With operations in 35+ nations and ~ 25,000 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.
The Global Clinical Program Director (CPD) is a key role within Clinical Development responsible for global implementation of clinical development plans for assigned products/ therapeutic areas. The position provides innovative scientific and operational leadership to translate CRD strategies products into patient benefit through the safe, efficient and timely execution of assigned clinical programs. The CPD will contribute to study design and the development of trial related documents, is responsible for medical oversight of clinical trials and will contribute to the medical/scientific analysis and interpretation of clinical data and the writing of clinical study reports and regulatory submission documents. In addition, the CPD is a key member of clinical development/ operational and safety/risk management teams for assigned products.
- Responsible for concept development and design of clinical trials and contributes to the integration of clinical strategy into the overall clinical development plan.
- Participate in or lead a matrixed clinical development team, responsible for the generation and maintenance of a scientifically sound clinical development plan aligned with regulatory and commercial strategies and act as the primary clinical strategy representative on the core project team and on safety/ risk management teams.
- Responsible for clinical development aspects of project planning, protocol concept development and clinical trial design, generation of study synopses, and assessment of clinical study results. Provide medical review for study relevant documents such as protocols, clinical study reports, Investigator Brochures and review study specific plans covering aspects such as data coding conventions and data reconciliation procedures, statistical analysis plans and informed consent documents, and provide review of final study reports. Responsible for study specific medical responsibility plans to document medical monitoring activities (CSL versus CRO) required for a specific study.
- Contribute to the writing of clinical components of regulatory dossiers through authoring key clinical sections and by providing oversight to contributions from clinical scientists as relevant. Provide advice on the clinical aspects of regulatory strategy in support of the filing of INDs/CTAs and license applications throughout the development lifecycle. Lead/ contribute to the preparation of clinical sections for regulatory meetings and attend and present at such meetings (e.g. pre-IND or end Phase II meetings/ Scientific Advice/ Advisory Boards) where required.
- In collaboration with commercial development and clinical operations identify key opinion key investigators. Develop and maintain relationships with lead investigators within assigned therapeutic area. Additionally participate and/or present at investigator meetings.
- Act as Medical Monitor serving as the physician contact for an Investigator site and providing medical expertise for answering specific inclusion/exclusion criteria questions and resolving study related issues. Accountable for overall medical and safety decision making at the study level. Lead the medical review for data monitoring committees and end point adjudication boards as required.
- Contribute to the identification of and assist in providing direction to clinical consultants. Contribute to Scientific Advisory Board activities to support clinical development strategy and discussion.
- 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.
- Actively participate in Commercial Development activities by contributing to publication planning, Clin Comm. reviews and Global Business Teams to ensure close collaboration with Commercial Development and Medical Affairs.
- Contribute to the development of Clinical Scientists through active participation in training and mentoring activities.
MD - Board Certified (or non-USA equivalent) in Internal medicine or relevant sub-specialty preferred. Clinical development experience with a working knowledge of pharmaceutical and regulatory development processes is essential. This could have been acquired in either industry or academic positions, although the latter would also require experience in working with industry sponsors.
About this company
CSL Behring is a global biotechnology leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company’s products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic disease of the newborn.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs more than 25,000 people, and delivers its life-saving therapies to people in more than 60 countries.
Location/Region: King of Prussia, PA