CSL Behring Executive Director Clinical Pharmacology and Pharmacometrics in King of Prussia, Pennsylvania
With operations in 35+ nations and 27,000 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 (http://www.cslbehring.com) 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 (http://www.cslplasma.com/careers) , 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!
The global lead of Clinical Pharmacology and Pharmacometrics (CPP) is a key role to drive the evolving portfolio across the Plasma, Recombinant and Cell and Gene Therapy platforms. The role will oversee a high-functioning CPP team to ensure end to end deliverables, including Clinical and Translational Pharmacology plans, Pharmacometrics plans and aspects of Translational Science and Bioanalytical Assay plans. Key deliverables also include cross TA strategic and technical advisory, pharmacometrics, talent development, and matrix process optimization.
RESPONSIBILITIES AND ACCOUNTABILITIES
Enable a highly influential, strategy impacting voice for CPP globally, anticipating trends and strategic needs over a 3-5 year time period
Oversee the technical rigor and timely delivery of all translational and clinical pharmacology and pharmacometric study designs and data analyses supporting CSL and partner pipelines from pre-candidate selection into the marketplace
Ensure appropriate CPP involvement and leadership in submissions to and responses to questions from Health Authorities
Develop a sustainable, global talent pipeline for CPP, including strategic external hires and development of internal talent
Ensure CSL’s CPP methods are state of the art and utilize innovative quantitative approaches by leveraging external partnerships and maintaining deep networks and ambassadorship into technical communities of practice
Ensure resource and time efficiencies of Product Strategy Team (PST) deliverables through fostering of an agile, empowered operating model
Ensure appropriate CPP involvement and timely delivery of recommendations in corporate in-licensing and due diligence assessmentsEnsure sustainable and fit-for-purpose systems, processes and technologies are in place globally and cross functionally to ensure the above
Vice President Strategic Clinical Development
Sr Dir, Therapeutic Area Clinical Pharmacology Leads
Dir, Project Team Pharmacology
- PhD or PharmD/PhD with a clinical pharmacology related major (e.g. clinical pharmacology, pharmacokinetics, PKPD).
12+ years of of pharmaceutical industry (or relevant) experience, specifically leading and contributing to clinical pharmacology aspects of clinical drug development including success with regulatory submission and defense
Deep understanding of general clinical pharmacology principles (including the design and conduct of clinical trials), interpretation of PK, PK/PD, population PK methodologies and related data interpretation, and the use of biomarkers in clinical development, and development of strategic Clinical and Translational Pharmacology plans.
In-depth knowledge and experience in clinical pharmacology and pharmacometric components of regulatory submission
Experience in leading representation of clinical pharmacology/ pharmacometrics at critical submission-related regulatory authority meetings
Broad experience in the following clinical pharmacology deliverables/areas
IND, CTA, IB, Orphan drug applications, CTDs/submissions, regulatory agencies responses
ICH Good Clinical Practice and Good Laboratory Practice
Related EMA and FDA drug development guidelines
Quality Control systems and processes for data analytical work to meet Regulatory requirement
In-depth knowledge of and experience with global clinical pharmacology and pharmacometrics regulatory requirement
Excellent communication skills with demonstrated ability to effectively present any aspect of clinical pharmacology, as well as its plans/strategies, across various audiences in both verbal and written form.
Demonstrated success as a line manager and developer of people
Provide ability to lead matrix teams and influence across disciplines, including negotiation and influential skills.
Ability to independently present and defend clinical strategies to senior colleagues and governance committees
Established and excellent interpersonal skills, including a positive and constructive attitude and ability to work in a team matrix environment that fosters collaboration.
Worker Sub Type:
CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement