Senior Clinical Research Scientist

The businesses of Merck KGaA, Darmstadt, Germany•Billerica, MA

47d•$131,300 - $216,600•Hybrid

About The Position

This role is for a Senior Clinical Research Scientist (CRS) who will serve as a subject matter expert and strategic partner to the Medical Lead, providing scientific, clinical, and operational input across early and late-stage clinical development programs. The company, EMD Serono, is seeking curious minds to join their Healthcare team, which focuses on developing medicines, intelligent devices, and innovative technologies in therapeutic areas such as Oncology, Neurology, and Fertility. The Healthcare team works collaboratively across 6 continents with a passion for helping patients at every stage of life, fostering a diverse, inclusive, and flexible working culture with opportunities for personal development and career advancement.

Requirements

Master's Degree
Minimum of 3 years of experience in product and clinical development
At least 5 years in a comparable role within the pharmaceutical, biopharmaceutical, or healthcare industry
Ability to work both independently and collaboratively on tasks and projects of increasing complexity, with a commitment to scientific rigor
Solid knowledge of regulatory requirements, including ICH-GCP guidelines
Strong aptitude for interpreting and integrating complex data sets, including clinical safety and efficacy data, pharmacokinetics, biomarker data, and next-generation sequencing data
High level of medical and clinical knowledge, with hands-on experience in clinical development and operations, including the ability to monitor laboratory and other clinical trial data
Excellent communication and presentation skills, with the ability to contribute to abstracts and publications and to adapt messaging effectively for a variety of audiences

Nice To Haves

Advanced degree in life sciences (e.g., PharmD, PhD, or MPH)
Postdoctoral experience
Proven track record of successfully leading or making significant contributions to clinical trials, with Phase III experience strongly preferred
Educational and/or professional background in immunology is strongly desirable
Ability to rapidly develop a working scientific knowledge across different therapeutic areas

Responsibilities

Contribute to data interpretation, study designs, regulatory and study documents, and publication efforts
Provide scientific input into pipeline programs
Conduct Medical Monitoring and Medical Data Review activities in close collaboration with the Medical Lead, including oversight of Medical Monitoring activities performed by contracted vendors
Engage and collaborate with a multi-disciplinary, global team, ensuring that scientific, clinical, and other relevant topics are appropriately considered in the context of highly complex data findings