PRAHS

2017-42434

- | US-Remote
2 days ago
Title
Director of Scientific Affairs-Clinical Pharmacology

Overview

The Scientific Affairs-Clinical Pharmacology team within Scientific Affairs of the PRA Business Unit Scientific & Medical Affairs, Safety & Commercialization Services 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.  In order to do so, 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’. The job role is to define and detail the drug development strategy, based on a well-crafted Target Product Profile as ultimate development goal. With a good understanding of the concepts of drug development over various therapeutic areas, he/she applies 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 collaboration with PRA Therapeutic Expert, designs or reviews the product’s target product profile.
  • In collaborations with PRA Therapeutic Expert, 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.
  • Collaborates with clients on the design of drug development programs.
  • Provides formal, in-house classroom training to members of EDS when necessary.
  • Routinely provides departmental updates on recent developments in the field of early clinical development, clinical pharmacology, PK, PD and biomarker concepts and applications.
  • Directs a group responsible for clinical pharmacology, PK, and PD activities, if applicable.
  • 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.
  • Provides support to proposals for full development programs and for individual clinical studies.
  • Provides support in the production of promotional material; (co-)authors scientific white papers of fact sheets.
  • Participates in RFP bid defenses; provides client consulting at the RFP stage.
  • Participates on project level activities when required.
  • May assume role of project leader or lead scientist/clinical pharmacologist/ pharmacokineticist for specific projects, when appropriate.
  • Reviews the communication from other team members, if applicable.
  • 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:

  • Pharm.D. with Ph.D. or M.D. with Ph.D. with >15 years of early clinical development experience in the clinical pharmacology, drug metabolism, and PK/PD domains in different therapeutic areas; experience in managing a group of scientists.
  • > 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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