Description

The Vice President of Nonclinical Safety (NCS) leads a large, diverse team responsible the nonclinical safety assessment of US marketed drugs and compounds in Development (inclusive of genetox, safety pharm, in-life studies and pathology). This includes signing authority for the nonclinical safety assessment within all regulatory documents (including IND, CTX, CTA, NDA, etc.). The incumbent will provide strategic direction with respect to early safety assessments (for compounds still in a Research phase), exploratory study designs, digital pathology, molecular pathways, histology, AI for tox predictions, and innovation in execution.

The VP will provide strategic direction with respect to early safety assessments (for compounds still in a Research phase), exploratory study designs, digital pathology, molecular pathways, histology, AI for tox predictions, and innovation in execution. We are seeking proven industry leader with diverse modality and therapeutic experience and passion for excellence in execution, flexibility, and scientific depth.

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 several 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

Ensures all nonclinical safety studies are conducted in support of all compounds in Development and balanced between in-house and CRO activities
Provides diligent safety assessments and risk/benefits analyses of compounds in Development for decision making purposes.
Provides optimal support for all branded pharmaceuticals as necessary.
Provide nonclinical safety work pages for all NCEs/EBEs in accordance with state of the art regulatory requirements.
Technical visionary leadership (strategy and implementation): to provide the technical direction and the establish the level of competency within the department
Organizational visionary leadership (strategy and implementation) to utilize the available talent within the department and plan for future growth
Provide subordinate career development to ensure the future success within the department
Strong collaboration with understanding of critical Quality attributes, setting specifications, and closely interacting with CMC, Translational Medicine, and Clinical Development
Participates as a member of internal nonclinical safety committee meetings and represents the company on external nonclinical safety committees as necessary
Ensures compliance with all required training, safety, regulatory, HR, laboratory notebook and intellectual property activities and corporate policies
Recruits, retains and develops high quality staff

Requirements

Ph.D. Degree, D.V.M. or equivalent in Toxicology, Biology or similar Medical Sciences
Twelve plus (12+) years of Toxicology study design and strategy in intermediate to large PHARMA
Technical training in the discipline of Toxicology and demonstrated knowledge in the area (submissions, publications, presentations)
Expertise with Biologicals, viruses or non-classical IgGs as ADCs preferred
Experience with diverse Disease indications (eg Oncology, Inflammatory Diseases, Cardio-metabolic Disease) is ideal
Experienced in international regulatory requirements
Leadership skills in developing/coaching talents, developing strategies and organizations including global collaboration are essential.
Strength in collaborating with diverse interdisciplinary and/international teams and ability to navigate a complex global matrix
Ability to build good relationships in the scientific community
Demonstrated vision with strength in giving direction, prioritization, and developing modern/innovative concepts
Ability to make decisions, to live with ambiguity, and accept accountabilities is key.
Line management and budgetary experience

Compensation Data

Compensation:This position offers a base salary typically between $280,000 and $441,000. 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.