Senior Clinical Scientist

Merck & Co.•North Wales, PA

64d•Hybrid

About The Position

Ophthalmology Clinical Scientist: Job Summary This position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the opportunity to demonstrate your leadership, technical skills, and scientific acumen as part of a global, cross functional team.

Requirements

Demonstrated ability to drive and manage scientific activities on clinical protocols.
Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
Ability to manage multiple competing priorities with good planning, time management and prioritization skills.
Strong 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 in driving toward study goals.
Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division.
Applying leadership skills to processes, leading meetings, and influencing peers in a matrix environment
Problem solving, prioritization, conflict resolution, and critical thinking skills
Build team capabilities through proactive coaching
Strong communication, technical writing, and presentation skills
Bachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR Master's Degree +3 year of pharmaceutical, clinical drug development, project management, and/or medical field experience OR PhD/PharmD Degree
Degree in life sciences, preferred.
Adaptability
Clinical Data
Clinical Operations
Clinical Study Design
Clinical Trial Compliance
Clinical Trial Management
Communication
Data Analysis
Ethical Standards
ICH GCP Guidelines
Medical Writing
Motivation Management
Regulatory Compliance
Regulatory Documents
Science
Scientific Publications
Social Collaboration

Nice To Haves

Experience in conducting global clinical trials, including trial initiation through database lock.
Highly Preferred: experience in conducting clinical trials in ophthalmology, such as uveitis, AMD (age-related macular degeneration), thyroid eye disease.
Experience in developing protocols and study related documents for ophthalmology clinical trials.
Experience with imaging vendors, clinical outcome assessments, biomarker sample collection and management, and external data monitoring committee for ophthalmology clinical trials.
Experience with review of participant eligibility for trials (e.g., inclusion and exclusion criteria and prohibited/concomitant medications) with a high focus in ophthalmology clinical trials.
Experience in performing medical monitoring in ophthalmology clinical trials
Experience with ophthalmologic assessments, e.g (slit lamp. dilated indirect ophthalmoscopy DIO}, imaging assessments such as optical coherence tomography OCT}; fluorescein angiography FA}, fundus photography FP} and visual acuity assessments such as best corrected visual acuity BCVA} performed in ophthalmology clinical trials.

Responsibilities

Responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s). This may include: Serving as the lead clinical scientist on the clinical trial team. Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with the Clinical Director.
Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments); Partners with the Study Manager on study deliverables.
Ensuring CRF design supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of trial conduct.
Providing tactical/scientific mentorship to other clinical scientists.
This position may represent the company through external partnerships, collaborations, and key strategic engagements.