. In addition, the successful candidate will interface 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 decision–maker.
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 Clinical Safety TA Head serves as a member of the GCSP Leadership Team and Voting Member of the GSRT (Global Safety Review Team) for products within designated therapeutic area
Management of a Team of Clinical Safety Physicians / Senior Clinical Safety Physicians: Forms, aligns, empowers, and develops a global team of specialized clinical safety physicians / senior clinical safety physicians around a clear set of standards and strategic objectives. Directs the team of clinical safety physicians / senior clinical safety physicians across global sites with a high level of cultural diversity in a highly regulated environment. Trains and mentors clinical safety physicians / senior clinical safety physicians. Conducts workload management and resource planning for clinical safety physicians / senior 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 to protect ongoing study participants and complete timely communications to Health Authorities.
- 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 / senior 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 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 environment including many interface departments and functions.
- Clinical Safety Due Diligence Activities: Provides pharmacovigilance expertise and advice with regards to the selection of potential product acquisitions 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 and is transparent 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.
Chief Safety Officer
Clinical Safety Physicians and Senior Clinical Safety Physicians
- Minimum of MD (Medical Doctor degree) or international equivalent plus accredited residency.
- Accredited fellowship or clinical experience in relevant therapeutic area specialty is required.
- 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.
- Industry experience in designated therapeutic area(s).
- 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.
- Sound understanding of clinical medicine and strong clinical acumen with good ability to communicate on medical and scientific concepts.
- Demonstrated knowledge and understanding of drug development. Scientific expert who understands the complexities of pharmaceutical medicine and the delivery of healthcare.
- Clinical knowledge of therapeutic area patient populations and drug class.
- Expert knowledge of regulations and PV processes. Has mastery of global regulatory requirements for pharmacovigilance and drug safety.
- In-depth understanding of methods, tools, database systems and processes relating to signal detection, safety surveillance, clinical safety assessment, and risk management.
- Expertise in analyzing clinical trials from a safety perspective.
- Sound and balanced judgment; able to assess, manage, and communicate effectively with respect to the safety profile of medicinal products.
- Self-confident, proactive and decisive.
- High ethical standards as well as acknowledged personal credibility, the ability to gain trust at the senior executive level. Can speak forthrightly and is a role model, encouraging others to do the same. Possesses deep integrity and exhibits openness and transparency in all dealings within and outside line.
- Visible and credible advocate for patient safety with excellent communication skills (written and oral presentations) and demonstrated achievement in influencing and persuading others.
- Scientific leadership and visibility.
- Analytical and logical; is able to design and implement innovative improvement plans.
- Demonstrated leadership and ability in mentoring / coaching / directing safety physicians to be safety advocates, influencers, and leaders with capabilities in interpreting, analyzing and clearly presenting scientific and technical data (oral and written).
- Demonstrated ability to provide vision and strategic leadership within teams, internally cross-company, and externally with stakeholders.
- Able to work effectively and collaboratively across the organization with a focus on global multifunctional teams.
- Strong relationship builder, both internally and externally, including with international regulatory agencies.
- Role is located in KOP or MBG.
- Some domestic, regional and international travel is required.