Senior Director Clinical Development - Late Stage & ADC Oncology
Mainz, Rhineland-Palatinate, Germany · On-site
$168k–$318k/yr
Senior+$2.0B raised
Munich, Germany; London, United Kingdom; Mainz, Germany | full time | Job ID: 11648 About the Role As a (Senior) Director of Clinical Development at BioNTech, you will collaborate closely with the VP of Clinical Developm…
Skills: Clinical trial design, Immuno-oncology, Oncology, Regulatory approval, Clinical development
南通,中国 | 全职 | Job ID: 11655 About the role: 该岗位将全面负责公司原液生产车间(包括上游细胞培养和下游纯化)的运营管理、团队建设和战略规划。需要确保所有生产活动严格遵循cGMP法规、公司SOP和质量标准,安全、高效地完成临床及商业化阶段的生产任务,并持续推动生产工艺的优化和创新。 This role will oversee operational management, team deve…
Skills: Drug substance production, Cell culture, Downstream purification, cGMP, Team management
Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany; New Jersey, US | full time | Job ID: 11307 About the Role At BioNTech, we are united by a shared mission to harness the power of science and innova…
Cambridge, US | full time | Job ID: 11136 The Manager, US Corporate Events, plays a key role in designing and delivering events that showcase BioNTech’s innovations, culture, and strategic priorities. The role is respons…
中国,上海 | 全职 | Job ID: 11584 Position Summary: Supports and oversees the proactive and risk-based quality strategy implementation in the drug research and development activities Your main responsibilities are: The Associat…
Skills: Good Clinical Practice (GCP), Quality Assurance, Regulatory Inspection Management, Quality Management Systems (QMS), CAPA Management
Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany | full time | Job ID: 11273 About the Role: The Scientific Communications Leader (SCL) is a strategic leadership role responsible for defining and d…
Munich, Germany | full time | Job ID: 11640 As a Project Manager in the CMC Project Management Team at BioNTech, you will be part of cross-functional project teams in a variety of late phase CMC development projects that…
Shanghai, China | full time | Job ID: 11670 Purpose: At BioNTech’s Business Development and Business Alliance team you will participate in business development transactions and business alliances activities of the compan…
Skills: Business development, Alliance management, Strategic partnerships, Licensing agreements, Due diligence
Mainz, Deutschland | Vollzeit | Job ID: 11616 * Bitte beachte, dass diese Position befristet für zwei Jahre zu besetzten ist. Deine Rolle: Als Manager Hygiene Management Mainz (m/w/d) bist du die Schnittstelle zwischen d…
Skills: Hygiene management, GMP, GCLP, CAP/CLIA, GDP
Cambridge, US; Gaithersburg, US; New Jersey, US | full time | Job ID: 11654 About the Role: At BioNTech, we are committed to revolutionizing medicine through cutting-edge science and innovation. As Associate Director, Cl…
Skills: Clinical pharmacology, Pharmacometrics, Pharmacokinetics, Pharmacodynamics, Drug development
Munich, Germany | full time | Job ID: 11640 As a Project Manager in the CMC Project Management Team at BioNTech, you will be part of cross-functional project teams in a variety of late phase CMC development projects that…
南通,中国 | 全职 | Job ID: 11660 About the role: As China SHE Associate Director, you will play a key role in the safety, health and environment for employees and company by supporting SS&E head on operation and overseeing the…
Skills: Safety, Health and Environment (SHE), Regulatory compliance, Risk management, Incident investigation, Vendor management
Manager, Global Quality Intelligence & Product Quality Complaints (remote)
Gaithersburg, Maryland, United States · Remote OK
$114k–$182k/yr
Senior$2.0B raised
New Jersey, US; Cambridge, US; Gaithersburg, US | full time | Job ID: 11629 About the Role: As a Manager in Global Quality Intelligence & Product Quality Complaints, you will be responsible for establishing, implementing…
Cambridge, US | full time | Job ID: 11672 The ideal candidate will work in a highly collaborative and cross-functional team to develop antibody drug conjugates (ADCs). The position requires close collaborations with vari…
Skills: Organic chemistry, Protein degraders, Molecular glues, Antibody drug conjugates, Drug discovery
Associate Director, China Site Service & Engineering Project Design Management
Chongchuan District, Jiangsu, China · On-site
Senior+$2.0B raised
南通,中国 | 全职 | Job ID: 11661 About the role: As China SS&E Associate Director for project design management, you will play a key role in supporting China Head operation and oversees the design lifecycle of large-scale inve…
Director Medical Safety & Pharmacovigilence, Safety Strategy Lead
Changning District, Shanghai, China · On-site
Senior+$2.0B raised
Shanghai, China | full time | Job ID: 10561 Position Summary: The Safety Strategy Lead China represents a pivotal function in the BioNTech Safety Governance; therefore, the SSL assumes accountability for: an optimal perf…
