Job Description
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. 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). Leads the 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. Represent the company through external partnerships, collaborations, and key strategic engagements. 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. 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. Effectively delegate and assign activities to meet 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
Bachelor's Degree +9 years of pharmaceutical, clinical drug development, project management, and/or medical field experience in ophthalmology. Master's Degree +6 years of pharmaceutical, clinical drug development, project management, and/or medical field experience in ophthalmology. PhD/PharmD Degree +2 years of pharmaceutical, clinical drug development, project management, and/or medical field experience in ophthalmology. Degree in life sciences, preferred. Required Skills
Adaptability Business Management Clinical Data Clinical Operations Clinical Protocol Clinical Research Clinical Study Design Clinical Trial Compliance Clinical Trial Management Clinical Trials Clinical Trials Analysis Conflict Resolution Data Analysis Drug Development Ethical Standards ICH GCP Guidelines Medical Writing Motivation Management Ophthalmology Prioritization Project Management Regulatory Compliance Regulatory Documents Scientific Publications Strategic Thinking Benefits
Relocation: No relocation. VISA Sponsorship: No. Travel Requirements: 10%. Work Arrangement: Hybrid. Shift: Not Indicated.
#J-18808-Ljbffr
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. 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). Leads the 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. Represent the company through external partnerships, collaborations, and key strategic engagements. 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. 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. Effectively delegate and assign activities to meet 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
Bachelor's Degree +9 years of pharmaceutical, clinical drug development, project management, and/or medical field experience in ophthalmology. Master's Degree +6 years of pharmaceutical, clinical drug development, project management, and/or medical field experience in ophthalmology. PhD/PharmD Degree +2 years of pharmaceutical, clinical drug development, project management, and/or medical field experience in ophthalmology. Degree in life sciences, preferred. Required Skills
Adaptability Business Management Clinical Data Clinical Operations Clinical Protocol Clinical Research Clinical Study Design Clinical Trial Compliance Clinical Trial Management Clinical Trials Clinical Trials Analysis Conflict Resolution Data Analysis Drug Development Ethical Standards ICH GCP Guidelines Medical Writing Motivation Management Ophthalmology Prioritization Project Management Regulatory Compliance Regulatory Documents Scientific Publications Strategic Thinking Benefits
Relocation: No relocation. VISA Sponsorship: No. Travel Requirements: 10%. Work Arrangement: Hybrid. Shift: Not Indicated.
#J-18808-Ljbffr
