Top 105 Principal scientist Jobs in Reading, Ma

Principal Clinical Trial Manager
TransMedics, Inc. —Andover, MA
- $137,100 - $193,700 a year
- Full-time
- Bachelor of Science
- Office
- Master's degree
- Employee stock purchase plan
- Disability insurance
Quick Apply
Principal Scientist II, Immunology
ModeX Therapeutics, Inc. —Weston, MA
- $207,000 - $222,000 a year
- Management
- 11+ years
- Master's degree
Principal Scientist, Biology (Immunology)
C4 Therapeutics Inc —Watertown, MA
- $187,632 - $207,383 a year
- Full-time
- Doctor of Philosophy
- Mentoring
- Senior level
Quick Apply
Principal Scientist -Emerging Obesity Mechanisms
Novo Nordisk —Lexington, MA
- $180,000 - $235,000 a year
- Master's degree
- Bachelor's degree
- Doctor of Philosophy
- Disability insurance
- Health insurance
5d
Principal Scientist, Bioanalytics
Merck KGaA —Billerica, MA
- $126,900 - $215,400 a year
- English
- Doctor of Philosophy
- Neurology
- Health insurance
- Paid time off
Senior Principal Toxicologist
Keurig Dr Pepper —Burlington, MA
- $130,700 - $190,000 a year
- Email
- Doctor of Philosophy
- Travel
- Senior level
- Mileage reimbursement
- Paid parental leave
Principal AI Scientist
Pristine Infotech —Boston, MA
- Email
- Computer science
- Computer Science
- SQL
Principal Scientist II - Pharmacology
Novartis —Cambridge, MA
- $126,000 - $234,000 a year
- Full-time
- Management
- 5 years
- Analysis skills
- Health insurance
- 401(k) matching
Principal Scientist, DMPK
Merck —Boston, MA
- $176,200 - $277,300 a year
- Full-time
- 6 years
- Master's degree
- Doctor of Philosophy
- Paid holidays
- Health insurance
12d
Biotechnology Principal Investigator
STR —Woburn, MA
- $220,000 - $280,000 a year
- Email
- 5 years
- Bachelor of Science
- Business development
Principal Scientist, Process Development (Expression Systems)
Moderna, Inc. —Norwood, MA
- $142,500 - $256,500 a year
- Full-time
- 5 years
- Bachelor of Science
- Office
- Health insurance
- Paid time off
Principal Machine Learning Scientist
Bayer —Cambridge, MA
- $128,000 - $192,000 a year
- 5 years
- Analysis skills
- Doctor of Philosophy
- Health insurance
- Dental insurance
Principal AI Research Scientist (HPE Labs)
Hewlett Packard Enterprise —Andover, MA
- $172,000 - $349,000 a year
- Full-time
- Computer Science
- 5 years
- Office
10d
Principal Scientist, TCR Optimization
Moderna, Inc. —Cambridge, MA
- $142,500 - $256,500 a year
- Full-time
- 5 years
- Office
- Analysis skills
- Paid time off
- Adoption assistance
Principal Scientist, Protein Design
Moderna, Inc. —Cambridge, MA
- $142,500 - $256,500 a year
- Full-time
- 5 years
- Doctor of Philosophy
- Mentoring
- Health insurance
- Paid time off
Principal Research Associate
Deep Genomics —Cambridge, MA
- $115,000 - $135,000 a year
- Full-time
- Bachelor of Science
- Mid-level
- Bachelor's degree
- Health insurance
- Dental insurance
Quick Apply
Senior Scientist II/Principal Scientist, Molecular Cloning Technologies
Flagship Pioneering, Inc. —Cambridge, MA
- $143,000 - $214,500 a year
- Data analysis skills
- Doctor of Philosophy
- Mentoring
- Retirement plan
Principal Scientist II, Translational Biomarker Strategy Lead
Novartis —Cambridge, MA
- $114,100 - $211,900 a year
- Full-time
- Medicine
- 7 years
- Doctor of Philosophy
- Paid parental leave
- Parental leave
Senior Principal Pharmacovigilance Scientist
Takeda Pharmaceutical —Cambridge, MA
- $137,000 - $215,270 a year
- Full-time
- Mentoring
- Organizational skills
- Senior level
- Paid holidays
- Disability insurance
Principal Research Scientist
Harvard University —Cambridge, MA
- Full-time
- 5 years
- Office
- University
- Commuter assistance
- Health insurance

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Principal Clinical Trial Manager

TransMedics, Inc. -
Andover, MA

Quick Apply

Job Details

Full-time
$137,100 - $193,700 a year

Benefits

Employee stock purchase plan
Disability insurance
Health insurance
Dental insurance
401(k)
Flexible spending account
Paid time off
Vision insurance
Pet insurance

Qualifications

Bachelor's degree
Pharmaceutical company experience
Biomedical regulatory compliance
Communication with regulatory authorities for clinical trials
IRB compliance
Ethical review application preparation

Full Job Description

Job Description:

POSITION SUMMARY

The Principal Clinical Trial Manager provide leadership in the development of clinical trial activities and ensure that clinical trials are completed in time and with the highest quality with thoughtful delegation of study related tasks and assignments.

