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2017-38951

2017-38951

Title 
Director of Scientific Affairs- Early Development Services
Job Locations 
-
US-Remote
Posted Date 
12/15/2017

More information about this job

Overview

The Scientific Affairs-Clinical Pharmacology team is responsible for providing clients and the internal organization with scientific support in the design, conduct and reporting of early clinical development and clinical pharmacology programs, and the underlying individual clinical studies.  The department maintains intensive relationships with clients, the scientific community, regulators, key opinion leaders, and subcontractors such as specialty labs. The department advises internally and externally about program and study design, and research models. It monitors scientific and medical developments, and takes the lead to incorporate these in programs and supports their practical implementation. The department is a key function in PRA’s objective of ‘Leading with Science’ through application of a wide range of clinical pharmacology, pharmacokinetic, and pharmacodynamic expertise to drug development programs, study protocols, and regulatory filing packages.

 

Responsibilities

 

  • Provides scientific expertise and management oversight to drug development through all program stages
  • In collaborations with client, PRA Therapeutic Expert and PRA Global Drug Development representative, designs or reviews the overall product development plan, with focus on the early development path to clinical proof-of-concept, and with understanding of the medical, commercial and regulatory needs and expectations.
  • Liaises with key opinion leaders and regulatory authorities for the challenge and improvement of draft target product profiles and (elements of) development plans, when appropriate.
  • May act as client representative with regulatory agencies.
  • Reviews medical and scientific literature, and reviews preclinical and clinical safety and efficacy data of novel compounds including Investigator’s Brochure, if available, for the support of the design of clinical development programs and studies.
  • Designs or reviews the outlines of studies in the early clinical development plan, including ADME, PK and PK/PD studies.
  • Reviews study results and study reports.
  • Guides the development of manuscripts and early clinical development, clinical pharmacology and/or PK/PD sections of regulatory submission documents.
  • Develops, presents, and/or publishes innovative early clinical development, PK, PD and biomarkers strategies..
  • Provides formal, in-house classroom training to PRA teams when necessary.
  • Participates in Business Development activities and the RFP process.
  • Proactively builds and maintains his/her network in the biotech and pharma landscape.
  • Interacts with potential clients on own initiative if appropriate, and when requested by Business Development.
  • Participates on project level activities when required.
  • May assume role of project leader or lead scientist/clinical pharmacologist for specific projects, when appropriate.
  • Prepares or reviews, and guides on the delivery of relevant sections of Statistical Analysis Plans, PK/PD data analysis and statistical results, and PK/PD sections of Clinical Study Reports
  • Supports the writing of clinical study protocols and study reports, and leads the writing when appropriate.
  • Works with investigators and their staff and participates in investigator meetings to ensure proper data collection techniques
  • Focuses on complex programs, including those therapeutic areas with little or no clinical development precedence.

Qualifications

  • Pharm.D., M.D., and/or Ph.D. in Pharmaceutical Sciences or a health related field with emphasis in clinical pharmacology, pharmacokinetics (including ADME, biopharmaceutics, and pharmacometrics).
  • Clinical pharmacology experience 
  • Demonstrated ability to plan, supervise, implement, and monitor the clinical pharmacology, PK and PD development and reporting processes for clinical trials.
  • Expertise in PK/PD data analysis and modeling
  • Excellent communication skills with demonstrated leadership ability.

Preferred:

  • > 10 years of working experience at large pharmaceutical company and/or small biotech 


PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

 

To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

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