Biotherapeutic Project Toxicologist - Senior Principal Scientist/Senior Research Fellow
US-BI Pharma/BI USA
 Ridgefield, CT

Description:

The basic purpose of this position is to champion the nonclinical drug safety development of compounds within the portfolio. This is accomplished through providing state of the art strategy, high quality scientific guidance, creativity in study design and the promotion of internal and external regulatory requirements necessary for decision making and the safe advancement of projects. Manage complex projects and act as an internal consultant to programs involving areas of expertise.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities:

  • Provide scientific guidance and contributions that progress R&D programs to major milestones; Develop and champion innovative nonclinical drug safety strategies that support clinical research. Scientific approaches are expected to reflect a mature scientific understanding of the total drug discovery and development process; It is expected that the incumbent will have established a track record of positive contributions to the development of small molecule and biotherapeutic drug portfolios.
  • Prepare high quality regulatory submission documents in support of global clinical development.
  • Provide expert internal scientific review requested by Senior Management on issues of the R&D portfolio, technology investments and licensing opportunities. Represent Boehringer Ingelheim at consultions with international regulatory authorities.
  • Champions and implements innovative techniques/ideas/concepts to support the advancement of the BI product portfolio.
  • Be an active voice at local and international review meetings; Establish an international reputation in area of expertise; Represent BI as a scientific leader in field of expertise at both internal and national/international conferences, meetings and organizations; Publish on specific and general topics in nonclinical drug safety in discovery or development.
  • Through knowledge gained from participation in external industry working groups/professional societies or equivalent, bring knowledge of external best practices to bear on local projects.
  • Influence the professional development of colleagues as a scientific mentor and teacher; contribute/facilitate departmental recruiting efforts.
  • Consult with local and global scientific leaders regarding strategic drug discovery and development issues.
  • Understands current national and international regulations and legal requirements. Complies with applicable regulations; Ensure that all work performed in area of responsibility is conducted in a safe and compliant manner; Maintain proper records in accordance with SOP’s and policies.

The candidate will be hired at the level commensurate with their experience and education

Sr. Principal Scientist Requirements:

  • PhD or equivalent degree from an accredited institution in the areas Toxicology or Pharmacology with 7 years related experience.
  • DABT certification is desirable.
  • Demonstrates a broad knowledge in field of toxicology. Candidate possesses practical knowledge of pharmaceutical toxicology including approaches to discovery toxicology, relevant regulatory guidelines and preparation of submission documentation.
  • Knowledge of specific platforms (e.g. viral and gene therapies, monoclonal antibodies, and oligonucleotides) or therapeutic areas is highly desirable.
  • Routinely apply optimal tactical practices that impact projects, filings, and other disciplines.
  • Enable team to deliver milestones by defining research and development project goals; ensuring execution of the plan and that the team has sufficient resources.
  • Demonstrates ability to work effectively in a team environment.
  • Excellent ability to communicate effectively both orally and in writing in an interdisciplinary environment.

Sr. Research Fellow Requirements:

  • Ph.D. or equivalent degree from an accredited institution in the areas Toxicology or Pharmacology, with ten (10) or more years relevant experience.
  • DABT certification is desirable.
  • Demonstrates a broad knowledge in field of toxicology. Candidate possesses practical knowledge of pharmaceutical toxicology including approaches to discovery toxicology, relevant regulatory guidelines and preparation of submission documentation.
  • Knowledge of specific platforms (e.g. viral and gene therapies, monoclonal antibodies, and oligonucleotides) or therapeutic areas is highly desirable.
  • Effectively identify multi-disciplinary solutions to problems that impact projects, filings, and business processes.
  • Contributes to R&D portfolio by providing scientific guidance to project teams and leveraging understanding of drug R&D process.
  • Creates and executes broad tactical and scientific change plans at department and function levels, ensuring it is resourced and stakeholders are on board.
  • Demonstrates ability to work effectively in a team environment.
  • Excellent ability to communicate effectively both orally and in writing in an interdisciplinary environment.

Eligibility Requirements:

  • Must be legally authorized to work in the United States without restriction.
  • Must be willing to take a drug test and post-offer physical (if required)
  • Must be 18 years of age or older

Who We Are:

At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA Inc., Boehringer Ingelheim Animal Health Puerto Rico LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; citizenship status, marital, domestic partnership or civil union status; gender, gender identity or expression; affectional or sexual orientation; pregnancy, childbirth or related medical condition; physical or psychiatric disability; veteran or military status; domestic violence victim status; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by applicable federal, state or local law.

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