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.
Job Requirements
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
