Director Development Sciences Licensing Acquisitions
Director Development Sciences Licensing Acquisitions
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Salary Not Disclosed
1 Vacancy
Job Description
Purpose:
This position is responsible for representing Development Sciences Chemistry Manufacturing & Controls (CMC) space to Corporate Licensing and Acquisitions (L&A) in the evaluation and assessment of potential external pipeline acquisition or licensing opportunities across various drug/combination product asset types and therapeutic areas. Partner with Clinical Regulatory Operations Quality Biological Sciences Finance and Commercial Organizations during all phases of external diligence process including technical assessment development/resource planning negotiations deal and transition to internal teams.
Responsibilities:
- Lead CMC Due Diligence activities for Development Sciences including integration of the CMC strategy with the Clinical Development plan in support of Business Development opportunities.
- Responsible for critical technical scientific evaluation of CMC drug substance drug product and device development information during due diligence & evaluation process. This requires assessment and integration of drug substance process characterization of physical chemical properties formulation science engineering analytical and device technical information in conjunction with the project strategy with full consideration of current regulatory and compliance requirements.
- Responsible for identifying key CMC findings and potential risks for a given project. Prepare and present a balanced view of the Dev Sci CMC considerations in partnership with PDS&T and Operations including risks to senior Dev Sci leaders and within appropriate governance process forums for utilization in the broader decisionmaking process on external L&A opportunities.
- Apprise Development Sciences CMC Leadership of development strategies risk assessments and mitigation plans through regular communications and periodic reviews throughout diligence process and in support of potential deal .
- For executed deals coordinate with Development Sciences leadership to identify Product Development Director and drive the knowledge transfer process with the internal team and Dev Sci integration lead in support of a successful program transition to enable achievement of the expected business & financial outcomes.
- Establish an appropriate Dev Sci development/resource plan required for successful transition and/or integration including assessing potential 3rd party suppliers of acquired assets ensuring business continuity of clinical/commercial supply.
- Responsible for managing multiple CMC diligence projects within or across multiple therapeutic areas (TAs) in a highvolume and fastpaced environment and effectively delivering diligence project objectives.
- Stay abreast of developments in global CMC technical regulatory and compliance arena and industry practice ensuring assessments are measured and reflective of the current external landscape
Qualifications :
*This position will be required to sit onsite 3 days / week*
Qualifications:
- Bachelors Degree with at least 12 years of relevant CMC experience; or Masters degree with at least 10 years of relevant CMC experience; or PhD with at least 4 years of relevant CMC experience.
- Advanced knowledge and demonstrated skills in a CMC functional discipline and diverse interdisciplinary scientific knowledge and experience for various asset types (e.g. small molecules biologics peptides) in different therapeutic areas.
- Ability to leverage product development experience in pharmaceutical/combination product development quality regulatory/compliance requirements budget and resource planning across all phases of CMC drug development for objective evaluation of development status for potential external opportunities. Be comfortable leading in an ambiguous environment. Apply scientific understanding and sound judgment to get aligned decisions.
- Demonstrated experience in providing functional or team leadership to drive multiple complex projects to deliver timely highquality results in a cross functional team environment through IND and NDA(BLA)/MAA preferred. Ability to assess if story lines and data packages for regulatory submissions accurately represent and clearly summarize the development history and are consistent with the overall regulatory strategy for the asset to enable global filings.
- Possess negotiating influencing project management and leadership skills to represent CMC on multifunctional diligence teams to evaluate target opportunities and produce high quality assessments. Expert communicator in a transparent and courageous manner to all stakeholders to influence diligence strategies. Present individual and team recommendations clearly and concisely and promote crossfunctional communication to achieve alignment with senior management internal and external partners and governance bodies. Senior executive management presentation experience strongly preferred.
- Possess the technical and scientific understanding to generate a comprehensive CMC development strategy balancing technical and operational risks and tradeoffs of different options to translate a clinical development plan into a phase appropriate CMC product development strategy and executable plans.
Key Stakeholders: VP Development Sciences Development Sciences CMC Functional Heads S&E and BD groups; PDS&T Operations R&D Finance
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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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No
Employment Type :
Fulltime
Employment Type
Full-time
