Pharmacometrics Expert / Modeling & Simulation Expert (all genders)

Bayer; Berlin; Hybrid; EUR 80.000 - 100.000; Vollzeit

Zusammenfassung

A global life sciences company in Berlin seeks a Pharmacometric Expert to shape Model Informed Drug Development. You'll lead and advise on complex PMX projects, ensuring regulatory compliance and improving methodologies across therapeutic areas. The ideal candidate has a PhD in Life Sciences, leadership experience, and expertise in pharmacometrics tools. This role offers a competitive package and a flexible working model.

Leistungen

Competitive compensation package

Flexible work arrangements

Family support services

Learning and development opportunities

Health and well-being initiatives

Qualifikationen

• University degree and PhD in related field.
• Years of experience in pharmaceutical sector.
• Fluency in English, German is an advantage.

Aufgaben

• Develop strategies for MIDD implementation in drug development.
• Conduct or organize PMX analysis across therapeutic areas.
• Provide regulatory knowledge for drug development compliance.

Kenntnisse

Population PK/PD methodology expertise

Leadership skills

Regulatory knowledge

Expert-level knowledge in NONMEM

Fluency in English

Ausbildung

PhD in Life Sciences, Engineering, or Mathematics

Tools

NONMEM

Monolix

R (RxODE, nlmixR)

Jobbeschreibung

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Pharmacometrics Expert / Modeling & Simulation Expert (all genders)

YOUR TASKS AND RESPONSIBILITIES

Would you like to help shape Model Informed Drug Development (MIDD) at Bayer? Then become part of Pharmacometrics (PMX) as a Pharmacometric expert / Modeling & Simulation Expert (m / f / d).

• You will work together with the MIDD Lead to develop strategies for the implementation of MIDD in drug development, you are particularly responsible for the strategic planning of PMX project contributions to address development-related project questions, thereby enabling MIDD
• You are responsible for conducting or organizing PMX analysis (in particular Population PK, Population PK / PD, Exposure-Response and Model Based Meta Analysis (MBMA)) in all therapeutic areas from early development to market for assigned projects
• You supervise outsourced PMX projects to assure the best possible project impact
• You lead PMX project teams and provide scientific advice to other PMX experts on site, support as an experienced coach to coordinate and prioritize respective activities
• You provide PMX specific regulatory knowledge in either early or late stages of drug development (FIM, EOP-II, submission) and ensure compliance with regulations and guidance’s of regulatory authorities
• You review PMX model results by using and demonstrating in depth clinical, pharmaceutical, and biological knowledge
• You solve methodological / mathematical challenges in complex modeling projects
• You develop and implement new PMX methodologies to further improve project support in all therapeutic areas

WHO YOU ARE

• You have a university degree and PhD in (Life) Sciences (Pharmacy / Medicine), Engineering, and / or Mathematics with a specialization in population PK / PD M&S and / or Statistics
• Your career includes several years of experience within the pharmaceutical sector, showcasing profound, hands‑on expertise in population PK / PD M&S methodologies, an academic track record, potentially including a post‑doctoral position with a focus on Pharmacometrics and a notable publication history, would be beneficial
• You can demonstrate expert‑level knowledge in NONMEM, Monolix, R (RxODE, nlmixR) and other relevant pharmacometrics tools
• You possess a solid understanding of pharmacology and pharmacokinetics, with in‑depth knowledge in either cardiovascular or oncology indications
• Your mathematical skills are excellent
• You have comprehensive knowledge of regulatory requirements in either early or late‑stage drug development (FIM, EOP-II, submission) and experience in regulatory interactions and submission processes
• Your experience encompasses leading small pharmacometrics (PMX) teams and overseeing outsourced PMX projects, demonstrating leadership and project management skills
• You are fluent in English, both verbal and written (German is an advantage)

WHAT WE OFFER

Our benefits package is flexible, appreciative, and tailored to your lifestyle, because : What matters to you, matters to us!

• We ensure your financial stability through a competitive compensation package, consisting of an attractive base pay and our annual bonus. In addition, managers can recognize special contributions by granting an individual performance award
• Whether it’s hybrid work models or part‑time arrangements : Whenever it is possible, you will have the flexibility to work how, when and where it is best for you
• Your family is a top priority. We offer loving company daycare centers at multiple locations, support in finding childcare, time off for the care of elderly or dependent family members, summer camps for children, and much more
• We support your professional growth by providing access to learning and development opportunities, training programs through the Bayer Learning Academy, development dialogues, as well as coaching and mentoring programs
• We support your health and well‑being with free check‑ups by our company doctor, health seminars, and a wide range of initiatives that promote a healthy lifestyle
• We embrace diversity by providing an inclusive work environment in which you are welcomed, supported, and encouraged to bring your whole self to work

Be You. Be Bayer.