Senior Clinical Scientist

MSD•San Diego, CA

22h•Hybrid

About The Position

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. The role involves leading specific aspects of clinical/scientific execution of clinical protocols, serving as the lead clinical scientist on the clinical trial team, and leading the medical monitoring team in reviewing and interpreting clinical data and medical protocol deviations in collaboration with the Clinical Director. You will also collaborate cross-functionally in developing protocols and related study materials, ensure CRF design supports data collection, and monitor clinical data for quality and integrity. Additionally, the position includes providing tactical/scientific mentorship to other clinical scientists.

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
Ability to interact with key stakeholders across department, division, and company
Proactive approach, strategic thinking and leadership in driving toward study goals
Ability to 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
Ability to 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
Experience in conducting global clinical trials, including trial initiation through database lock
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
Valid Driving License

Nice To Haves

Degree in life sciences
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

Leading specific aspects of clinical/scientific execution of clinical protocol(s)
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
Representing the company through external partnerships, collaborations, and key strategic engagements