Scientific Director Sr Director Toxicology Development Biological Sciences nonclinical
Scientific Director Sr Director Toxicology Development Biological Sciences nonclinical
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Job Description
AbbVies Development Biological Sciences department is seeking a Scientific Director for its Portfolio Leadership Group. The primary function of this role will be to serve as a nonclinical safety representative for assigned molecules across AbbVies diverse portfolio. As a safety representative the Scientific Director will be responsible for the overall strategy and execution of the nonclinical toxicology program collaborating crossfunctionally with project leads providing data interpretation at various internal and external venues and authoring regulatory documents.
The ideal candidate will have 10 years of experience in the area of nonclinical safety within the pharmaceutical industry. He/she should have the experience and ability to develop drug candidates from discovery through marketing. This seniorlevel 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.
This position is located at our headquarters in Lake County IL just north of Chicago and will be expected onsite minimally 3 days a week.
Essential Responsibilities:
- Serve as an active member for multidisciplinary project teams as a nonclinical safety functional area subject matter expert.
- Articulate and communicate nonclinical 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 inlicensing.
- Author and submit regulatory documents (IBs INDs/CTAs NDAs/BLAs regulatory queries) and interact with regulatory agencies (US and exUS) as needed.
- Generate impurity excipient and metabolite risk assessments as necessary during the life cycle of a drug candidate.
- Support and mentor 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 :
*This position can be hired at Scientific Director or Sr. Director level dependent upon years of relevant experience and education*
Qualifications for the Scientific Director level:
- PhD or DVM required
- 10 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. gene therapy) is a benefit but not required
- General awareness and understanding of drug metabolism and pharmacokinetics and its interplay with safety (e.g. MIST drugdrug interactions toxicokinetics antidrug 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
Qualifications for the Sr. Director level:
- Doctor of Veterinary Medicine (DVM) Doctor of Medicine (DM) or PhD in a relevant area preferably with a certification in the assigned therapeutic area.
- At least 8 years experience of major drug development experience gained within the pharmaceutical industry or at least 12 years experience in science or businessrelated field and demonstrated scientific expertise.
- A solid knowledge of all aspects of the complete pharmaceutical research and development process.
- Broad international experience specifically regarding drug development and associated compliance and filing requirements.
- Proven experience of managing a large group of scientists and technicians in multiple locations supporting global drug development projects.
Leadership Attributes:
- Ability to anticipate recognize and resolve scientific and technical problems that are encountered during various phases of drug development
- Strong communication and presentation skills
- Ability to work in collaboration with other functional areas and within a matrix organization.
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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 shortterm incentive programs.
- This job is eligible to participate in our longterm 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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 serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
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Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