RESPONSIBILITIES

This position is responsible for, but not limited to, the following:

Leading the process of pre and post market clinical trials for FDA by employing effective organizational strategies and reviewing and presenting the results using rigorous clinical procedures
Responsible for creating study specific templates across all programs
Responsible for managing the planning, implementation, and tracking of the clinical monitoring process with CRAs
Provide oversight of drafting all annual and bi-annual pre and post market reports to FDA in collaboration with the regulatory team
Lead all clinical site interactions (including assistance with IRB/EC applications, contract negotiations, enrollment tracking, clinical trial material and clinical supply requests, issue resolution, etc.)
Own and manage all trial start-up, conduct, and close-out activities according to industry and corporate standards
Lend expertise to the preparation of key clinical documents in conjunction with other team members (e.g. protocols, informed consent, amendments, CRF’s, training materials, project plans, monitoring plans, data plans, statistical analysis plans, summary reports, etc.)
Establish professional rapport and engage in frequent communication with investigational site personnel in order to keep study on-track
Track internal metrics, timelines and budgets
Communicate trial status to trial team
Prepare and present trial specific updates to management
Oversee and participate in monitoring activities at clinical trial sites to ensure adherence to GCP and ICH guidelines, regulatory requirements, SOPs, protocols and take ownership for data completion and accuracy
Interact with data management personnel to plan, monitor, and execute data analyses
Support applications and technical files as needed
Collaborate with project specific committees (e.g., DSMB, CEC)
Assist with preparation for investigators’ meetings
Work with vendors as needed
Perform other TransMedics tasks and duties as assigned/required.

MANAGEMENT RESPONSIBILITIES

This position manages the following positions on a daily basis.

This position will not have management responsibilities.

PHYSICAL ATTRIBUTES

None (Standard office environment).
Travel up to 25% of the time

MINIMUM QUALIFICATIONS

BA/BS in Science, Life Sciences or relevant field
8-10 years’ pharmaceutical drug development, biotech or CRO industries experience monitoring and managing clinical trials (cardiovascular therapeutic indications preferred); or equivalent combination of education and experience. Proven expertise in executing IRB/EC submissions and approvals

PREFERRED QUALIFICATIONS

Masters in Science, Life Sciences or relevant field; or equivalent combination of education and experience
Experience in medical device (strongly preferred),
Outstanding track record leading large complex global clinical trials for medical device products in different phases of the product cycle
Broad and deep knowledge of device clinical trial documentation requirements including monitoring requirements, FDA regulations, and operational aspects of clinical trials
Experience complying with GCP, ICH, ISO and FDA regulatory requirements
Proven ability to identify operational issues and proactively recommend and implement strategies to resolve problems
In-depth knowledge of adverse event investigation, analysis, and reporting procedures and standards
Willing to be held accountable for deliverables
Must be highly organized and detail oriented
Experience interfacing with multiple vendors/contractors
Proven ability to handle multiple projects and changing priorities
Must be results-driven and exhibit a sense of urgency
Clear and concise in verbal and written communication, fosters smooth flow of timely and relevant information
Strong initiative and positive attitude
Ability to support and build collaborative relationships both internally and externally
Demonstrated ability to make timely decisions using sound judgment
Experience with electronic data capture (EDC)
Experience in clinical budget planning and management
Influential & assertive communication skills
Excellent leadership skills
Good record keeping skills
Ability to motivate
Self Confidence
Ability to think Out-of-the-box
Problem solving skills
Conflict management skills

Every Organ Wasted is a Life Not Saved.
TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes.

Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health.

Maximize your potential at TransMedics, Inc.
www.TransMedics.com

TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $137,100.00 – $193,700.00, which represents the company’s current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. This role may also be eligible for bonuses, equity, and a comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history.

Employee Benefit:

Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA

Dental

Vision

Healthcare Flexible Spending Account

Dependent Care Flexible Spending Account

Short Term Disability

Long Term Disability

401K Plan

Pet insurance

Employee Stock Purchase Plan

TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.

Quick Apply

Refine Your Search

principal scientist jobs in reading, ma

Principal Clinical Trial Manager

Principal Scientist II, Immunology

Principal Scientist, Biology (Immunology)

Principal Scientist -Emerging Obesity Mechanisms

Principal Scientist, Bioanalytics

Senior Principal Toxicologist

Principal AI Scientist

Principal Scientist II - Pharmacology

Principal Scientist, DMPK

Biotechnology Principal Investigator

Principal Scientist, Process Development (Expression Systems)

Principal Machine Learning Scientist

Principal AI Research Scientist (HPE Labs)

Principal Scientist, TCR Optimization

Principal Scientist, Protein Design

Principal Research Associate

Senior Scientist II/Principal Scientist, Molecular Cloning Technologies

Principal Scientist II, Translational Biomarker Strategy Lead

Senior Principal Pharmacovigilance Scientist

Principal Research Scientist

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