Associate Principal Scientist, Clinical Operations - Immunology

Job Description

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.

Job 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.

Core Skills

Demonstrated ability to drive and manage scientific activities on clinical

protocols. This position may represent the company through external partnerships, collaborations, and key strategic engagements. This includes the ability to:

• 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

Education/Experience

• 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.

Ideal candidate would have:

• 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.

clinicaltrialjobs  

EligibleforERP

Required Skills:

Accountability, 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 {+ 4 more}

Preferred Skills:

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