Janssen Pharmaceutical Companies of Johnson & Johnson is
currently recruiting for an Associate Director, Licensing & Acquisition that
can be based remotely anywhere in the US or onsite at any Johnson & Johnson
site in the US. The position will also require travel up to 25%.
At the Janssen Pharmaceutical Companies of Johnson & Johnson,
what matters most is helping people live full and healthy lives. We focus on
treating, curing and preventing some of the most devastating and complex
diseases of our time. And we pursue the most promising science, wherever it
might be found.
We are Janssen. Our mission drives us. Our patients inspire us. We
collaborate with the world for the health of everyone in it.
The Associate Director, Licensing & Acquisition will:
- Be a member of the Quality Planning & Strategy (QP&S)
Licensing & Acquisition (L&A) group in BioResearch Quality &
Compliance (BRQC) Janssen.
- Will lead and coordinate with key business partners the process
for quality review and input during due diligence, post-signing assessment and
integration activities for GxP aspects of cross-pharma L&A, mergers and
acquisition (M&A), and out licensing opportunities.
- Proactively monitor L&A environment to continuously adapt and
deliver L&A quality support strategies that maximize quality input to
business partners to assure the best possible assets and companies are being
acquired by Johnson & Johnson.
- Function as a member of cross-functional due diligence teams led
by Janssen Business Development (JBD) to lead and coordinate GLP, GCP and
medical safety compliance assessment activities with business partners &
interface with JBD/Scientific Licensing project leads to report potential
quality risks for consideration during L&A or M&A.
- Lead cross-GxP initiatives to enhance the overall Pharma L&A
support strategy as assigned by the Head of Licensing & Acquisition in
support of L&A End to End strategy.
- Manage the coordination of and participate in (as applicable)
Johnson & Johnson Enterprise sponsored post-acquisition assessment (PAA)
activities in compliance with corporate quality policies.
- Review and provide BRQC Janssen input for L&A, M&A, and
out-licensing contract negotiations as part of the Janssen Business Development
team to assure quality language is included to allow for appropriate mitigation
activities post signing.
- Manage a BRQC Janssen library of quality language to be suggested
for master service agreements during the L&A contracting process.
- Lead the discussion, development and approval of clinical quality
agreements between counterparts from co-development organizations (e.g.
Pharmaceutical companies, Cooperative Groups, Governmental Agencies) and key
internal stakeholders (e.g. BRQC Janssen, Therapeutic Areas, Global Clinical
Development Organization etc.) to establish a quality oversight framework for
assets jointly developed between Janssen R&D and external organizations.
- Manage cross-functional teams of key Pharma segment R&D
business partners to drive the BRQC Janssen post-signing assessment process
including planning, execution and tracking of key quality risks for newly
- Coordinate with BRQC Janssen leaders to provide resource estimates
for support of L&A, M&A, and/or out-licensing mitigation and base
business activities post deal signing as necessary.
- A minimum of a Bachelor’s degree (Science, Engineering or Business
preferred) or equivalent is required
- A graduate degree (M.B.A., M.S., etc.) is desired.
- A minimum of 8 years’ experience in a highly matrixed, FDA
regulated environment is required
- Knowledge of multidisciplinary areas of clinical development is
highly preferred, including but not limited to: clinical operations, pharmacovigilance
reporting, regulatory operations, contract development, clinical trial
portfolio planning etc.
- Experience managing multiple projects simultaneously is required.
- Experience making decisions independently and ensuring
confidentiality of business critical activities is preferred.
- Strong knowledge of the drug development process, worldwide/applicable
GCP compliance regulations, and quality evaluation techniques are preferred
- Knowledge of clinical trial medical safety requirements is preferred
- Strong knowledge of the drug development process, worldwide GCP
compliance regulations, GxP quality systems, and data integrity is highly
- Familiarity with legal and financial good business practices is
- Previous experience focusing on Licensing, Mergers and Acquisitions
(L&A/M&A) in the pharmaceutical industry is a plus.
- This position can be based remotely anywhere in the US or onsite
at any Johnson & Johnson site in the US. The position will also require up
to 25% travel.
United States-Pennsylvania-Spring HouseOther Locations
North America-United StatesOrganization
Janssen Research & Development, LLC. (6084)Job Function