Skills: Pharmacovigilance, Medical Safety Strategy, Benefit-Risk Assessment, Signal Management, Risk Management
Shanghai, China | full time | Job ID: 11516 Your contribution: Represent External QC Network at CMOs (predominantly located in China) ensuring QC and GMP requirements of BioNTech are considered Represent external/global …
Shanghai, China | full time | Job ID: 11516 Your contribution: Represent External QC Network at CMOs (predominantly located in China) ensuring QC and GMP requirements of BioNTech are considered Represent external/global …
Skills: External QC Network Management, GMP Compliance, Stability Program Oversight, CDMO Management, CMC Development
Director Program & Production Procurement CDMO / CMO
Munich, Bavaria, Germany · On-site
Senior+$2.0B raised
Mainz, Germany; Berlin, Germany; London, United Kingdom; Munich, Germany | full time | Job ID: 11585 About the Role: We are seeking a dynamic and experienced Director Program & Production Procurement CDMO / CMO to join o…
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$168k–$318k/yr
Full-time
postgraduate degree
Flexible hours, Vacation account, Digital learning, Performance and talent development, Leadership development, Apprenticeships
Posted 18h ago
Apply by Dec 31
~40 hrs/week
Responsibilities
The Senior Director will lead clinical trial design and execution from early exploratory studies through late-stage development and regulatory approval. They will also serve as a Program Lead to guide core teams, ensure patient safety, and manage medical aspects of clinical portfolios.
Requirements
Candidates must hold an M.D. degree with a robust scientific background in Immuno-Oncology or Oncology. Extensive experience leading clinical development programs across Phases I–III and interacting with global health authorities like the FDA and EMA is required.
Full job description
Munich, Germany; London, United Kingdom; Mainz, Germany | full time | Job ID: 11648
About the Role
As a (Senior) Director of Clinical Development at BioNTech, you will collaborate closely with the VP of Clinical Development to drive innovative strategies for assigned programs. In this pivotal role, you will oversee the design and execution of clinical trials across all phases, ensuring data integrity, patient safety, and regulatory approval. Leveraging your deep expertise in Immuno-Oncology and Oncology, you will lead matrix teams to deliver impactful results while guiding decisions with scientific rigor and medical insight. Join us to shape the future of medicine through cutting-edge research and development.
Your Contribution
Lead clinical trial design to develop plans for new compounds from early exploratory studies through late-stage development and regulatory approval.
Collaborate with the VP to operationalize clinical strategies for assigned portfolios and ensure alignment across functions.
Serve as Program Lead, guiding core teams, driving program strategy, and preparing submission processes.
Ensure patient safety by overseeing medical aspects of studies, conducting risk-benefit assessments, and addressing medical queries.
Innovate in trial design, leveraging digital endpoints and real-world evidence to enhance study outcomes.
Develop key clinical documents, including Investigator’s Brochures, NDAs, and high-quality Clinical Study Reports.
Build strong relationships with external stakeholders while representing the team in governance meetings.
A Good Match
M.D. degree with a robust scientific and clinical background in Immuno-Oncology or Oncology.
Extensive experience leading clinical development programs across Phases I–III, including NDA submissions.
Expertise in advanced clinical study designs, companion diagnostics for patient selection, translational modeling, biostatistics, and confirmatory Phase III trial design.
Proven experience interacting globally with health authorities (e.g., EMA, FDA), with successful registration being advantageous.
Strong medical acumen in monitoring safety/efficacy data and managing patient-centric drug development processes.
Exceptional leadership skills to mentor teams while accelerating capabilities through situational management styles. BioNTech offers a collaborative environment where innovation meets purpose. If you are passionate about advancing therapies that make a difference in patients' lives, we invite you to join our mission-driven team.
Expected Pay Range: $168,100-$318,300 plus 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.
Your Benefits:
It's our priority to support you:
Your flexibility: flexible hours | vacation account
Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
Your health and lifestyle: Company bike
Your mobility: Job ticket | Deutschlandticket
Your life phases: Employer-funded pension | Childcare
Apply now - We look forward to your application!
