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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Expertise in Clinical Development and Clinical Research, with a strong focus on Immunology and Rheumatology. Proven ability to manage the full clinical development cycle, including trial design, execution, and regulatory submissions.
Highest-signal resume keywords
Clinical DevelopmentClinical ResearchClinical Trial PlanningCross-Functional TeamworkImmunology
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 DesignRegulatory FilingData AnalysisInvestigational New Drug ApplicationsClinical Study ReportsPhase 2 Clinical TrialsPhase 3 Clinical TrialsTranslational ResearchSafety and Efficacy AnalysisScientific Scholarship
Soft Skills
Interpersonal SkillsCollaborative WorkTeam Leadership
Certifications & Qualifications
M.D.D.O.M.D./Ph.D.D.O./Ph.D.
Industry Keywords
ImmunologyRheumatologyClinical Development CycleClinical TrialsBusiness DevelopmentScientific MeetingsExternal CollaborationsResearch Project Teams
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 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
- Monitor and manage ongoing and new clinical trials
- 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 executing clinical studies
- Collaborate with commercialization, regulatory affairs, statistics, and manufacturing experts
- Keep corporate personnel informed about study progress, competitor drugs, and relevant scientific questions
- Maintain scientific knowledge and identify strong investigators
- Establish collaborations with external experts in rheumatologic diseases
- Attend scientific meetings
- Author development documents, presentations, budgets, and position papers
- Facilitate collaborations with external researchers worldwide
- Travel on company business to manage clinical research projects
Requirements
What you’ll need- M.D., D.O., M.D./Ph.D, or D.O./Ph.D.
- Minimum of 5 years of clinical and/or development experience
- Demonstrated record of scientific scholarship and achievement
- Strong interpersonal skills
- Ability to work collaboratively in a cross-functional team environment
- Required skills: Clinical Development, Clinical Research, Clinical Trial Planning, Cross-Functional Teamwork, Immunology, Rheumatology
- Prior experience in design and execution of phase 2 or 3 clinical trials in rheumatologic diseases is preferred
- Must be a US or Puerto Rico resident
- Visa sponsorship is not available
Benefits
Comp & perks- Annual bonus eligibility
- Long-term incentive eligibility, if applicable
- Medical, dental, and vision healthcare and other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate days
- Sick days
- Hybrid work arrangement