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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical research management, including the design and execution of clinical trials, particularly in rheumatologic diseases. Possesses strong analytical skills for evaluating clinical findings and regulatory compliance, along with the ability to collaborate effectively across interdisciplinary teams.
Highest-signal resume keywords
Clinical Research ManagementPhase 2 or 3 Clinical TrialsRegulatory ComplianceData AnalysisStrategic Planning
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial DevelopmentClinical JudgmentEthical StandardsScientific PublicationsVaccinology
Soft Skills
Interpersonal SkillsCollaborative TeamworkMentorshipIntellectual CuriosityInterdisciplinary Problem Solving
Certifications & Qualifications
M.D.D.O.M.D./PhDD.O./PhD
Industry Keywords
ImmunologyClinical Development CycleInvestigational New Drug ApplicationsRheumatologic DiseasesScientific Consulting
About the role
Key responsibilities & impact- Strategically plan and direct clinical research activities involving investigational compounds in Immunology
- Manage the full clinical development cycle, including disease indication selection, study design, initiation, execution, monitoring, analysis, regulatory filing, and publication
- Evaluate pre-clinical and translational work to generate early clinical development plans and Investigational New Drug applications
- Support business development assessments of external opportunities to grow the Immunology Pipeline
- Develop clinical development strategies and plan clinical trials, including design, operational plans, and settings
- Monitor and manage ongoing and new clinical trials for investigational drugs
- Analyze and summarize clinical findings to support safety and efficacy decisions, new drug applications, clinical study reports, and publications
- Participate in internal and joint internal/external research project teams
- Supervise Clinical Scientists in executing clinical studies
- Collaborate with commercialization, regulatory affairs, statistics, and manufacturing experts on clinical development projects
- Keep corporate personnel informed about study progress, competitor drugs, and relevant scientific questions
- Maintain scientific knowledge of developments and research methodologies in the area of expertise
- Identify strong investigators for development of investigational Immunology drugs
- Establish collaborations with external experts in rheumatology diseases
- Attend scientific meetings
- Author development documents, presentations, budgets, and position papers
- Facilitate collaborations with external researchers around the world
- Travel approximately 20% to manage future or ongoing clinical research projects
Requirements
What you’ll need- M.D., D.O., M.D./PhD, or D.O./PhD
- Minimum of 5 years of clinical and/or development experience in academia, clinical medicine, and/or corporate clinical development
- Minimum of 3 years of industry experience in drug development or biomedical research experience in academia
- Demonstrated record of scientific scholarship and achievement
- Strong interpersonal skills and ability to work collaboratively in a cross-functional team environment
- Prior experience in design and execution of Phase 2 or 3 clinical trials in rheumatologic diseases is preferred
- Knowledge and skills in Clinical Judgment, Clinical Medicine, Clinical Research Management, Clinical Trial Development, Data Analysis, Decision Making, Ethical Standards, Intellectual Curiosity, Interdisciplinary Problem Solving, Mentorship, Regulatory Compliance, Scientific Consulting, Scientific Publications, Strategic Planning, and Vaccinology
- US and Puerto Rico residents only
- Ability to travel on company business approximately 20% of the time
Benefits
Comp & perks- Annual bonus eligibility
- Long-term incentive eligibility, if applicable
- Medical, dental, vision healthcare and other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Hybrid work arrangement