Director, Trial Physician, Medical Director, Orphan Lung Programs

• Study Execution in a GCP compliant way
  • Be accountable for study recruitment
  • Ensuring highest quality of data generation and collection
  • Ensuring study activities are GCP compliant
  • Medical monitoring
  • CRO Management
  • Collaborate with Biostatistics / Data Management for statistical support and data capturing.
  • Oversee safety oversight activities across different programs and trials
  • Safety and Pharmacovigilance for adverse events assessments and reporting.
  • Contribute to the logistical conduct of studies in very close collaboration with Clinical Operations to select and establish effective communication with external vendors.
  • Collaborate with Regulatory Affairs to align studies with local, national and international health authority requirements.
  • Quality Assurance to guarantee health information privacy and data integrity.

• Study Planning:
  • Assist with the strategic planning and execution (including study design, method selection, etc…) of Phase 1 through 4 clinical trials.
  • Review literature and consult with internal experts and external advisors and advisory boards, contributing to identifying these experts and assembling these boards.
  • Delineate participants' eligibility criteria for study participation and selecting clinical endpoints.
  • Demonstrate understanding and the ability to utilize corollary tools such as mathematical models to evaluate the study data. Act as clinical study lead for assigned study(ies).

• Additional Study-Related Activities:
  • Contributes to the preparation of regulatory documents for IND filing (e.g., IND modules and ICF), NDA, and collaborating with preclinical research functions (e.g., Pharmacology and Toxicology).
  • Prepares and presents material for first-in-human committees; prepares study reports, collaborating with Medical Writing.
  • Responsible for or contributes to (in conjunction with a CRO medical monitor) study medical monitoring.
  • Analyze and interpret data and clearly communicate results both internally and externally.
  • Contribute to and review clinical documents (slide presentations, protocols, clinical study reports, regulatory submission sections, investigator’s brochures, etc.)
  • Work collaboratively with other Medical Directors, and colleagues in Biostatistics, Medical Writing, Drug Safety, Clinical Operations, Translational Medicine, and Regulatory Affairs.
  • Work closely with Contract Research Organizations, Principal Investigators, Advisory Boards, key opinion leaders, and US and global regulators.

• Additional Activities:
  • Represents Clinical Development on study and project teams and may also act as project team leader;
  • presents to senior management;
  • supports business development activities (e.g., conducting due diligence).
  • Supporting the clinical, medical and safety activities in the endocrinology therapeutic area, if needed.
  • Other activities not fully captured in the above, based on the organization’s needs

• MD with 6+ years of experience in pharmaceutical drug development.
• Strong preference for pulmonologists
• Demonstrated expertise in Pulmonary Disorders or trials is a major plus

• Excellent verbal, interpersonal and written communication skills, a strong scientific background with industry drug development experience, creativity, and flexibility.
• Strong team leadership skills are required.
• Ability to work in a team environment with both internal and external (e.g., CRO) members.
• Experience working with study investigators and staff at clinical sites
• Experience in clinical trial design specific to pulmonary disorders.
• Familiarity with thought leaders in the fields of NTM, IPF, CF and/or related pulmonary disorders is a major plus.
• Domestic and international travel (approximately 20%) is required.

Contact Information