Director Clinical Pharmacology

3 days ago

King of Prussia Pennsylvania, Montgomery County, PA, United States CSL Behring Full time

CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.

With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired 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, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.

Could you be our next Director Clinical Pharmacology? This position is located in our King of Prussia PA office. It is a Hybrid role. You will report to the Executive Director, Clinical Pharmacology .

You are responsible for clinical pharmacology matters for a range of projects spanning the CSL R&D portfolio. You will be independent in a matrix team-aligned in the fulfillment of Clinical Pharmacology responsibilities. This includes leading a program's clinical pharmacology & pharmacometrics strategy, ensuring coverage and integrated delivery of all pharmacokinetic and modeling and simulation aspects, and the design of clinical pharmacology studies for multiple programs. Also, your role will involve important written/oral ClinPharm/ Pharmacometric interactions with regulatory authorities, writing of clinical pharmacology sections in the dossiers and answering questions in connection with submission procedures.

Main Responsibilities and Accountabilities

  • Lead, with a high degree of independence, the clinical pharmacology and PK-PD strategy for portfolio programs, working together with the Pharmacometrician, Clinical Program Director, Clinical scientists, Biostatisticians, and other CDT colleagues.
  • Lead the design of clinical pharmacology studies or protocol sections throughout all stages of drug development and provide oversight for implementation of such studies together with Clinical Development, Clinical Safety and Clinical Research Operations.
  • Plan and implement relevant PK-PD analyses, including non-compartmental analysis of PK data and PK-PD analysis.
  • Lead the high-quality review and interpretation of clinical pharmacology study results and oversee the presentation and writing thereof in clinical study reports, publications and related study documentation.
  • Independently provide clinical pharmacology & pharmacometrics representation on clinical development matrix teams, ensuring agreement and integration of the clinical pharmacology strategy within the global development plan.
  • Independently implement the use of analytical methods such as pharmacometrics/modeling & simulation to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to support study designs, throughout an assigned clinical development program.
  • Provide clinical pharmacology contributions to protocols, regulatory documents including Investigator Brochures, Submissions, Labeling and those required for face-to-face attendance at regulatory meetings and regulatory filings. Provide resolution of clinical pharmacology queries from regulatory agencies, taking a lead role in setting strategy to and writing responses.
  • Provide support to Research and Translational Science and in the development of preclinical PK-PD knowledge required for early clinical development strategy and using Pharm-Tox data in the development of early clinical studies.

Position Qualifications and Experience Requirements

  • PhD or PharmD. Clinical pharmacology research fellowship favorable and experience in a clinical pharmacology discipline (e.g., PK-PD).
  • 10+ years experience specifically contributing to the clinical pharmacology aspects of clinical drug development.
  • Experience with general clinical pharmacology (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.
  • Technical ability in pharmacometrics methodology and application.

BENEFITS

  • Medical, Dental Vision
  • 401K
  • Paid time Off

#LI-Hybrid

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

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