Clinical Research – Global Clinical Therapeutic Area Head, Cardiovascular & Metabolism
The Global Clinical Therapeutic Head is responsible for providing innovative scientific and medical leadership in defining the global development strategy for assigned clinical programs within Clinical Research. The incumbent will have responsibility for strategic clinical development planning; ensuring collaboration with key internal stakeholders to deliver successful license applications and product life cycle management aligned with Commercial Operations strategies and the regulatory environment. He/she will oversee the activities of assigned (Senior) Clinical Program Directors/ Scientists within his/her Therapeutic Area.(Cardiovascular & Metabolism)
• Provide tactical and strategic medical leadership and guidance to the global clinical development activities supporting new registrations and life cycle management of CSL therapeutic compounds, ensuring alignment with commercial strategies and compliance with regulatory guidance where relevant.
• Ensure that the overall scientific and medical content of all clinical programs is sound, is supported by high value data driven decision-strategies and is documented through program specific Clinical Development Plans.
•Anticipate and address future potential clinical development needs and opportunities, based on the clinical character of the compound, evolution of the regulatory and commercial competitive environment.
•Determines the overall risk-benefit assessment through securing cross functional alignment and / or transparent discussion of risks and benefit pertinent to the clinical program and ensure with relevant department heads/ delegates that clear plans to investigate, manage and track risk through the clinical program are reflected in the clinical development plan.
•Develop and maintain relationships with Research, Pre-clinical Research and Translational Medicine to facilitate the integration of pre-clinical, non-clinical and translational science findings within clinical program planning.
•Ensure clinical development planning and strategies are updated for stage gate evaluations and present, as required, clinical development strategies and overall benefit-risk evaluations, pertaining to the assigned therapeutic area, to senior review committees such as CR&D Review Committees, Global Clinical Safety Committee, Project Review Committee, Project Steering Groups.
•Act as an internal clinical therapeutic expert developing and maintaining an understanding of key disease states/etiology, treatments, therapeutic trends, competitive agents for the indications and development projects within the assigned therapeutic area.
•Establish the presence and reputation of the company through thought leadership, interactions with KOLs in fundamental issues affecting the therapeutic area and contribute to the advancement of the company.
•Develop and sustain strong professional relationships with regulatory authorities and represent the company, as required, at key regulatory review forums e.g. pre-IND/EMA Scientific Advice; post Phase II, regulatory advisory committee meetings.
Requirements:
Education & Experience:
•Advanced degree (MD, PhD or PharmD) in life science/healthcare required. Board Certified (or non-USA equivalent) in Internal medicine or relevant sub-specialty highly preferred
•Clinical development experience leading a therapeutic area or complex clinical program with a working knowledge of pharmaceutical and regulatory development processes is essential.
•A minimum of 10 years experience preferred, acquired in either industry or academic positions, although the latter would also require experience in working with industry sponsors.
CSL Behring LLC will provide equal employment opportunity for all persons without discrimination on the basis of membership in a legally protected class, including race, color, religion, national origin, gender, age, veteran status, or handicap/disability.
CSL Behring is committed to ensuring that diversity and inclusion are a part of our everyday business.
Worker Type:
Employee
Worker Sub Type:
Executive