Apply to our Munich, Germany; London, United Kingdom; Mainz, Germanylocation by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 1 PM to 3 PM CET).
Job ID 11648 (please always specify if you have any questions)
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.
Our vision is to harness the power of the immune system to develop novel therapies against cancer & infectious diseases.
Industry
Biotechnology Research
Company size
1,001-5,000 employees
Founded
2008
Headquarters
Mainz, Rhineland-Palatinate
LinkedIn followers
300,524
Total funding
$2.0B
Biopharmaceutical New Technologies (BioNTech) is a global biotechnology company aspiring to translate science into survival by developing new immunotherapies utilizing the full potential of the immune system to fight cancer and infectious diseases.
BioNTech is headquartered in Mainz, Germany, and operates globally with almost 7.000 pioneers. Our work is powered by one mission: Improving the health of people worldwide. We believe that scientific rigor and passion are the driving forces that are essential for innovative progress.
BioNTech was founded in 2008 by scientists and physicians to translate science into survival by combining fundamental research and operational excellence. At BioNTech, we have been conducting fundamental research of mRNA technologies in the field of individualized cancer medicine for more than a decade. Some of our colleagues, including our co-founders, have been researching and developing mRNA-based vaccines for more than 25 years.
Ready to join us on this journey? Explore the opportunities and become part of a team that aspires to turn bold ideas into real-world solutions: https://www.biontech.com/int/en/home/careers.html
🔗 Privacy Statement: https://www.biontech.com/int/en/home/data-privacy-statement.html
🔗 Imprint: https://www.biontech.com/int/en/home/imprint.html
Offices: An der Goldgrube 12, Mainz, Rhineland-Palatinate 55131, DE · Vollmersbachstraße 66, Idar-Oberstein, Rhineland-Palatinate 55743, DE · Vollmerstr. 5, Berlin, Berlin 12489, DE · Am Klopferspitz 19a, Planegg, Bavaria 82152, DE · Forstenrieder Str. 8-14, Neuried, Bavaria 82061, DE
BiotechnologyIndividualized cancer medicinePatient-specific immunotherapymRNA therapeuticsCell therapyAntibody therapeuticsSmall molecule immunomodulatorsTailored therapeuticsImmunotherapyOncology
Our vision is to harness the power of the immune system to develop novel therapies against cancer & infectious diseases.
Industry
Biotechnology Research
Company size
1,001-5,000 employees
Founded
2008
Headquarters
Mainz, Rhineland-Palatinate
LinkedIn followers
300,524
Total funding
$2.0B
Biopharmaceutical New Technologies (BioNTech) is a global biotechnology company aspiring to translate science into survival by developing new immunotherapies utilizing the full potential of the immune system to fight cancer and infectious diseases.
BioNTech is headquartered in Mainz, Germany, and operates globally with almost 7.000 pioneers. Our work is powered by one mission: Improving the health of people worldwide. We believe that scientific rigor and passion are the driving forces that are essential for innovative progress.
BioNTech was founded in 2008 by scientists and physicians to translate science into survival by combining fundamental research and operational excellence. At BioNTech, we have been conducting fundamental research of mRNA technologies in the field of individualized cancer medicine for more than a decade. Some of our colleagues, including our co-founders, have been researching and developing mRNA-based vaccines for more than 25 years.
Ready to join us on this journey? Explore the opportunities and become part of a team that aspires to turn bold ideas into real-world solutions: https://www.biontech.com/int/en/home/careers.html
🔗 Privacy Statement: https://www.biontech.com/int/en/home/data-privacy-statement.html
🔗 Imprint: https://www.biontech.com/int/en/home/imprint.html
Offices: An der Goldgrube 12, Mainz, Rhineland-Palatinate 55131, DE · Vollmersbachstraße 66, Idar-Oberstein, Rhineland-Palatinate 55743, DE · Vollmerstr. 5, Berlin, Berlin 12489, DE · Am Klopferspitz 19a, Planegg, Bavaria 82152, DE · Forstenrieder Str. 8-14, Neuried, Bavaria 82061, DE
BiotechnologyIndividualized cancer medicinePatient-specific immunotherapymRNA therapeuticsCell therapyAntibody therapeuticsSmall molecule immunomodulatorsTailored therapeuticsImmunotherapyOncology