Top 584 Director of safety sciences Jobs in Somerville Ma

Director Safety Physician
BioNTech AG —Cambridge, MA
- $168,100 - $268,700 a year
- Full-time
- Background check
- Medicine
- Doctor of Philosophy
(Senior-) Director Head of Medical Review (Pharmacovigilance)
BioNTech AG —Cambridge, MA
- $168,100 - $318,300 a year
- Full-time
- Background check
- Medicine
- 7 years
Program Director - Life Sciences
UG2 LLC —Cambridge, MA
- $175,000 a year
- Engineering
- Ability to lift 50 pounds
- Mentoring
Quick Apply
Clinical Scientific Director
Takeda Pharmaceutical —Cambridge, MA
- $177,000 - $278,080 a year
- Full-time
- 3 years
- Business development
- Bachelor's degree
- Paid holidays
- Disability insurance
Director of US Marketing (LEGO Education)
LEGO —Boston, MA
- $169,031 - $253,547 a year
- Online Application
- Hybrid work
- Background check
- Management
- Pass drug screening
- Disability insurance
- Family leave
5d
Director, Safety Sciences
Olema Oncology —Boston, MA
- $235,000 - $255,000 a year
- Medicine
- Office
- Continuous improvement
Quick Apply
Director, Center for Safety Management and Human Factors
US Office of the Secretary of Transportation —Cambridge, MA
- $151,661 - $218,800 a year
- Online Application
- Hybrid work
- Background check
- Pass drug screening
- Travel
- Commuter assistance
- Paid holidays
Senior Operations Director - School of Medicine
Tufts University —Boston, MA
- $158,200 - $237,400 a year
- Hybrid work
- School experience
- Microsoft Excel
- Administrative experience
Director of Residential Dining Operations
Harvard University —Cambridge, MA
- Weekends as needed
- Writing skills
- Pass drug screening
- Public speaking
- Commuter assistance
- Health insurance
Assistant Property Manager
Hines —Boston, MA
- Overtime
- Mid-level
- High school diploma or GED
- Analysis skills
3d
Associate Director, Environmental Health & Safety
Moderna, Inc. —Norwood, MA
- $142,500 - $256,500 a year
- Full-time
- Continuous improvement
- Travel
- Training & development
- Paid time off
- Adoption assistance
Senior Project Manager – Licensed Site Professional (LSP)
Pinchin LLC —North Andover, MA
- 7 years
- Management
- Master's degree
- Health savings account
- Flexible spending account
Quick Apply
Medical Technologist Specialist, Hematology (Days)
Boston Medical Center —Boston, MA
- $40 - $52 an hour
- 8 hour shift
- 5 years
- English
- Bachelor's degree
- Disability insurance
- Health insurance
Quick Apply
Early Childhood/Kindergarten After School Instructor
Brookwood School —Manchester by the Sea, MA
- $18.00 - $18.01 an hour
- Part-time
- School experience
- Classroom
- In-person
Quick Apply
1d
Senior Director / Director Clinical Development, Oncology
BioNTech AG —Cambridge, MA
- $168,100 - $318,300 a year
- Full-time
- Background check
- Medicine
- Mentoring
Executive Medical Director, Oncology Clinical Sciences
Takeda Pharmaceutical —Boston, MA
- $286,900 - $450,890 a year
- Full-time
- Medicine
- 7 years
- Office
- Paid holidays
- Disability insurance
JV Girls Volleyball Head Coach
Pioneer Charter School of Science —Saugus, MA
- $2,500 a year
- Temporary
- School experience
- CPR Certification
- High school
Quick Apply
Head of Automated Small Molecule Synthesis
Takeda Pharmaceutical —Boston, MA
- $177,000 - $278,080 a year
- Full-time
- Bachelor of Science
- Bachelor's degree
- Doctor of Philosophy
- Paid holidays
- Disability insurance
Senior Medical Director, Clinical Science ,NS TAU- Sleep Medicine
Takeda Pharmaceutical —Cambridge, MA
- $257,600 - $404,800 a year
- Full-time
- Hybrid work
- Medicine
- 7 years
- Office
- Paid holidays
- Disability insurance
Medical Director, Clinical Science, Neuroscience TAU- Psychiatry
Takeda Pharmaceutical —Cambridge, MA
- $237,200 - $372,790 a year
- Full-time
- Hybrid work
- Medicine
- Psychiatry
- 5 years
- Paid holidays
- Disability insurance

