Assoc Prin. Scientist, Clin. Operations (m/f/d) Full-time

Clinical Trial Scientist

This position drives scientific planning, strategy, and execution of Phase 1-4 clinical studies. Under the direction of the Program Lead, you will collaborate with global cross-functional team members including clinical directors and study managers to lead/support clinical trial scientific activities.

Job Responsibilities

• Responsible for the clinical/scientific execution of clinical protocol(s).
• Serves as the lead clinical scientist on the clinical trial team.
• Collaborates with the Medical Writer on clinical/scientific and regulatory documents.
• Partners with Study Manager on study deliverables.
• Participates in the set up and design during study start up (e.g., database set up)
• Lead medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaboration with the Clinical Director.
• Builds talent and capabilities of direct/indirect team members through proactive coaching, mentoring and development opportunities.
• May include management of direct reports including assignment of resources, professional development, and performance management.
• May serve as a subject matter expert and/or participate on process improvement teams.

Core Skills

Demonstrated ability to drive and manage scientific activities on clinical protocols. This position may represent the company through external partnerships, collaborations, and key strategic engagements.

This includes the ability to:

• Apply strong knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
• Manage multiple competing priorities with good planning, time management, and prioritization skills
• Advanced analytical skills with the ability to interpret clinical trial data and synthesize conclusions
• Interact with key stakeholders across department, division, and company. Role requires a proactive approach, strategic thinking and leadership driving toward study goals.
• Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division
• Demonstrated ability to effectively delegate and assign activities to meet the business needs
• Problem solving, prioritization, conflict resolution, and critical thinking skills
• Build team capabilities through proactive coaching
• Advanced communication, technical writing, and presentation skills

Education/Experience Preferred

• Bachelor's Degree +9 years of pharmaceutical, clinical drug development, project management, and/or medical field experience in ophthalmology
• OR Master's Degree +6 year of pharmaceutical, clinical drug development, project management, and/or medical field experience in ophthalmology
• OR PhD/PharmD Degree +2 year of pharmaceutical, clinical drug development, project management, and/or medical field experience
• Degree in life sciences, preferred.

Required Skills: Adaptability, Analytical Problem Solving, Clinical Data Management, Clinical Operations, Clinical Study Design, Clinical Study Management, Clinical Trials Operations, Data Analysis, Ethical Standards, Good Clinical Practice (GCP), Health Literacy, Medical Writing, People Management, Stakeholder Alignment, Strategic Thinking

Preferred Skills: