Director, Preclinical Safety

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .

Job Description

Purpose:

Serves as a safety pharmacology strategist for assets across AbbVie’s portfolio. Responsible for the overall strategy and execution of the safety pharmacology strategy, collaborating cross-functionally with project leads, communicating decision-enabling data interpretation at various internal and external venues including Senior Leadership at governance meetings, and authoring regulatory documents.

This senior-level position is expected to have a high impact contributing scientific expertise in safety pharmacology assessment, knowledge of industry best practices and pertinent regulatory guidelines, and a vision of future enhancements in the field. The candidate will also manage a group of internal safety pharmacologist and staff.

Responsibilities:

• Serve as an active member for multi-disciplinary project teams as a safety pharmacology functional area expert. Manages several programs of very high complexity. Influences project timelines to ensure proper completion of required activities.
• Articulate and communicate safety pharmacology strategies and provide development plans for multiple drug modalities including but not limited to small molecules, peptides, biologics, and ADCs, across various therapeutic areas including, but not limited to, oncology, neuroscience, and immunology.
• Contribute to due diligence reviews by conducting technical assessments of external assets 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.
• May participate in pharmaceutical industry consortia related to safety pharmacology and nonclinical safety aspects of drug development
• Represents AbbVie on high profile partnerships and collaborations with other pharma/biotech companies driving program decisions
• Ensures strategic alignment with other stakeholder functions to ensure key deliverables enabling asset/project advancement are met and risks and mitigation plans are in place.
• Mentor safety pharmacology and nonclinical safety peers and other less experienced team members leading in a matrix-based approach. Responsible for performance and career development of direct reports. Contributes to continuous skill/gap assessment and performance and impact improvement of safety pharmacology function and contributes to developing and executing strategies to advance functional performance.

Qualifications

• Bachelor’s Degree with at least 20 years of experience in a variety of relevant functions required; Master’s Degree with at least 18 years of relevant experience required; or PhD with at least 12 years of relevant experience required. At least 10 years of working experience required in the same/similar role or in related safety pharmacology function.
• Multiple experiences of leading projects through IND and NDA/BLA/MAA highly desired.
• Must possess excellent scientific writing and verbal communication skills.
• Strong experience designing, overseeing, and interpreting GLP and non-GLP safety pharmacology studies.
• Must have excellent working knowledge of regulatory requirements and familiarity with relevant safety pharmacology assays, and translational technologies.
• Excellent knowledge of pharmaceutical drug discovery and development processes, including working knowledge of partner functions.
• Must have in-depth safety pharmacology interdisciplinary experience and expertise.
• Evidence of prior supervisory or management experience.
• Possesses negotiating, influencing, leadership skills.
• Creative in implementing entrepreneurial thinking and making smart business decisions.
• Ensures high level of morale and collaboration in cross-functional teams to maximize team impact and output.

Leadership Attributes:

• Ability to anticipate, recognize and resolve scientific and technical problems that are encountered during various phases of drug discovery and development.
• Strong communication and presentation skills.
• Ability to work in collaboration with other functional areas, within a matrix organization and effectively manage interactions with senior leadership.
• Ability to develop and execute complex strategies.
• Strong sense of personal responsibility and integrity and strong commitment to quality.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• 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. ​

• This job is eligible to participate in our long-term incentive programs​

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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.

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