Preclinical Development (PCD) Lead Nonclinical Safety (all genders)
Preclinical Development (PCD) Lead Nonclinical Safety (all genders)
- 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
WAS SIE MITBRINGEN
- 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
- 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
WHY BAYER?
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.
- 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 bestfor 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 ordependent 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 LearningAcademy, 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 and ourhealth platform #machtfit.
- We emb diversity by providing an inclusive work environment in which you are welcomed, supported, and encouraged to bring your whole self towork.
Ever feel burnt out by bureaucracy? Us too. That’s why we’re changing the way we work - for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here https://www.bayer.com/en/strategy/strategy
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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 national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, orientation, gender identity, gender expression or any criterion under applicable law. We are committed to treating all applicants fairly and avoiding Location: Germany : Berlin : Berlin || Germany : North Rhine Westfalia : Wuppertal-Aprath
Division: PharmaceuticalsReference Code: 835551
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