BioNTech SE

Director, Quantitative Clinical Pharmacology

BioNTech SE  •  $168k/yr  •  Berkeley Heights, NJ (Onsite)  •  3 hours ago
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Job Description

Cambridge, US; Gaithersburg, US; New Jersey, US | full time | Job ID: 11769

About the Role:

As the Director of Quantitative Clinical Pharmacology, you will play a pivotal role in advancing BioNTech’s innovative drug development pipeline. Your expertise in population pharmacokinetics (PK), exposure-response (ER), and pharmacokinetic/pharmacodynamic (PK/PD) modeling will directly contribute to the development of new treatments for patients worldwide. In this position, you will lead program-level pharmacometrics strategies, foster cross-functional collaboration to drive decision-making, and support regulatory submissions such as IND and NDA/BLA filings. You will also serve as a mentor within the department while shaping best practices in quantitative modeling and analysis.

Your Contribution:

  • Lead hands-on and supervisory population PK, ER, and PK/PD modeling activities using software such as NONMEM, R, Phoenix WinNonlin, or MATLAB
  • Drive translational modeling to connect preclinical data with clinical outcomes, supporting dose optimization and go/no-go decisions
  • Provide strategic oversight and leadership of external pharmacometrics vendor partnerships, including scope definition, study oversight, quality review, budget management, and delivery of modeling and simulation activities
  • Provide quantitative insights for regulatory documents and serve as BioNTech’s representative during Health Authority engagements worldwide
  • Influence program strategy through pharmacometric leadership across cross-functional teams
  • Recruit, mentor, and develop junior staff while contributing to departmental best practices

A Good Match:

  • Ph.D., Pharm.D., or M.D. in pharmaceutics, pharmacokinetics, or related fields; M.S. with extensive relevant experience also considered
  • Minimum 8 years in biotechnology or pharmaceuticals with hands-on expertise in population PK/PD modeling and regulatory submissions
  • Proficiency in NONMEM, R, Phoenix WinNonlin, MATLAB; strong documentation skills for delivering high-quality analyses independently
  • Experience overseeing, or other applicable experience with external pharmacometrics vendors and managing modeling and simulation deliverables across multiple programs
  • Proven ability to lead matrixed teams effectively; excellent communication skills for conveying complex concepts at all levels
  • Experience in oncology; deep understanding of translational research principles

Your benefits and remuneration:

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.

BioNTech SE

About BioNTech SE

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

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Industry
Biotech & Life Sciences
Company Size
5,001-10,000 employees
Headquarters
Mainz, DE
Year Founded
2008
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