BioNTech SE
(Senior) Director Biostatistics(m/w/x)
Full-timeOn-siteSenior
Mainz, München
from USD 198,900 - 298,300 / year
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BIBioNTech SE
Director Safety Physician(m/w/x)
Mainz, München
from USD 168,100 - 268,700 / year
Full-timeOn-siteSenior
Nejo AI Summary
Medical safety expertise for oncology drug development, including clinical trial protocol contributions and investigator training. MD/PhD and extensive drug safety experience required. Annual bonus and equity.
Requirements
- Medical Degree or equivalent
- MD/PhD and/or certified training in medical discipline (plus)
- Extensive drug safety/pharmacovigilance experience
- Experience in innovative drug development
- Experience with BLA/MAA submissions
- Advisory committee experience
- Experience in immuno-oncology/inflammation therapeutic areas (preferred)
- Exposure to regulatory agencies on development strategies
- Direct experience with regulatory agencies on development strategies
- Experience with innovative oncology product development strategies
- Experience with US regulatory agencies (particularly)
- Demonstrable results in matrix organization
- Demonstrable results in multidisciplinary team
- Experience implementing GCP standards in clinical trials
- Experience with safety reporting compliance
Tasks
- Support oncology therapeutic area with medical safety expertise
- Collaborate with Safety Scientists to ensure patient safety
- Contribute to clinical trial protocols
- Train investigators on safety procedures
- Assess safety data, including adverse events and serious adverse events
- Determine necessary follow-up actions for safety concerns
- Conduct safety signal detection and evaluation
- Ensure compliance with Good Clinical Practice (GCP) and regulatory reporting
- Contribute to Development Safety Update Reports (DSURs)
- Update reference safety information
- Revise Investigator Brochures
- Prepare Clinical Trial Reports
- Oversee safety monitoring and signal management
- Manage benefit-risk of assigned products throughout the product life cycle
- Identify and lead escalation of safety inquiries and concerns
- Formulate and drive optimal safety strategy for oncology programs
- Present and interact with Regulatory Authorities on safety matters
- Oversee quality content of safety contributions to clinical and regulatory documents
- Participate in due diligence for BioNTech’s Licensing/Acquisition initiatives
- Represent MSPv in Alliance management projects
- Negotiate safety data exchange agreements
- Serve on joint oversight committees with development partners
- Ensure activities comply with applicable laws and regulations
- Train and mentor Safety Physicians and Safety Scientists
Work Experience
- approx. 4 - 6 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Bonuses & Incentives
- Annual bonus
Competitive Pay
- Equity
- Competitive remuneration packages
Corporate Discounts
- Variety of benefits
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech SE and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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BIBioNTech SE
Director Safety Physician(m/w/x)
Mainz, München
from USD 168,100 - 268,700 / year
Full-timeOn-siteSenior
Nejo AI Summary
Medical safety expertise for oncology drug development, including clinical trial protocol contributions and investigator training. MD/PhD and extensive drug safety experience required. Annual bonus and equity.
Requirements
- Medical Degree or equivalent
- MD/PhD and/or certified training in medical discipline (plus)
- Extensive drug safety/pharmacovigilance experience
- Experience in innovative drug development
- Experience with BLA/MAA submissions
- Advisory committee experience
- Experience in immuno-oncology/inflammation therapeutic areas (preferred)
- Exposure to regulatory agencies on development strategies
- Direct experience with regulatory agencies on development strategies
- Experience with innovative oncology product development strategies
- Experience with US regulatory agencies (particularly)
- Demonstrable results in matrix organization
- Demonstrable results in multidisciplinary team
- Experience implementing GCP standards in clinical trials
- Experience with safety reporting compliance
Tasks
- Support oncology therapeutic area with medical safety expertise
- Collaborate with Safety Scientists to ensure patient safety
- Contribute to clinical trial protocols
- Train investigators on safety procedures
- Assess safety data, including adverse events and serious adverse events
- Determine necessary follow-up actions for safety concerns
- Conduct safety signal detection and evaluation
- Ensure compliance with Good Clinical Practice (GCP) and regulatory reporting
- Contribute to Development Safety Update Reports (DSURs)
- Update reference safety information
- Revise Investigator Brochures
- Prepare Clinical Trial Reports
- Oversee safety monitoring and signal management
- Manage benefit-risk of assigned products throughout the product life cycle
- Identify and lead escalation of safety inquiries and concerns
- Formulate and drive optimal safety strategy for oncology programs
- Present and interact with Regulatory Authorities on safety matters
- Oversee quality content of safety contributions to clinical and regulatory documents
- Participate in due diligence for BioNTech’s Licensing/Acquisition initiatives
- Represent MSPv in Alliance management projects
- Negotiate safety data exchange agreements
- Serve on joint oversight committees with development partners
- Ensure activities comply with applicable laws and regulations
- Train and mentor Safety Physicians and Safety Scientists
Work Experience
- approx. 4 - 6 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Bonuses & Incentives
- Annual bonus
Competitive Pay
- Equity
- Competitive remuneration packages
Corporate Discounts
- Variety of benefits
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech SE and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
BioNTech SE
Industry
Pharmaceuticals
Description
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
Not a perfect match?
- BioNTech SE
(Senior) Director Biostatistics(m/w/x)
Full-timeOn-siteSeniorMainz, Münchenfrom USD 198,900 - 298,300 / year - BioNTech SE
Senior Director, Safety Sciences Lead(m/w/x)
Full-timeOn-siteSeniorMainz, München - BioNTech SE
Manager, Safety Data Analyst(m/w/x)
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Associate Director Biostatistics(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Associate Director Scientific/Medical Writing(m/w/x)
Full-timeOn-siteSeniorMainz