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Bayer
Cambridge, MA, United States
30+ days ago
Bayer
Cambridge, MA, United States
30+ days ago
Bayer
Cambridge, MA, United States
30+ days ago
Bayer
Cambridge, MA, United States
30+ days ago
Bayer
Whippany, NJ, United States
30+ days ago
Bayer
Cambridge, Massachusetts, United States
30+ days ago

Description

(CAR-T) Sr. Director Oncology Cell Therapies Clinical Pharmacology Lead 

Bayer is Hiring for several newly created Cell Therapy openings!

This position will establish a Clinical Pharmacology expertise focused on oncology cell therapeutics. Driving strategic and operational decision making related to clinical PKPD and clinical pharmacology n multiple project team. Conducting PK/PD analyses to guide decision making n the project teams and collaborate with research and clinical teams to develop strategies for optimizing clinical benefit of cell therapies.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Oncology Cell Therapies Clinical Pharmacology Lead, are to: 

  • Provide Pharmacokinetic/Pharmacodynamics (PKPD) leadership, support and guidance to clinical project teams;
  • Design and oversee the conduct of clinical pharmacology studies (either standalone or within broader clinical trials), including dosing strategy for pivotal clinical trials, to generate high quality and relevant data;
  • Work in close partnership with clinical development and statisticians in preparing appropriate documents or sections of clinical protocols, Investigator Brochures etc.;
  • Lead the analysis, interpretation, integration and reporting of clinical pharmacokinetic and pharmacodynamic data;
  • Develop an understanding of the relationship between clinical data and preclinical findings to inform individual development programs as well as broader technology platform research;
  • Provide PKPD input for regulatory submissions such as briefing documents, IND, Clinical Trial Application (CTA) and New Drug Application (NDA);
  • Represent cell therapy clinical pharmacology in interactions with and responses to regulatory agencies;
  • Network with external expert consultants, Clinical Research Organization (CRO) partners and academic sites to problem solve and develop scientific solutions to clinical pharmacology issues;
  • Write clinical study reports related to clinical pharmacology studies or data, participate in the preparation of abstracts and manuscripts for publication;
  • Partner closely partner with Research, Bioanalytical, Clinical functions, Regulatory, Project Management, and other Research and Development (R&D) functions, providing input to pre-clinical programs;
  • Participate in due diligence to evaluate external opportunities.


Requirements

WHO YOU ARE

Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

  • Ph.D. or PharmD or MD in Pharmacokinetics, Pharmacology, Pharmaceutics;
  • At least five years of clinical pharmacology experience in the biotech/pharmaceutical industry;
  • At least two years of clinical pharmacology experience in Oncology cell therapies;
  • Be a pharmacology leader who brings scientific and clinical know how from experience in developing cell therapies in Oncology;
  • Knowledge and experience with regulatory guidance related to clinical pharmacology;
  • Strong working knowledge of pharmacokinetics and modeling, PKPD principles, ADME concepts, and clinical pharmacology;
  • Proficient in using pharmacokinetic and modeling software;
  • Strong communication skills (verbal and written) and presentation skills;
  • Excellent interpersonal skills and the ability to function in a highly matrixed team environment.

Job Information

  • Job ID: 57917197
  • Location:
    Cambridge, Massachusetts, United States
    Whippany, New Jersey, United States
  • Position Title: Oncology Cell Therapy Clinical Pharmacology Lead
  • Company Name: Bayer
  • Job Function: Industry: Research
  • Work Setting: Industry/Biotech
  • Job Type: Full-Time
  • Job Duration: Indefinite

Please refer to the company's website or job descriptions to learn more about them.

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