Description

As a primary responsibility, this job has oversight for the design and execution of nonclinical safety programs to support the development of drug candidates from discovery to market authorization. The incumbent will be highly motivated and independently manage a portfolio of projects in multiple therapeutic areas and modalities including small molecules, monoclonal antibody-based biotherapeutics, viral, and gene therapies.

As the primary interface between global project teams and Nonclinical Drug Safety, the incumbent is responsible for developing nonclinical safety strategies that support the clinical development plan in oncology and non-oncology indications. The NDS team member will be the primary interface with global health authorities and will consolidate safety data from nonclinical studies into regulatory submissions as needed. In addition, integrated safety assessments may also be presented to senior management at milestone review meetings. The incumbent may also serve as, or interface closely with, Therapeutic Area Leads responsible for knowledge of a broad therapeutic area and related internal portfolio.

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

• Serve as NDS Representative (Team Member Toxicology) on multiple interdisciplinary Project Teams from Start of Development to Loss of Exclusivity.
• Plan and execute non-clinical safety studies and pre-clinical safety assessments at appropriate stages to support asset progression through development; pro-actively manage safety liabilities.
• Deliver updates to Project Teams and Senior Level management with context of overall project goals and impact on asset strategy.
• Independently consolidate safety findings into regulatory documents, including briefing books, investigational new drug applications (INDs), Investigator brochures (IBs), New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs).
• Acts as the company toxicology representative and addresses questions in interactions with FDA, EMA and other authorities on preclinical safety topics.
• Works closely with Research Pharmacology, Drug Metabolism & Pharmacokinetics, Translational Medicine & Clinical Pharmacology, CMC, Regulatory Affairs, Patient Safety and Pharmacovigilance to implement discovery and development toxicology strategies that enable the progression of optimized drug candidates.
• When appropriate, take lead to develop plan and lead sub-team for investigative studies to support investigations on mechanisms of toxicity.
• Serve as NDS Therapeutic Area lead, and/or provide guidance and subject matter expertise (SME) in NDS relevant area of expertise, and/or serve as company representative on external pre-clinical safety related consortia.
• Contributes to departmental administration; Demonstrates fiscal responsibility with respect to cost of experiments, technology, external collaborations, and travel.

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. Experience with NDA, BLA, MAA submissions advantageous.
• Knowledge of specific platforms (e.g. viral and gene therapies, monoclonal antibodies, ADCs) 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.

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.

Compensation: This position offers a base salary typically between $135,000 and $232,000. There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. The position may be eligible for a role specific variable or performance-based bonus and/or other compensation elements. For an overview of our benefits please click here.

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