Associate Principal Scientist, Clinical Operations - Immunology

MSD•San Diego, PA

1d•Hybrid

About The Position

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.

Requirements

Bachelor's Degree +9 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR Master's Degree +6 year of pharmaceutical, clinical drug development, project management, and/or medical field experience OR PhD/PharmD Degree +2 year of pharmaceutical, clinical drug development, project management, and/or medical field experience
Degree in life sciences, preferred.
Demonstrated ability to drive and manage scientific activities on clinical protocols.
Accountability
Adaptability
Analytical Problem Solving
Clinical Data Interpretation
Clinical Data Management
Clinical Immunology
Clinical Operations
Clinical Research
Clinical Study Design
Clinical Study Management
Clinical Trials
Clinical Trials Operations
Conflict Resolution
Data Analysis
Dermatology
Drug Development
Ethical Standards
Good Clinical Practice (GCP)
Health Literacy
Innovation
Machine Learning (ML)
Medical Writing
People Management
Prioritization

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 or Rheumatology, especially autoimmune or immune-mediated disorders.
Experience in developing protocols and study related documents for Immunology related 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 Immunology related clinical trials.
Experience in performing medical monitoring in Immunology related clinical trials.

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.
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