A leading healthcare staffing firm in the United States is seeking an experienced professional to oversee clinical development activities. The ideal candidate will have a PhD or PharmD and over 12 years of experience in clinical development, particularly in the cardio-pulmonary therapeutic area. Responsibilities include guiding clinical trial design, participating in pharmacovigilance activities, and representing the company at external events. This role requires strong collaborative and analytical skills, along with a commitment to scientific integrity.
Qualifications
12+ years of industry experience in clinical development.
Knowledge of the cardio-pulmonary therapeutic area.
Experience using data visualization tools in a clinical environment.
Responsibilities
Oversee all aspects of clinical development activities.
Participate in pharmacovigilance activities.
Represent the company at key external engagements.
Skills
Data visualization
Adaptive problem solving
Outstanding teamwork
Strong computer skills
Education
PhD or PharmD
Tools
Data analysis software
Job description
Oversee all aspects of clinical development activities of assigned program, including clinical study design, protocol development and amendments, investigator brochures, annual reports, and clinical study reports
Provide guidance on scientific and clinical issues that arise during trial execution, ensuring timely resolution and continuous improvement
Ensure trials are scientifically robust, operationally feasible, and compliant with ethical standards and regulatory guidelines
Develop and leverage data analytics to support clinical trial oversight, including enrollment, protocol adherence, safety trends, and endpoint monitoring and identify emerging clinical or operational risks
Cross-Functional Collaboration
Participate in pharmacovigilance activities, including safety reviews and adverse event reporting
Serve as a liaison across internal functions such as Clinical Operations, Medical Affairs, Regulatory and Biometrics
Support investigator meetings and work closely with Field Medical and Clinical Operations to optimize patient recruitment, site engagement, and trial execution
Scientific Communication & External Engagement
Represent the company at key external engagements including scientific congresses, investigator meetings and public forums
Support the development of publications that align with scientific/medical communication goals
Requirements
PhD or PharmD required, with 12+ years of industry experience in clinical development
Knowledge of the cardio-pulmonary therapeutic area
Experience using data visualization and related analytics tools in a clinical development or life sciences environment to monitor study performance and identify emerging clinical or operational risks
Adaptive problem solving and learning and ability to navigate organizations and systems
Ability to frame clear & succinct messages and simplify complexity of decision making
Knowledge of the principles of clinical trial methodology, statistics, data analysis and interpretation
Outstanding teamwork and collaboration skills; comfortable working in a flexible, dynamically changing, and challenging environment
Strong computer and data management skills and proficient in data analysis software and data presentation
Highest level of scientific integrity
Willingness to travel ~20%, with international travel at times