Top 532 Senior principal scientist Jobs in Melrose Ma

Senior Director, Drug Safety & Pharmacovigilance – Development
Klein Hersh International —Boston, MA
- Email
- Medicine
- 5 years
- Contracts
Physics Expert (Professor / Principal Investigator) – AI Trainer
micro1 —Boston, MA
- $80 - $160 an hour
- Contract
- Remote
- Doctor of Philosophy
- Senior level
- Leadership
- Flexible schedule
Senior Research Scientist –Flammability and Fire Dynamics
FM —Norwood, MA
- $121,000 - $173,000 a year
- Full-time
- Math
- Doctor of Philosophy
- Senior level
- 401(k)
- Tuition reimbursement
Co-Director of Acorn Center for Early Education and Care
Boston Chinatown Neighborhood Center —Boston, MA
- $65,000 - $90,000 a year
- Full-time
- Background check
- Classroom
- 5 years
- Disability insurance
- Health insurance
Quick Apply
Senior Research Scientist – Battery and Data Center Safety
FM —Norwood, MA
- $121,000 - $173,000 a year
- Full-time
- Math
- Doctor of Philosophy
- Senior level
- 401(k)
- Tuition reimbursement
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 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
Senior Research Scientist - AI Trainer
DataAnnotation —Lynn, MA
- $50 - $100 an hour
- Part-time
- Remote
- Computer Science
- Writing skills
- English
- Flexible schedule
Quick Apply
Sr. Manager, R&D
Getinge —Boston, MA
- $160,000 a year
- Full-time
- Engineering
- Critical & Intensive Care
- Travel
- Commuter assistance
- Disability insurance
Sr. Research Associate- ESI Flow Cytometry
Yoh, A Day & Zimmermann Company —Waltham, MA
- $28 - $40 an hour
- Contract
- Bachelor of Science
- Mid-level
- Bachelor's degree
- Health savings account
- Disability insurance
Quick Apply
Sr. Quality Control Analyst
Pace Analytical Life Sciences —Waltham, MA
- $105,000 - $120,000 a year
- Full-time
- Microsoft Office
- 3 years
- Master's degree
- Wellness program
- Health savings account
2d
Sr. Quality Control Analyst
Pace Analytical Life Sciences —Waltham, MA
- $35 - $50 an hour
- Full-time
- English
- Master's degree
- Bachelor's degree
- Wellness program
- Health savings account
Senior/Principal Scientist Cell Based Potency Assay
Takeda Pharmaceutical —Lexington, MA
- $154,400 - $242,550 a year
- Full-time
- Bachelor of Science
- 3 years
- Bachelor's degree
- Paid holidays
- Disability insurance
Senior/Principal Scientist, Analytical Cell Line Engineering and Bioassay Development
Takeda Pharmaceutical —Lexington, MA
- $154,400 - $242,550 a year
- Weekends as needed
- 11+ years
- Master's degree
- Bachelor's degree
- Paid holidays
- Disability insurance
Senior Principal Scientist, Analytical Sciences
Eli Lilly —Watertown, MA
- $71,250 - $187,000 a year
- Full-time
- 7 years
- Bachelor of Science
- Analysis skills
- Health insurance
- Dental insurance
Senior Scientist or Principal Scientist, Targeted Proteomics
Kymera Therapeutics —Watertown, MA
- $115,000 - $215,000 a year
- Bachelor of Science
- Bachelor's degree
- Doctor of Philosophy
Quick Apply
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
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 / Senior Principal Scientist, Small Molecule Therapeutics
Lila Sciences —Cambridge, MA
- $156,000 - $246,000 a year
- Bachelor of Science
- Bachelor's degree
- Machine learning
Quick Apply
Senior Principal Scientist - Translational Muscle Biology
UCB —Cambridge, MA
- Presentation skills
- Doctor of Philosophy
- Neurology

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Senior Director, Drug Safety & Pharmacovigilance – Development

Klein Hersh International -
Boston, MA

Apply Now

Job Details

Qualifications

FDA submissions
Managerial strategic planning
Pharmacovigilance research
Adverse event reporting
Clinical trial risk management
Safety regulations
Lean
Investigational new drug (IND) applications
Supplier relationship improvement
ICH guidelines
Vendor compliance management
Vendor relationship management
Contracts
Vendor contract management
Regulatory submission editing and review
Communication with regulatory authorities for clinical trials
Clinical quality assurance standards
Project contract management
Oncology
Clinical program risk management
Cross-functional team management
Cross-functional communication
Senior leadership

Full Job Description

Contact: Kevin Mednick
Phone: (215) 658-1379

Position Overview

Our client is a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large patient populations, including those not addressed by existing platform technologies.

This role will serve as the safety expert across programs and drive safety excellence with the clinical development organization. In collaboration with internal and external partners, you will design and implement best-in-class safety practices to ensure global compliance, support health authority submissions, and protect patient well-being and safety.

