Associate Principal Scientist, Clinical Operations

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 or 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 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; 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 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 years of pharmaceutical, clinical drug development, project management, and/or medical field experience.

OR PhD/PharmD Degree +2 years of pharmaceutical, clinical drug development, project management, and/or medical field experience.

Degree in life sciences preferred.

Ideal Candidate Experience in conducting global clinical trials, including trial initiation through database lock.

Highly preferred

experience conducting clinical trials for Gastroenterology, Dermatology, or Rheumatology, especially autoimmune or immune‑mediated disorders.

Experience developing protocols and study‑related documents for Immunology‑related clinical trials.

Experience reviewing 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.

Salary and Benefits Salary range

$142,400.00 – $224,100.00.

A role in good faith belief of pay based on education, experience, location and other factors.

Eligible for annual bonus and long‑term incentive, if applicable.

We offer a comprehensive benefits package including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days.

Employment Equity Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.

As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

Hybrid Work Model Effective September 5, 2023, employees in U.S. office‑based positions will work a hybrid schedule of three total days on‑site per week (Monday–Thursday, specific days may vary) and Friday remote. #J-18808-Ljbffr