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Clinical Pharm Lead (FSP)

extra holidays - extra parental leave - fully flexible
Remote: 
Full Remote
Contract: 
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Offer summary

Qualifications:

Advanced degree in Clinical Pharmacology, Pharmacy, or related field., Strong understanding of pharmacokinetics and pharmacodynamics., Experience in clinical trial design and execution., Proven leadership skills in a clinical development environment..

Key responsabilities:

  • Serve as the Clinical Pharmacology representative on drug development teams.
  • Plan and direct clinical pharmacology components of clinical programs and studies.
  • Ensure appropriate dose-finding strategies during clinical drug development.
  • Develop and implement clinical modeling and simulation plans based on best practices.

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Parexel XLarge http://www.parexel.com
10001 Employees
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Job description

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Job Description

Clinician

KEY RESPONSIBILITIES:

1, Serves as the Clinical Pharmacology representative on drug development and clinical sub-teams and provides clinical pharmacology expertise and leadership to projects.

2, Plans and directs clinical pharmacology components of clinical programs (including clinical development plan and medicine plan) and studies (including design, synopsis preparation and reporting).

3, Works with multifunctional study team to design, deliver and report the assigned clinical pharmacology studies and has overall scientific accountability for the designated studies.

4, Responsible (with Clinicians and Statisticians) for ensuring appropriate dose-finding strategies during clinical drug development that will ensure optimal doses and dosage regimens in patients.

5, Accountable for the development and implementation of a clinical modeling and simulation plan based on agreed-upon best practices (i.e. model-informed drug development).

6, Responsible for use of quantitative methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development.

7, Responsible for appropriate summarization and interpretation of results of pharmacokinetic/pharmacodynamic (PK-PD) analyses with respect to their impact on development and clinical use of drugs.

Required profile

Experience

Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Accountability
  • Collaboration
  • Leadership

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