Associate Principal Scientist, Clinical Operations - Immunology
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.
- 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
- 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.
- 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
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