Key Responsibilities:

Clinical Safety Leadership

Act as the drug safety lead for one or more clinical-stage assets, providing clinical oversight and proactive safety surveillance in collaboration with global program/clinical teams.
Design, direct and conduct ongoing safety surveillance of company drug products using internal and external resources (e.g. CROs/vendors) to ensure delivery of high-quality Drug Safety services, including oversight of patient safety in all ongoing clinical trials. This includes the medical review of (AEs) and Serious AEs (SAEs).
Provide strategic planning, implementation, and management of Drug Safety activities to support the clinical development of company products.
Serve as the clinical safety expert for all assigned products at all stages of clinical development. As needed, provide hands-on oversight of all clinical safety services including review of medical coding of AEs, concomitant medications, and processing of SAEs (review, query generation and resolution, and preparation of case narratives) through the entire lifecycle.
Establish and conduct signal management procedures including signal evaluation reports and recommendations for risk characterization.
Lead the Risk Management Team (RMT) meetings for review of safety data and AE profile, including production of any associated materials (e.g., aggregate reports, charter).
Provide medical review of AE reports to ensure the accuracy, integrity and completeness of information entered in the safety database.
Contribute critical medical input to clinical documents, including protocols, investigator brochures, and informed consents.
Review and approve safety data for regulatory submissions, aggregate safety reports (e.g., DSURs, PSURs/PBRERs, RMPs), and safety sections of CTD documents.
Provide medical expert safety review input for critical documents for clinical development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs)

Function Building & Operational Oversight

Build and own the internal Drug Safety & PV function with a focus on scalability, agility, and regulatory excellence.
Oversee day-to-day Safety Operations via a partially outsourced model; manage and optimize PV vendor relationships.
Ensure the quality and timeliness of AE processing, safety database management, MedDRA coding, and global reporting.
Develop and maintain PV policies, SOPs, safety governance frameworks, and inspection readiness plans.

Strategic Collaboration & Influence

Serve as a key clinical safety representative on Clinical Study Teams and global program teams (as needed).
Partner closely with Clinical Development, Regulatory Affairs, Quality, and DMPK to align on safety strategies and data interpretations.
Support safety-related interactions with global health authorities, including preparation for and participation in regulatory meetings, inspections or audits.
Bring a solutions-oriented mindset to evolving internal processes and organizational needs as the company scales.

Key Requirements:

MD or equivalent medical degree required; specialty training in oncology.
Strong desire to be part of a mission‐oriented company leading transformative change for patients.
Proven demonstration of transparent communication and fostering open and diverse debate.
Ability to work with agility and manage ambiguity.
Personifies positive energy and exemplifies respect.
Outstanding interpersonal and communication skills, with the ability to foster trust, influence stakeholders, and operate cross-functionally.
A blend of strategic acumen and operational know-how, able to pivot between high-level planning and detailed execution.
5-7+ years of biopharmaceutical industry experience in pharmacovigilance and clinical safety, with demonstrated success in a leadership capacity.
Proven experience managing pharmaco-vigilance in a partially or fully outsourced model, including vendor oversight and contract management.
Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; expertise in global safety regulations.
Expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities
In-depth knowledge of global PV regulations and good pharmacovigilance practice requirements, with direct experience in INDs, NDAs/BLAs/MAAs, and other regulatory submissions.
A track record of building or scaling safety functions, especially in lean, high-growth environments.

Location: Boston/RTL/Remote

Location(s)

Boston, MA

If interested, please send a MS Word version of your resume to [email protected]

Apply Now

Refine Your Search

senior principal scientist jobs in melrose ma

Senior Director, Drug Safety & Pharmacovigilance – Development

Physics Expert (Professor / Principal Investigator) – AI Trainer

Senior Research Scientist –Flammability and Fire Dynamics

Co-Director of Acorn Center for Early Education and Care

Senior Research Scientist – Battery and Data Center Safety

Senior Principal Toxicologist

Principal Clinical Trial Manager

Senior Research Scientist - AI Trainer

Sr. Manager, R&D

Sr. Research Associate- ESI Flow Cytometry

Sr. Quality Control Analyst

Sr. Quality Control Analyst

Senior/Principal Scientist Cell Based Potency Assay

Senior/Principal Scientist, Analytical Cell Line Engineering and Bioassay Development

Senior Principal Scientist, Analytical Sciences

Senior Scientist or Principal Scientist, Targeted Proteomics

Senior Principal Pharmacovigilance Scientist

Senior Scientist II/Principal Scientist, Molecular Cloning Technologies

Principal / Senior Principal Scientist, Small Molecule Therapeutics

Senior Principal Scientist - Translational Muscle Biology

I want to receive the latest job alert for senior principal scientist in melrose ma

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