Berkeley Heights Director, Quantitative Clinical Pharmacology NJ NJ 07922

Job description

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 modeli n g activities u sing 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. 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! 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