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Support the implementation of scientifically robust non-clinical safety strategies, spanning from NTC discovery through clinical trial execution to regulatory submission for marketing authorization, specifically for the development of intravitreal (IVT) medications in eye health across various modalities, ensuring alignment with external requirements and benchmark project strategies. Your role includes advising on all aspects of nonclinical safety for new drugs of different Modalities—covering the nonclinical testing strategy, study design, dose selection, and the overall toxicological assessments—and supporting the preparation of development plans, protocols, reports, and regulatory documents.

YEAR

Description 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 an opportunity for all employees to collaborate internationally, offering visibility and the opportunity to directly contribute to the company's 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, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Boehringer Ingelheim is currently seeking a Senior Research Fellow to support our Mental Health / Eye Health and Emerging Areas team to join our Ridgefield, CT facility. As the Senior Research Fellow of Mental Health/Eye Health and Emerging Areas, you will represent Nonclinical Safety in Boehringer project teams from discovery to submission. Your role includes advising on all aspects of nonclinical safety for new drugs of different Modalities—covering the nonclinical testing strategy, study design, dose selection, and the overall toxicological assessments—and supporting the preparation of development plans, protocols, reports, and regulatory documents. Duties & Responsibilities + Provides scientific input to create, organize, and implement local Research & Development programs and serves as a safety science lead within the department of Clinical Pharmacology and Non-Clinical Safety Sciences (CPS) for Mental Health, Eye Health, and Emerging Areas (MH, EH & EA). + Provides scientific guidance and contributions that progress research programs to major milestones. Support the implementation of scientifically robust non-clinical safety strategies, spanning from NTC discovery through clinical trial execution to regulatory submission for marketing authorization, specifically for the development of intravitreal (IVT) medications in eye health across various modalities, ensuring alignment with external requirements and benchmark project strategies. + Plan and execute non-clinical safety studies at appropriate stages to support asset progression through development; pro-actively manage safety liabilities + Be an active voice at local and international review meetings. + Plan, conduct, and oversee nonclinical safety development programs for multiple assets in parallel, focusing on new entities in Eye Health and/or Mental Health and Neurology. + Establishes 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. + Publishes regularly on specific and general topics in drug discovery or development. + Provides expert internal scientific review requested by Senior Management on issues of the R&D portfolio, technology investments and licensing opportunities. + Collaborates and works across/within teams to achieve Research & Development goals. + Develops role as key scientific mentor and teacher; Contribute to departmental recruiting efforts. + Independently consolidate safety findings into risk assessments, regulatory documents, including briefing books, investigational new drug applications (INDs), Investigator brochures (IBs), New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs) + Maintain an up-to-date understanding of FDA, EMA, ICH, and other relevant regulatory guidance; ensure incorporation of evolving scientific standards into development programs + Consults with local and global scientific leaders regarding strategic drug discovery and development issues. Delivers updates to Project Teams and Senior level management with context of overall project goals and impact on asset strategy + Generate concise safety assessments to support internal decision-making and prepare regulatory submission documentation, facilitating health authority reviews and approval processes throughout all phases of pre-clinical and clinical drug development. + Acts as the company toxicology representative and addresses questions in interactions with FDA, EMA and other authorities on preclinical safety topics + Understands current national and international regulations and legal requirements as well as BI policies and procedures as relevant to areas of expertise; Applies knowledge to ensure safe and compliant practices, manage risk, and maximize opportunities for projects to succeed. Compensation Data The base salary range for this position is $170,000.00 to $269,000.00 USD. The position may be eligible for a role specific discretionary bonus, relocation, and/or other compensation elements. We continuously review market data and may adjust salary ranges as needed in the future. Actual compensation will be based on job-related factors such as skills, experience, and qualifications, and other factors permitted by law. For an overview of our benefits please click here. (https://www.boehringer-ingelheim.com/us/careers/explore-our-company/benefits-rewards) Requirements + Ph.D. or equivalent, outstanding publications/patent/record (principal author) to obtain and extensive education and experience in pharmaceutical R&D with at least eight to ten (8-10) years’ experience in independent research. + Several years of experience in regulatory nonclinical drug safety (toxicology) for human pharmaceuticals in the sector for Eye Health and/or Mental Health with a proven track record in preparing regulatory documents (e.g. IB, IND, DSUR, CTD) and interacting with global health authorities. + Disease-area knowledge in at least one Therapeutic area (Eye health and/or Mental health + neuroscience) incl scientific understanding of preclinical models, clinical pathophysiology and therapeutic modalities approved or in development. + Ability to handle complexity in drug development and the management of interfaces + Demonstrated ability to recruit, mentor, motivate, teach, organize, and lead a scientific/technical staff. + Ability to harmonize global projects. + Demonstrated ability to work on international project teams to come to resolution on a project. + Offer Scientific insight to projects. + Exceptional knowledge of scientific area of responsibility; ability to ask critical scientific questions and to critique devised hypotheses, experiments, and results interpretation. + Demonstrated creativity and novel approaches to solving scientific problems. + Troubleshooting of key issues in successful technology transfers to other OPUs. + Excellent interpersonal skills with the ability to interact effectively with people, internally and externally at all levels of the organization. + Excellent communication, presentation, organizational and time-management skills, paired with intercultural experience and problem-solving abilities and initiative required + Must have exceptional oral and written presentation skills. + Onsite/Flex* : This position is site based with flexibility for remote working. Working onsite a minimum of 2-3 days per week is required. Remote working norms will be clarified during the interview process. 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. Desired Skills, Experience and Abilities DVM, MD or PhD with specialization or strong working experience in toxicology; board certified and experienced toxicologist for preparing regulatory documents. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

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Senior Research Fellow - Project Toxicologist, Mental Health / Eye Health Boehringer Ingelheim

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