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.

Preclinical Development (PCD) Lead Nonclinical Safety (all genders)

As PCD Lead Nonclinical Safety (all genders) you will act as a subject matter expert in cross-functional project teams and have direct responsibility for all aspects of nonclinical safety assessment for new drug candidates across indications and modalities from target identification to submission for market authorization and beyond.

YOUR TASKS AND RESPONSIBILITIES

• Actively participate in interdisciplinary project teams as PCD representative, alignment on timelines and budgets
• Represent nonclinical safety in interactions with Health Authorities
• Offer expertise regarding safety profiles during early project stages to aid in candidate selection
• Design and manage customized nonclinical safety programs that assess the safety of new drug candidates, adhering to regulatory requirements, patient needs, and the latest scientific advancements
• Collaborate with internal and external experts to coordinate specific study details and engage in the evaluation of external opportunities and due diligence
• Analyze findings from nonclinical safety studies to evaluate potential human risks and propose mitigation strategies
• Foster peer discussions to align testing strategies and safety assessments throughout the preclinical development process
• Maintain proactive collaboration with key R&D functions to ensure the quality of drug substances/products, assist in clinical trial design, and author relevant nonclinical sections of regulatory documents (INDs, IMPDs, IBs, CTAs, NDAs/BLAs, and MAAs)
• Keep informed on the latest scientific and technological developments in nonclinical safety, applying this knowledge to current projects and participating in external meetings and conferences to demonstrate our expertise

WHO YOU ARE

• University degree in natural sciences, medicine, veterinary medicine, pharmacy, or related fields, complemented by a Ph.D.
• Extensive relevant experience in the pharmaceutical industry, with a broad understanding of global drug discovery and development, with a focus on Toxicology and/or Safety Pharmacology, preferably with experience in radiopharmaceutical development
• Demonstrated matrix leadership in international, multidisciplinary drug development teams
• Capable of analyzing complex, high-volume, and sometimes conflicting information to effectively manage projects and resolve problems
• Skilled in structuring and guiding complex processes while aligning with multiple stakeholders across various levels
• Models collaboration across functions and organizations, fostering open and trustworthy dialogue with stakeholders both within and outside the organization
• An excellent networker and team player, with proven ability to build relationships internally and externally
• Actively seeks and acts on feedback from diverse sources and pursues challenging assignments for personal and professional growth
• Fluent in English, both written and spoken

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 with a competitive salary plus a variable component and a global equity-based cash plan. Your compensation is based on your qualifications, skills, and professional experience.
• 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 promote health awareness and opportunities for selfcare through various measures, such as free health checks with the company doctor.
• 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.

#LI-AMSEMEA

YOUR APPLICATION

This is your opportunity to tackle the world’s biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change. You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer.

Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

Location: Germany : Berlin : Berlin

Division: Pharmaceuticals

Reference Code: 874369