MSD ir globāls biofarmācijas uzņēmums, kas izstrādā zāles un vakcīnas nozīmīgu veselības problēmu risināšanai, tostarp vēža, infekcijas slimību, sirds un asinsvadu slimību un vielmaiņas traucējumu ārstēšanai, kā arī pievēršas profilaktiskajai aprūpei. Amerikas Savienotajās Valstīs, Kanādā un Puertoriko MSD ir pazīstams kā Merck & Co., Inc. MSD apvieno zinātnisko pētniecību ar izstrādes un komerciālo kompetenci, lai veselības aprūpes risinājumi būtu pieejami cilvēkiem un dzīvniekiem.
Uzņēmuma darbība aptver cilvēku veselību, dzīvnieku veselību, kā arī pētniecību un izstrādi, radot iespējas profesionāļiem zinātnes, klīniskajā, komerciālajā, operacionālajā un uzņēmuma funkciju jomā. MSD darbojas dažādos pasaules reģionos, un tās karjeras iespējas atspoguļo koncentrēšanos uz pētniecību, sadarbību, iekļaušanu un atbildīgu globālās veselības attīstību.
Senior Principal Scientist, Immunology Clinical Research — Boston Hybrid
Lead late-stage immunology clinical development at MSD, from trial planning and outcome analysis to regulatory submissions. Guide research teams and support decisions on the safety and efficacy of investigational therapies.
Apraksts
- Plan and lead clinical research on investigational immunology compounds.
- Oversee clinical development from indication selection and study design through trial execution, analysis, regulatory filing, and publication.
- Assess preclinical and translational research to shape early development plans and Investigational New Drug applications.
- Evaluate external opportunities that could expand the immunology pipeline.
- Set clinical development strategies and plan trial designs, operations, and settings.
- Monitor and manage new and ongoing trials of investigational drugs.
- Analyze and report clinical findings to inform safety and efficacy decisions, drug applications, study reports, and publications.
- Contribute to internal and collaborative research project teams.
- Supervise clinical scientists conducting studies.
- Work with commercialization, regulatory, statistics, and manufacturing teams on development projects.
- Update company staff on study progress, competing drugs, and relevant scientific questions.
- Stay current with research developments and methods in the field.
- Identify investigators for development programs involving investigational immunology drugs.
- Build partnerships with external rheumatology experts.
- Attend scientific conferences and meetings.
- Prepare development documents, presentations, budgets, and position papers.
- Enable research collaborations with external investigators worldwide.
- Travel about 20% to oversee planned and ongoing clinical research projects.
Prasības
- M.D., D.O., M.D./Ph.D., or D.O./Ph.D.
- At least five years of clinical or development experience in academia, clinical medicine, or corporate clinical development.
- At least three years of industry experience in drug development, or biomedical research experience in academia.
- Record of scientific scholarship and achievement.
- Strong interpersonal skills and ability to collaborate across functions.
- Experience designing and conducting Phase 2 or 3 trials in rheumatologic diseases is preferred.
- Knowledge and skills in clinical judgment, clinical medicine, clinical research management, trial development, data analysis, decision-making, ethical standards, intellectual curiosity, interdisciplinary problem-solving, mentorship, regulatory compliance, scientific consulting and publications, strategic planning, and vaccinology.
- Applicants must reside in the United States or Puerto Rico.
- Able to travel on company business about 20% of the time.
Priekšrocības
- Eligible for an annual bonus.
- May be eligible for long-term incentives.
- Medical, dental, vision, and other insurance coverage for employees and families.
- Retirement benefits, including a 401(k).
- Paid holidays.
- Vacation leave.
- Compassionate and sick leave.
- Hybrid work arrangement.