Merck · 10 hours ago
Associate Principal Scientist, Clinical Operations - Immunology
North Wales, PA
Full-time
Hybrid
Senior Level, Lead/Staff
$142K/yr - $224K/yr
6+ years expMerck is a leading pharmaceutical company focused on innovative drug development. The Associate Principal Scientist in Clinical Operations will drive scientific planning and execution of Phase 1-4 clinical studies, collaborating with cross-functional teams to ensure effective clinical trial activities.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
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
Qualification
Required
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
Demonstrated ability to drive and manage scientific activities on clinical protocols
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
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
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
Preferred
Degree in life sciences, preferred
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
Benefits
Medical
Dental
Vision healthcare and other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
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