Director, Nonclinical Safety & Portfolio Strategy

BioSpace; North Chicago (IL); Sur place; USD 150 000 - 200 000; Plein temps

Avantages offerts par ce poste

Comprehensive benefits package

Paid time off

401(k) options

Résumé du poste

BioSpace is looking for a Senior Director to lead the nonclinical safety representative role, collaborating across AbbVie's diverse portfolio. This position requires 15+ years of experience in the pharmaceutical industry and authoring regulatory documents.

The ideal candidate will drive strategic vision in nonclinical safety and mentor others in drug development. A comprehensive benefits package is offered, along with eligibility for short-term incentive programs.

Qualifications

• 15+ years of experience in the pharmaceutical industry leading nonclinical safety programs.
• Experience authoring relevant regulatory documents and responding to requests from regulatory agencies.
• Skilled in project/program management and leadership.

Responsabilités

• Drive the strategic vision for nonclinical safety.
• Serve as an active member for multi-disciplinary project teams.
• Participate in due diligence reviews of drug products to identify potential risks.
• Lead, mentor and develop others in drug development.

Connaissances

Nonclinical safety expertise

Project management

Regulatory document authoring

Deep therapeutic area knowledge

Formation

PhD or DVM

Outils

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Description du poste

Overview

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people\'s lives across several key therapeutic areas including immunology, oncology and neuroscience – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Description

AbbVies Development Biological Sciences department is seeking a Senior Director for its Portfolio Leadership Group. This pivotal leadership role will serve as a nonclinical safety representative for assigned molecules across AbbVies diverse portfolio. As a safety representative, the Senior Director will be responsible for the overall strategy and execution of the nonclinical toxicology program, collaborating cross-functionally with project leads, providing data interpretation at various internal and external venues, and authoring regulatory documents.

The ideal candidate will have 15+ years of experience in the area of non-clinical safety within the pharmaceutical industry. He/she should have the experience and ability to develop drug candidates from discovery through marketing. This senior-level position is expected to have a high impact contributing scientific expertise in nonclinical safety assessment, knowledge of industry best practices and pertinent regulatory guidelines, and a vision of future enhancements in the field.

Responsibilities

• Drive the strategic vision and direction for nonclinical safety, influencing key R&D and portfolio decisions at the organizational level.
• Serve as an active member for multi-disciplinary project teams as a nonclinical safety functional area subject matter expert.
• Articulate and communicate non-clinical safety strategies and provide development plans for multiple drug modalities including but not limited to small molecules, biologics, ADCs, and/or cell and gene therapies, across various therapeutic areas including but not limited to oncology, neuroscience, and immunology.
• Participate in due diligence reviews of drug products to identify potential risks and provide recommendations for partnership or in-licensing.
• Author and submit regulatory documents (IBs, INDs/CTAs, NDAs/BLAs, regulatory queries) and interact with regulatory agencies (US and ex-US) as needed.
• Generate impurity, excipient and metabolite risk assessments as necessary during the life cycle of a drug candidate.
• Lead, mentor and develop others as it pertains to drug development and the execution of the portfolio, with an emphasis on the nonclinical aspects.
• Participation in pharmaceutical industry consortia related to nonclinical aspects of drug development.

Qualifications

• PhD or DVM required.
• 15+ years of relevant experience in pharmaceutical industry leading nonclinical safety programs.
• Experience authoring relevant regulatory documents and responding to requests from regulatory agencies.
• Deep expertise in a particular therapeutic area or modality (e.g. immunology, gene therapy, etc) is a benefit, but not required.
• General awareness and understanding of drug metabolism and pharmacokinetics and its interplay with safety (e.g. MIST, drug-drug interactions, toxicokinetics, anti-drug antibodies...) is a plus.
• Skilled in project/program management and leadership.
• General computer skills and knowledge of the Microsoft applications including but not limited to Microsoft Word, Excel, and PowerPoint and applying AI as appropriate and necessary.

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company\'s sole and absolute discretion unless and until paid and may be modified at the Company\'s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html