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Consultant / Senior Director, Clinical Project Leader
Ref No.: 20-04897
Location: West Chester, Pennsylvania
Job Location: West Chester, PA
Job duration: 10months +
Description:

Title: Senior Director, Clinical Project Leader - Clinical Research
Department: Global Respiratory R&D

Primary purpose and function of this position:
  • The Clinical Project Leader physician (CPL) provides clinical leadership and medical monitoring of clinical studies.
  • The CPL is responsible for supporting assigned drug development projects including the
  • Planning and implementation of global clinical research and development programs across all phases of research.
  • The CPL serves as a clinical and professional resource for a given product.
  • This open position will be within the Respiratory Area.

Major duties and responsibilities that are critical and necessary, and that must be done to achieve this position's overall objective:
  • Serves as a Clinical Leader designing clinical development plans and individual clinical studies from Phase 0 to Phase IV.
  • Fully accountable for clinical trial design and leading the clinical sub-team through study execution.
  • Provides medical support and guidance in investigator selection, study initiation and study conduct, patient/subject safety or oversees CRO medical monitor.
  • Reviews safety and efficacy data, leads the study team through analysis and interpretation of the study results, and makes recommendations as to appropriate next steps.
  • Trains and mentors clinical study staff on the clinical aspects of the product and its indications.
  • Leads a team of clinical study physicians also accountable for their respective clinical trials.
  • Responsible for the clinical/medical leadership of INDs, NDAs, BLAs and other global regulatory filings.
  • Provides clinical leadership and expertise in meetings with Health Authorities globally.
  • Leadership: Ability to implement the clinical vision and strategy. To lead intra- and inter-departmental teams, matrix-manage a cross-functional team with integrity, flexibility and excellent communication skills.
  • Judgment: evidence of good clinical and scientific judgment.
  • Ability to interpret the significance of preclinical and clinical data, and to anticipate the information that will be needed to satisfy regulatory requirements.
  • Ability to progress projects safely and efficiently.
  • Know when to seek advice from colleagues and senior management.
  • Teamwork: to build and lead clinical teams and determine what resources and talents are needed for the rapid progression of the project.
  • Interact effectively across boundaries with other functions and disciplines using influencing, communication and relationship building skills.
  • Able to secure, manage and maintain critical partnerships with key business partners.
  • Collaboration: to form collaborations with key external experts to take world class science and deliver meaningful benefits for patients.
  • Any other task assigned by a supervisor.

Qualifications:
  • MD degree
  • Board certification and/or strong experience in clinical development in Pulmonary or Allergy/Immunology therapeutic areas strongly preferred
  • 8+ years of clinical development experience in a pharmaceutical industry are required
  • Proven track record of leading studies from early stage through to regulatory submission
  • Must speak fluid English and be a proficient scientific writer