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Director Safety Physician

BioNTech AG -
Cambridge, MA

Apply Now

Job Details

Full-time
$168,100 - $268,700 a year

Qualifications

FDA submissions
Doctor of Medicine
Committee work
Medicine
Strategic management
Patient safety data management
Pharmacovigilance research
Adverse event reporting
Clinical trial risk management
Safety regulations
Data reporting
Professional development support
Doctor of Philosophy
Team management
Clinical training
Pharmaceutical company experience
Team training
Content development
Business alliance strategy
Compliance documentation
Clinical data report preparation
Mentoring
Safety management experience within healthcare industry
Organizational skills
Regulatory submission editing and review
Biomedical regulatory compliance
Communication with regulatory authorities for clinical trials
Clinical quality assurance standards
Oncology
Senior level

Full Job Description

Cambridge, US; Central Plains, US; Gaithersburg, US; Great Lakes East, US; Mid-Atlantic North, US; Mid-Atlantic South, US; New England, US; New Jersey, US; North Central, US; Pacific Northwest, US | full time | Job ID: 11471

About the role

The Medical Safety Physician (MSP) plays a vital role in supporting the oncology therapeutic area by providing medical safety expertise to one or more study management teams. In collaboration with assigned Safety Scientists, the MSP ensures patient safety throughout the clinical trial process. Responsibilities include contributing to clinical trial protocols, training investigators, assessing safety data (e.g., adverse events of special interest and serious adverse events), determining necessary follow-up actions, and conducting safety signal detection and evaluation. The MSP also ensures compliance with Good Clinical Practice (GCP) and regulatory reporting requirements, while contributing to essential safety documents such as Development Safety Update Reports (DSURs), updates to reference safety information, Investigator Brochures, and Clinical Trial Reports. This position offers the opportunity to take on a strategic role within the Medical Safety Pharmacovigilance (MSPv) department.

Your Contribution

Accountable for the quality performance of one or more safety management team(s) (SMTs)
Oversees safety monitoring, signal management, and the benefit-risk of assigned products through the product life cycle
Identifies and leads escalation, management, and communication of safety inquiries and concerns for assigned products
Formulates and drives the optimal safety strategy for assigned oncology programs in clinical development at the portfolio level
Presents and interacts with Regulatory Authorities on safety matters
Oversees quality content of the safety contributions to clinical and regulatory documents such as briefing book for regulatory authority meetings, investigator’s brochure, clinical study report safety conclusion section, responses to regulatory authority inquiries, and other clinical/regulatory documents as needed
Participates in due diligence for BioNTech’s Licensing /Acquisition initiatives
Represents MSPv in Alliance management projects such as safety data exchange agreement negotiations; or joint oversight committees with development partners, and/or other collaborative development projects
Serves as safety subject matter expert at the portfolio level and is the arbiter for safety-related issues in any of its constituting programs
Ensures activities are performed in compliance with applicable law, global and local regulations, and in accordance with internal and external quality standards
Trains and mentors Safety Physicians and Safety Scientists

A good match

Medical Degree (or internationally recognized equivalent). A MD/PhD and/or certified training in a relevant medical discipline is a plus.
Extensive drug safety/pharmacovigilance experience within the biopharmaceutical/biotechnology industry that includes the development of innovative drugs, BLA/MAA submissions, and advisory committee experience, preferably in immuno-oncology/inflammation therapeutic area(s)
Exposure to, or direct experience in working with Regulatory Agencies on development strategies for innovative oncology products, particularly those of US
Has achieved demonstrable results in a matrix organization and in a multidisciplinary team, experience in implementing GCP standards in clinical trials, in particular safety reporting in compliance with global and local regulations

Your benefits and remuneration:

If the position is filled in the US, the Expected Pay Range is $168,100/year to $268,700/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

Compensation at other locations may vary significantly.

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

How to apply:

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

We are looking forward receiving your application.

Inspired? Become part of #TeamBioNTech.

BioNTech, the story

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!

BioNTech - As unique as you

www.biontech.com

Apply Now

Refine Your Search

director of safety sciences jobs in somerville ma

Director Safety Physician

(Senior-) Director Head of Medical Review (Pharmacovigilance)

Program Director - Life Sciences

Clinical Scientific Director

Director of US Marketing (LEGO Education)

Director, Safety Sciences

Director, Center for Safety Management and Human Factors

Senior Operations Director - School of Medicine

Director of Residential Dining Operations

Assistant Property Manager

Associate Director, Environmental Health & Safety

Senior Project Manager – Licensed Site Professional (LSP)

Medical Technologist Specialist, Hematology (Days)

Early Childhood/Kindergarten After School Instructor

Senior Director / Director Clinical Development, Oncology

Executive Medical Director, Oncology Clinical Sciences

JV Girls Volleyball Head Coach

Head of Automated Small Molecule Synthesis

Senior Medical Director, Clinical Science ,NS TAU- Sleep Medicine

Medical Director, Clinical Science, Neuroscience TAU- Psychiatry

I want to receive the latest job alert for director of safety sciences in somerville ma

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