Clinical Data and Biomarker Specialist *PC 881
Waltham, MA 
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Posted 16 days ago
Job Description
Description

Are you ready to partake in the personalized medicine revolution? Miltenyi Biomedicine is a new division of the Miltenyi Biotec family focused on bringing customized cancer treatments and regenerative therapies to patients worldwide. Miltenyi Biomedicine serves an essential role in the Miltenyi Group, bridging the crucial divide from laboratory bench to patient bedside, ensuring that our innovations deliver direct benefits to those contending with some of today's most challenging diseases. Our clinical research and development team is dedicated to tailoring cell and gene therapies to individual patients, specifically working on treatments for hematological cancers using chimeric antigen receptor (CAR) T cell technology. The group is also researching regenerative therapies for Alzheimer's disease, Parkinson's disease, and diabetes in the elderly.

Clinical Data and Biomarker Specialist Waltham, MA - Remote/Flex

Your Tasks:

As a Clinical Data and Biomarker Specialist, at the Miltenyi Biomedicine (MB) you will serve as a member of the clinical development team. You will significantly contribute to development of clinical trials including the focus on biomarker plans development and data review and interpretation. Participate in meetings, reviews, discussions and other interactions regarding development and analysis of clinical trials.

Essential Duties and Responsibilities:

  • Strategically plan for selection and optimization of the clinical biomarkers evaluations supporting clinical development within the therapeutic areas of the MBM interest.
  • Provide review and analysis of company sponsored clinical studies for the assigned pharmaceutical products.
  • Functionally contribute to planning of clinical trials acting as the expert for a scientific strategy, including detailed cellular kinetics and biomarkers plan, correlation with clinical and pharmaceutical data.
  • Contribute functionally to Medical Team activities including designing of the study protocols and supporting documents, advisory boards, investigator meetings, external strategy forums, and other key internal and external focus meetings as necessary.
  • Identify and develop KOLs and relevant vendors relationships in the clinical biomarker research space.
  • Act as the company's scientific consultant and as the biomarker expert to internal stakeholders.
  • Stay abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for therapeutic areas of the MBM interest.
  • Maintain scientific knowledge in translational research aspects of product development and participate in competitive intelligence assessments.
  • Represent Clinical Development in sub-teams relevant to the translational, biomarker and clinical data matters.
  • Support the completion and submission of regulatory filings and other regulatory documentation.
  • Contribute to development of key clinical and translational presentations, publications, both internally and externally.
  • Identify and develop vendors in the translational space, cellular kinetics, biomarkers, pathology, laboratory parameters etc.
  • Support clinical trials analyses for biomarkers, cellular kinetics, translational data as well as clinical data.
  • Collaborate with Research teams to bridge non-clinical data into clinical development, and establish credible, clinically based biomarker, and cellular kinetics plans, as well as clinical data review.

Requirements:

  • Master's degree with 5 years or PhD (Preferred) with 2 years or other relevant scientific degree, in the area of cell therapy, molecular biology or similar; or a combination of education of experience.
  • Expertise in all aspects of biomarker science i.e. genetics, genomics, molecular and cellular, digital devices, imaging and data sciences; cellular kinetics.
  • Working knowledge of clinical data, both at efficacy and safety level.
  • Working knowledge of bioanalytical assays developments to meet regulatory requirements.
  • Deep understanding of cell therapy, oncology diseases that can be applied to questions of diagnosis, biomarker development and treatment monitoring strongly preferred Experience performing similar role within a pharmaceutical/biotechnology research company, clinical research organization or academic medical center.
  • Working knowledge of biostatistics, bioinformatics, computational biology.
  • Experience in preparation and delivery of scientific presentation, abstracts and manuscripts development and documents supporting clinical development.
  • Remote/Flex

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature controlled, handicap-accessible facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in an office environment. This job requires the person to occasionally travel to visit other sites.

As a global team of over 3,000 diverse innovators, we are united by a shared vision to advance research and improve patient care worldwide. Our mission transcends mere scientific discovery; we are on a quest to unravel the complexities of biology and transform them into tangible solutions that propel research to unprecedented heights.

Here, you will contribute to work that is breaking barriers, blending the wonders of biological discovery with the pursuit of well-being for all. Join Miltenyi Biotec and immerse yourself in an environment where you can play an integral role in improving patient care from bench to bedside.

Miltenyi Biomedicine, Inc. is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity

Miltenyi Biotec, Inc. participates in E-Verify.






Miltenyi Biotec is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
Open
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