Senior Scientist, Clinical Operations - Immunology

MSD•San Diego, PA

3d•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.

Requirements

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.
Accountability
Adaptability
Clinical Data
Clinical Operations
Clinical Research
Clinical Study Design
Clinical Trial Compliance
Clinical Trial Management
Clinical Trials
Data Analysis
Dermatology
Drug Development
Ethical Standards
ICH GCP Guidelines
Life Science
Medical Writing
Motivation Management
Ophthalmology
Parasitology
Prioritization
Regulatory Compliance
Regulatory Documents
Rheumatology
Scientific Publications

Nice To Haves

Experience in conducting global clinical trials, including trial initiation through database lock.
Highly Preferred: experience in conducting clinical trials for Gastroenterology, Dermatology, Rheumatology, or ophthalmology, especially autoimmune or immune-mediated disorders.
Experience with review of participant eligibility for trials (e.g., inclusion and exclusion criteria)
Experience with imaging vendors, clinical outcome assessments, biomarker sample collection and management, and external data monitoring committee.

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.
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: