Associate Principal Scientist, Clinical Operations

MSD • Rahway, NJ

23d • 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

• PhD/PharmD/OD +2 years Ophthalmology/Retina Related experience in industry or academia required.
• 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.
• 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
• 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
• Adaptability
• Analytical Problem Solving
• Biological Sciences
• Clinical Data Interpretation
• Clinical Data Management
• Clinical Operations
• Clinical Research
• Clinical Site Management
• Clinical Study Design
• Clinical Study Management
• Clinical Trial Compliance
• Clinical Trials
• Clinical Trials Operations
• Conflict Resolution
• Data Analysis
• Drug Development
• Ethical Standards
• Good Clinical Practice (GCP)
• Health Literacy
• Life Science
• Medical Writing
• People Management
• Prioritization
• Stakeholder Alignment

Nice To Haves

• Degree in life sciences, preferred.

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.

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
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree