Director, Development Sciences Licensing & Acquisitions
Company: Allergan
Location: Lincoln
Posted on: April 1, 2025
Job Description:
Company DescriptionAbbVie'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,,,,and.Job DescriptionPurpose: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
execution, 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 decision-making 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 execution.
- 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 high-volume and
fast-paced 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
on-site 3 days / week*Qualifications:
- Bachelor's Degree with at least 12 years of relevant CMC
experience; or Master's 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
high-quality 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 cross-functional 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 trade-offs 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
FinanceAdditional InformationApplicable 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.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, serving our community and embracing diversity
and inclusion. It is AbbVie's 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.US &
Puerto Rico only - to learn more, visitUS & Puerto Rico applicants
seeking a reasonable accommodation, click here to learn more:
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Keywords: Allergan, Lincoln , Director, Development Sciences Licensing & Acquisitions, Executive , Lincoln, Nebraska
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