Senior Global Program Director

CSL

About The Position

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/. At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

Requirements

Minimum of MD (Medical Doctor degree) or international equivalent plus accredited residency.
Two (2) years minimum experience as a physician in patient care.
5 + years pharmaceutical / biotechnology industry experience, with 2 of which include 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.

Responsibilities

Global responsibility for medical oversight of selected pipeline and/or products within the assigned therapeutic area(s).
Ensures medical standards and processes are in alignment with expectations of manufacturers by internal and external stakeholders including regulators, governmental agencies, payors, physicians, patients and the general public.
Serves as a senior medical representative on the cross-functional therapeutic area, development teams and/or post-marketing product teams.
Responsible for setting technical medical strategies for global projects and therapeutic areas, consistent with functional expectations.
Identifies potential challenges, risks and roadblocks associated with the global medical strategy and works as a leader in developing solutions to address these, working cross-functionally and inter functionally with other departments.
Identifies resources and tools necessary to facilitate risks and to implement necessary risk management initiatives.
Interfaces with key high-level internal and external stakeholders, contributes to, and approves regulatory reports / submissions / queries.