Associate Director, Corporate Counsel, Research & Development
Company: Kyowa Kirin
Location: Princeton
Posted on: October 20, 2024
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Job Description:
Kyowa Kirin is a fast-growing global specialty pharmaceutical
company that applies state-of-the-art biotechnologies to discover
and deliver novel medicines in four disease areas: bone and
mineral; intractable hematologic; hematology oncology; and rare
disease. A Japan-based company, our goal is to make people smile by
delivering breakthroughs where no adequate treatments currently
exist, working from drug discovery to product development and
commercialization. In North America, we are headquartered in
Princeton, NJ, with offices in California, Massachusetts, and
Ontario.
Summary of Job:
The Associate Director, Corporate Counsel, Research & Development
(R&D) is responsible for legal expertise and support for
contracts and regulatory advice. This position provides legal
expertise and support across all business functions engaged in
registered clinical trials (Phases 1-4), and other evidence
generation activities including investigator-initiated trials, real
world evidence, translational research, health economics and
outcomes research. The position will need to frequently interact
with senior level staff, as well as other constituents within the
Company (both within the US and globally) and externally to ensure
complete alignment with respect to contract development, approval,
and execution, and compliance with laws and regulations governing
drug development and evidence generation. In addition, this
position will assist with various projects, litigations, and
investigations within the Legal Department as needed.
Essential Functions:
Job Requirements:
Education
BA/BS required. A Juris Doctorate degree from Accredited Law School
is required. Admission to the N.J. State Bar or eligible to obtain
a N.J. limited license for in-house counsel.
Experience
At least five (5) years legal experience supporting life science
clients with contracting and legal issues related to research and
development and evidence generation. In-house experience a plus.
Must have a good understanding of the pharmaceutical industry and
related regulatory environment.
Experience with cross-functional teams (including ex-US) and
demonstrated ability to collaborate effectively with others to
address complex legal, compliance and operational issues.
Experience drafting and negotiating contracts such as master
servicer agreements, statements of work, confidentiality
agreements, clinical research agreements, contract research
organization agreements, clinical supply agreements, consulting
agreements, clinical trial site agreements and related agreements
including collaborative research with industry and government
partners and other corporate pharmaceutical-related agreements is
required.
Must understand contract law and have effective communication and
negotiation skills and the ability to influence and work
collaboratively at all levels and across functions. Proven ability
to interpret and apply legal requirements to specific projects and
agreements.
Demonstrate understanding of the U.S. Legal requirements related to
the pharmaceutical industry, with focus on research and development
and evidence generation.
Strong grasp of relevant federal and state laws, regulations,
rules, and guidance as well as industry codes and principles
impacting pharmaceutical manufacturers, focused on FDA laws and
regulations fraud, and abuse (Anti-kickback statute, product
liability and pharmacovigilance. Knowledge of enforcement
landscape, including relevant industry investigations, litigation,
and settlements. Strong grasp of relevant federal and state laws,
regulations, rules, and guidance as well as industry codes and
principles impacting pharmaceutical manufacturers, focused on FDA
laws and regulations fraud, and abuse (Anti-kickback statute,
product liability and pharmacovigilance).
Knowledge of enforcement landscape, including relevant industry
investigations, litigation, and settlements.
Technical Skills
Advanced proficiency in MS Office Suite (Word, Excel, Outlook)
Non-Technical Skills
Demonstrated ability to organize, prioritize, meet deadlines, make
decisions, and change course of action quickly. Strong
interpersonal and communication skills including negotiation
skills. Strong work ethic is required. Detail oriented and
excellent follow through. Has the ability to flex and deal with
ambiguity in a dynamic, fast-paced, high growth environment. Has a
passion for personal learning and development to be able to grow
with the company. Cultural sensitivity and ability to develop
consensus within a multinational organization.
Physical Demands: Normal office environment with prolonged sitting
and extensive computer work.
Working Conditions: Requires up to 10% domestic and international
travel
KKNA and all of its employees have an obligation to act in
accordance with the law and with integrity in all our operations
and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide
equal employment opportunity to all qualified persons without
regard to race, religion, creed, color, pregnancy, sex, age,
national origin, disability, genetic trait or predisposition,
veteran status, marital status, sexual orientation or affection
preference or citizenship status or any other category protected by
law.
When you apply to a job on this site, the personal data contained
in your application will be collected and stored by Kyowa Kirin,
Inc. ("Controller"), which is located at 510 Carnegie Center Dr.
Princeton, NJ 08540 USA and can be contacted by emailing
kkus.talentacquisition.8h@kyowakirin.com. Controller's data
protection officer can be contacted at
usprivacyoffice@kyowakirin.com. Your personal data will be
processed for the purposes of managing Controller's recruitment
related activities, which include setting up and conducting
interviews and tests for applicants, evaluating and assessing the
results thereto, and as is otherwise needed in the recruitment and
hiring processes. Such processing is legally permissible under Art.
6(1)(f) of General Data Protection Regulation (EU) 2016/679
("GDPR") as necessary for the purposes of the legitimate interests
pursued by the Controller, which are the solicitation, evaluation,
and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a
cloud services provider located in the United States of America and
engaged by Controller to help manage its recruitment and hiring
process on Controller's behalf. Accordingly, if you are located
outside of the United States, your personal data will be
transferred to the United States once you submit it through this
site. The transfer will be made using appropriate additional
safeguards under the standard contractual clauses approved by
regulators for transfers of personal data outside the European
Union.
Your personal data will be retained by Controller as long as
Controller determines it is necessary to evaluate your application
for employment. Under the GDPR, if you are located in the European
Union, you have the right to request access to your personal data,
to request that your personal data be rectified or erased, and to
request that processing of your personal data be restricted. You
also have the right to data portability, and to lodge a complaint
with an EU supervisory authority. If you have any questions about
our use of your data, you may contact us by email at
usprivacyoffice@kyowakirin.com.
Recruitment & Staffing Agencies
Kyowa Kirin does not accept agency resumes unless contacted
directly by internal Kyowa Kirin Talent Acquisition. Please do not
forward resumes to Kyowa Kirin employees or any other company
location; Kyowa Kirin is not responsible for any fees related to
unsolicited resumes.
#LI-Hybrid
#LI-JC1
Keywords: Kyowa Kirin, Vineland , Associate Director, Corporate Counsel, Research & Development, Executive , Princeton, New Jersey
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