Top 9386 Sr program Jobs in Boston, Ma

Senior Director, Drug Safety & Pharmacovigilance – Development
Klein Hersh International —Boston, MA
- Email
- Medicine
- 5 years
- Contracts
Director of Development and Communications
Unitarian Universalist Urban Ministry (UUUM) —Roxbury, MA
- $85,000 - $90,000 a year
- Full-time
- Research
- Mid-level
- Office
- Health insurance
- Dental insurance
Quick Apply
5d
Senior Corporate Accountant
ATI Systems/Acoustic Technology, Inc. —Boston, MA
- $130,000 - $150,000 a year
- Full-time
- CPA
- Writing skills
- Office
- Health insurance
- Dental insurance
Quick Apply
12d
Senior Quality Control Analyst I, Bioassay
Ultragenyx Pharmaceutical —Woburn, MA
- $101,500 - $125,400 a year
- Full-time
- Bachelor of Science
- Ability to climb stairs
- Ability to lift 50 pounds
- Gym membership
7d
ESOL Teachers for Adult Education Classes (ESOL Literacy through Intermediate ESOL), Part-Time
City of Cambridge, MA —Cambridge, MA
- $33.19 an hour
- Part-time
- Classroom
- Computer literacy
- Office
- Commuter assistance
- Paid sick time
Operational Area Senior Quality Specialist (Contract) 29503
Vertex Pharmaceuticals —Boston, MA
- $55 - $65 an hour
- Full-time
- Oracle
- Bachelor's degree
- Senior level
4d
Senior Scientist, Stem Cell Biology – Neurobiology (Contract)
Vertex Pharmaceuticals —Boston, MA
- $62 - $65 an hour
- Temporary
- 3 years
- Project management
- Doctor of Philosophy
3d
Sr. Program Lead, Professional Education, CKMH
American Heart Association —Boston, MA
- $84,400 - $113,000 a year
- Full-time
- Remote
- 5 years
- Bachelor's degree
- Fair chance
- Wellness program
- Paid holidays
2d
Sr. Program Manager
Beacon Biosignals —Boston, MA
- Remote
- Psychiatry
- Research
- Neurology
- Paid time off
Quick Apply
Sr. Grant Administrator
The General Hospital Corporation —Cambridge, MA
- $85,800.00 - $115,720.80 a year
- Full-time
- Mid-level
- 3 years
- Bachelor's degree
- Opportunities for advancement
Quick Apply
5d
Sr Program Manager
Textron Systems —Wilmington, MA
- $165,700 - $254,900 a year
- Full-time
- Engineering
- System design
- Travel
- Wellness program
- Paid parental leave
Program Manager
Bicara Therapeutics —Boston, MA
- $147,000 - $180,000 a year
- Full-time
- Hybrid work
- Mid-level
- Office
- Analysis skills
Sr Program Manager
Chewy —Boston, MA
- $129,500 - $207,000 a year
- Full-time
- 6 years
- Research
- SQL
- Paid holidays
- Health insurance
6d
Sr Research Development Officer
Northeastern University —Boston, MA
- $87,785.00 - $123,998.75 a year
- Full-time
- Doctoral degree
- 3 years
- Master's degree
- Health insurance
- Dental insurance
Senior Cohort Program Manager
Northeastern University —Boston, MA
- $66,850.00 - $94,427.50 a year
- Full-time
- Hybrid work
- Mid-level
- Analysis skills
- University
- Health insurance
- Dental insurance
Senior Program Manager
Harvard University —Boston, MA
- Full-time
- Hybrid work
- 5 years
- Word processing
- Writing skills
- Commuter assistance
- Health insurance
9d
Workforce Development Program Manager
Dana-Farber Cancer Institute —Brookline, MA
- $81,070 - $94,070 a year
- Full-time
- Hybrid work
- Mid-level
- Bachelor's degree
- Computer skills
9d
Health Equity Program Manager
Beth Israel Lahey Health —Charlestown, MA
- $79,997 - $119,995 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Customer service
10d
Senior Analyst, Healthcare
Community Care Cooperative —Boston, MA
- $102,561 - $125,638 a year
- Full-time
- 7 years
- Mid-level
- SQL
Quick Apply
13d
Perspective Editor
Massachusetts Medical Society —Boston, MA
- From $125,000 a year
- 7 years
- Bachelor's degree
- Military encouraged
- Paid holidays
- Health insurance
Quick Apply

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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

sr program jobs in boston, ma

Senior Director, Drug Safety & Pharmacovigilance – Development

Director of Development and Communications

Senior Corporate Accountant

Senior Quality Control Analyst I, Bioassay

ESOL Teachers for Adult Education Classes (ESOL Literacy through Intermediate ESOL), Part-Time

Operational Area Senior Quality Specialist (Contract) 29503

Senior Scientist, Stem Cell Biology – Neurobiology (Contract)

Sr. Program Lead, Professional Education, CKMH

Sr. Program Manager

Sr. Grant Administrator

Sr Program Manager

Program Manager

Sr Program Manager

Sr Research Development Officer

Senior Cohort Program Manager

Senior Program Manager

Workforce Development Program Manager

Health Equity Program Manager

Senior Analyst, Healthcare

Perspective Editor

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