Pearl Therapeutics, a wholly-owned subsidiary of AstraZeneca, is a growing, dynamic company focused on developing inhalation combination therapies for the treatment of highly prevalent chronic respiratory diseases, including chronic obstructive pulmonary disease (COPD) and asthma. Pearl is seeking to hire individuals that bring energy and passion to deliver the medicines that provide patients and healthcare provider’s therapies to achieve better clinical outcomes.
Purpose: Lead or support the planning, execution and reporting of clinical trials and registries, within budget and in compliance with company processes and regulatory requirements.
Duties and Responsibilities:
• Under supervision, responsible for the preparation and implementation of clinical trials and registries (safety, data consistency, trial timelines, budget, resources, eligibility and enrollment).
• Under general direction interacts with external Contract Research Organizations (CROs) regarding day-to-day activities of clinical trials.
• Contributes to the preparation of clinical program documents (study proposals, study protocols, clinical study reports (CSR) and submissions) if applicable.
• Leads or participates on the clinical trial team.
• Leads or participates in the Medical Review Committee.
• Liaise with Drug Supply Management and Regulatory Affairs for medication supplies for trials.
• May function as a liaison to site investigators and opinion leaders.
• Collaborate with the scientific communication director in support of publications.
• Other duties and responsibilities as assigned.
• Bachelor’s Degree in Life Sciences, Nursing or equivalent.
• Minimum 1-3 years’ experience in drug development for this role. Clinical trial experience a must from the industry.
• Basic working knowledge of clinical database systems.
• Knowledge of clinical trial design; basic statistics and pharmacokinetics a plus.
• Solid medical/scientific writing skills; ability to effectively communicate across the business organization.
• Knowledge of Respiratory therapeutic areas strongly preferred.
• Knowledge of good clinical practices (GCP/ICH) and regulatory requirements.
• Ability to collaborate and work effectively in teams.
• Strong verbal and written communication skills.
• Proficiency with Microsoft Office products.
• Demonstrates competencies in line with established profile.