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Director, Global Clinical Pharmacology, Biologics

3 months ago

Northbrook, United States Astellas Pharmaceuticals Full time

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

The Director, Global Clinical Pharmacology will have ultimate responsibility and accountability for clinical pharmacology from first-in human through approval, including post-marketing activities for assigned projects.

The Director will be responsible for therapeutic optimization and individualization (right dose for right patient) by applying state-of-the-art scientific principles and quantitative framework (e.g. MIDD) to evaluate exposure-response relationships based on knowledge of drug disposition, pharmacology, disease biology, patient population, competitive landscape, background therapy, patient variability in PK and responses, formulation effects, impact of immunogenicity.

Essential Job Responsibilities:

  • Representing the department and providing subject matter expertise on cross-functional project teams starting with candidate nomination (pre-initiation of GLP tox) through approval and post marketing
  • Leading cross-functional sub-teams necessary by phase of development to achieve Clinical Pharmacology goals
  • Providing effective oversight of clinical pharmacology aspects of clinical trials (including study design, interpretation and communication of results)
  • Participating in cross-functional discussions and collaborating with individuals across disciplines; mentoring junior members
  • Authoring/reviewing clinical protocols, analysis plans, study reports and regulatory submissions
  • Developing high quality clinical pharmacology plans and content for global regulatory submissions, including INDs, IBs, NDAs, MAAs, diversity and pediatric plans
  • Presentation of clinical pharmacology aspects of the global clinical development program at internal and external meetings. For example: meetings with health authorities, congresses, investigator meetings
Quantitative Dimensions:
  • Be involved in the design, analysis, and reporting at least 3 to 10 clinical studies per year
  • As a global clinical pharmacology lead (GCPL), provide the scientific lead for a cross-functional team of 15 - 25 people
  • Supervise 1-3 junior GCPLs.
  • Responsibilities may directly impact on strategy and efficiency of clinical development of compounds.
  • Has responsibilities for contributing to the overall annual budgeting and assessment of resources for assigned projects for executing clinical pharmacology strategy from FIM to registration
  • Has responsibilities that directly impacts on strategy and efficiency of clinical development of compounds, especially in the early and late phases.
Organizational Context:
  • Reports to Clinical Pharmacology Senior Director or higher, within Early Development
  • May have direct reporting global or regional clinical pharmacologists
  • May have functional management of scientists
Qualifications:

Required
  • PhD or PharmD with fellowship in clinical pharmacology
  • At least 7 years post-graduate experience, in pharmaceutical industry.
  • Thorough knowledge of current and emerging scientific standards and global regulatory requirements including familiarity with relevant guidance
  • Working knowledge of assigned therapeutic area, biomarkers, bioanalytical methods, immunogenicity
  • Have thorough understanding of early development, clinical methodologies, POC, and clinical endpoints within a specific therapeutic area
  • Knowledge of biologics drug development
  • Excellent written and oral communication skills and ability to convey complex technical information clearly
  • Expert knowledge of clinical pharmacology in drug development, with a strong scientific and strategic mindset and experience with clinical dose setting (including first in human dose setting) and pharmacokinetic/pharmacodynamic relationships
  • Experience integrating modeling and simulation activities (i.e., population PK, exposure-response and physiologically based PK) to support the clinical pharmacology plan
  • Adaptability and curiosity to learn about new modalities and apply core clinical pharmacology principles to novel therapeutics
  • Curiosity and drive to ask questions, learn and keep abreast of literature
  • Confidence and ability to present to and influence senior leaders
  • Ability to critically analyze problems and provide creative/innovative solutions
  • Ability and confidence to work independently
Benefits:
  • Medical, Dental and Vision Insurance
  • Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
  • 401(k) match and annual company contribution
  • Company paid life insurance
  • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
  • Long Term Incentive Plan for eligible positions
  • Referral bonus program

Category BP Clinical Science

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EOE including Disability/Protected Veterans