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
ā¢ Responsible for the clinical/scientific execution of clinical protocol(s).
ā¢ Serves as the lead clinical scientist on the clinical trial team.
ā¢ Collaborates with the Medical Writer on clinical/scientific and regulatory documents.
ā¢ Partners with Study Manager on study deliverables.
ā¢ Participates in the set up and design during study start up (e.g., database set up)
ā¢ Lead medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaboration with the Clinical Director.
ā¢ Builds talent and capabilities of direct/indirect team members through proactive coaching, mentoring and development opportunities.
ā¢ May include management of direct reports including assignment of resources, professional development, and performance management.
ā¢ May serve as a subject matter expert and/or participate on process improvement teams.
ā¢ Apply strong knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
ā¢ Manage multiple competing priorities with good planning, time management and prioritization skills
ā¢ Advanced analytical skills with the ability to interpret clinical trial data and synthesize conclusions
ā¢ Interact with key stakeholders across department, division, and company.
ā¢ Role requires a proactive approach, strategic thinking and leadership driving toward study goals.
ā¢ Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division
ā¢ Demonstrated ability to effectively delegate and assign activities to meet the business needs
ā¢ Problem solving, prioritization, conflict resolution, and critical thinking skills
ā¢ Build team capabilities through proactive coaching
ā¢ Advanced communication, technical writing, and presentation skills
Requirements
ā¢ 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
ā¢ Degree in life sciences, preferred.
ā¢ Demonstrated ability to drive and manage scientific activities on clinical protocols.
ā¢ Accountability
ā¢ Adaptability
ā¢ Analytical Problem Solving
ā¢ Clinical Data Interpretation
ā¢ Clinical Data Management
ā¢ Clinical Immunology
ā¢ Clinical Operations
ā¢ Clinical Research
ā¢ Clinical Study Design
ā¢ Clinical Study Management
ā¢ Clinical Trials
ā¢ Clinical Trials Operations
ā¢ Conflict Resolution
ā¢ Data Analysis
ā¢ Dermatology
ā¢ Drug Development
ā¢ Ethical Standards
ā¢ Good Clinical Practice (GCP)
ā¢ Health Literacy
ā¢ Innovation
ā¢ Machine Learning (ML)
ā¢ Medical Writing
ā¢ People Management
ā¢ Prioritization
Nice-to-haves
ā¢ Experience in conducting global clinical trials, including trial initiation through database lock.
ā¢ Highly Preferred: experience in conducting clinical trials for Gastroenterology, Dermatology or Rheumatology, especially autoimmune or immune-mediated disorders.
ā¢ Experience in developing protocols and study related documents for Immunology related clinical trials
ā¢ 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.
ā¢ Experience in performing medical monitoring in Immunology related clinical trials.
Benefits
ā¢ medical
ā¢ dental
ā¢ vision healthcare and other insurance benefits (for employee and family)
ā¢ retirement benefits, including 401(k)
ā¢ paid holidays
ā¢ vacation
ā¢ compassionate and sick days
Apply Now
Apply Now
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
ā¢ Responsible for the clinical/scientific execution of clinical protocol(s).
ā¢ Serves as the lead clinical scientist on the clinical trial team.
ā¢ Collaborates with the Medical Writer on clinical/scientific and regulatory documents.
ā¢ Partners with Study Manager on study deliverables.
ā¢ Participates in the set up and design during study start up (e.g., database set up)
ā¢ Lead medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaboration with the Clinical Director.
ā¢ Builds talent and capabilities of direct/indirect team members through proactive coaching, mentoring and development opportunities.
ā¢ May include management of direct reports including assignment of resources, professional development, and performance management.
ā¢ May serve as a subject matter expert and/or participate on process improvement teams.
ā¢ Apply strong knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
ā¢ Manage multiple competing priorities with good planning, time management and prioritization skills
ā¢ Advanced analytical skills with the ability to interpret clinical trial data and synthesize conclusions
ā¢ Interact with key stakeholders across department, division, and company.
ā¢ Role requires a proactive approach, strategic thinking and leadership driving toward study goals.
ā¢ Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division
ā¢ Demonstrated ability to effectively delegate and assign activities to meet the business needs
ā¢ Problem solving, prioritization, conflict resolution, and critical thinking skills
ā¢ Build team capabilities through proactive coaching
ā¢ Advanced communication, technical writing, and presentation skills
Requirements
ā¢ 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
ā¢ Degree in life sciences, preferred.
ā¢ Demonstrated ability to drive and manage scientific activities on clinical protocols.
ā¢ Accountability
ā¢ Adaptability
ā¢ Analytical Problem Solving
ā¢ Clinical Data Interpretation
ā¢ Clinical Data Management
ā¢ Clinical Immunology
ā¢ Clinical Operations
ā¢ Clinical Research
ā¢ Clinical Study Design
ā¢ Clinical Study Management
ā¢ Clinical Trials
ā¢ Clinical Trials Operations
ā¢ Conflict Resolution
ā¢ Data Analysis
ā¢ Dermatology
ā¢ Drug Development
ā¢ Ethical Standards
ā¢ Good Clinical Practice (GCP)
ā¢ Health Literacy
ā¢ Innovation
ā¢ Machine Learning (ML)
ā¢ Medical Writing
ā¢ People Management
ā¢ Prioritization
Nice-to-haves
ā¢ Experience in conducting global clinical trials, including trial initiation through database lock.
ā¢ Highly Preferred: experience in conducting clinical trials for Gastroenterology, Dermatology or Rheumatology, especially autoimmune or immune-mediated disorders.
ā¢ Experience in developing protocols and study related documents for Immunology related clinical trials
ā¢ 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.
ā¢ Experience in performing medical monitoring in Immunology related clinical trials.
Benefits
ā¢ medical
ā¢ dental
ā¢ vision healthcare and other insurance benefits (for employee and family)
ā¢ retirement benefits, including 401(k)
ā¢ paid holidays
ā¢ vacation
ā¢ compassionate and sick days
Apply Now
Apply Now