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Nonclinical Safety Lead (all genders)

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Bayer

14d ago

  • Job
    Full-time
    Expert Level
  • Research & Development
    Healthcare
  • Berlin

AI generated summary

  • You need a Ph.D. in life sciences, extensive pharma experience in Toxicology/Safety Pharmacology, proven leadership, strong analytical skills, collaboration, networking abilities, and fluent English.
  • You will design nonclinical safety programs, analyze study findings, collaborate with teams, interact with Health Authorities, and stay updated on scientific advancements while ensuring compliance.

Requirements

  • 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

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

FAQs

What is the primary responsibility of the Nonclinical Safety Lead at Bayer?

The primary responsibility of the Nonclinical Safety Lead is to act as a subject matter expert in cross-functional project teams, overseeing all aspects of nonclinical safety assessment for new drug candidates from target identification to market authorization submission.

What qualifications are required for the Nonclinical Safety Lead position?

A university degree in natural sciences, medicine, veterinary medicine, pharmacy, or related fields, complemented by a Ph.D., is required for this position.

What kind of experience is necessary for this role?

Extensive relevant experience in the pharmaceutical industry, with a focus on Toxicology and/or Safety Pharmacology, and a broad understanding of global drug discovery and development is necessary.

Will I be part of international teams in this role?

Yes, you will demonstrate matrix leadership in international, multidisciplinary drug development teams.

Is fluency in any specific language required for this position?

Yes, fluency in English, both written and spoken, is required.

Does Bayer provide opportunities for professional development?

Yes, Bayer supports professional growth by providing access to learning and development opportunities, training programs, development dialogues, coaching, and mentoring.

Are there any family support benefits offered?

Yes, Bayer offers a variety of family support benefits, including company daycare centers, assistance in finding childcare, and time off for caring for elderly or dependent family members.

What is Bayer's stance on diversity and inclusion?

Bayer is committed to promoting diversity and providing an inclusive work environment where all individuals are welcomed, supported, and encouraged to bring their whole selves to work.

Where is the Nonclinical Safety Lead position located?

The position is located in Germany, with specific options in Berlin and North Rhine Westfalia (Wuppertal-Aprath).

Is there an annual bonus included in the compensation package?

Yes, the compensation package consists of an attractive base pay along with an annual bonus.

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Bayer

Science for a better life

Science & Healthcare
Industry
10,001+
Employees
1863
Founded Year

Mission & Purpose

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Our products and services are designed to benefit people and improve their quality of life. At the same time, we aim to create value through innovation, growth and high earning power. Our products help address some of today’s biggest challenges, including global population growth, an aging society and the need to make efficient – and, wherever possible, sustainable – use of natural resources. In line with our mission “Bayer: Science For A Better Life,” we aim to improve people’s quality of life by preventing, alleviating or curing diseases. We also help provide an adequate supply of high-quality food, feed and renewable plant-based raw materials. For these endeavors, we focus on developing and successfully commercializing innovative products and solutions based on scientific knowledge.