Associate General Counsel
The Senior Commercial/Associate General Counsel will provide a wide range of contracts and legal support for Karius, which operates in a...
The Senior Commercial/Associate General Counsel will provide a wide range of contracts and legal support for Karius, which operates in a highly-regulated clinical laboratory and medical research environment. The will be the second legal role in the company, reporting to the General Counsel.
She/he will lead the contracts function and manage all commercial agreements. In addition, she/he will lead legal and compliance support for the Product, Marketing and Commercial teams, working closely with these functions by participating in business strategy/concept reviews and providing sound legal/compliance advice.
You Will:
· Review, revise, draft, negotiate and advise on complex contracts, such as collaboration, clinical study, advisor/speaker, consultant and service agreements; lead creation and implementation of efficient contracts management processes and systems
· Provide legal advice on health care compliance laws (including state/federal anti-kickback statutes and False Claims Act) consistent with industry guidance and practices; lead legal processes directed to appropriate interactions with health care providers, payers, patients and other stakeholders.
· Provide balanced legal guidance to Product and Marketing teams on marketing strategies, product launches, to promotional/advertising matters to ensure compliance with all applicable regulations.
· Participate in the drafting, review, training, implementation and oversight of compliance policies and SOPs, as required.
· Lead periodic compliance meetings, risk assessments, audits and training efforts in cooperation with other team members; work collaboratively with other stakeholders to create a culture of compliance across the company; drive efforts to track progress and summarize efforts for senior management.
· Help define the company’s risk tolerance and proactively lead efforts to create effective and efficient risk management programs; participate in the assessment and resolution of operational issues as needed.
· Remain current on laws, rulings, guidance, regulations and government programs affecting Karius’s commercial operations and help implement appropriate actions.
You Bring:
· JD degree and member in good standing of a U.S. bar, with a minimum of 7 years of experience working in a corporate legal environment or major law firm; certification/experience in health care compliance preferred
· At least 5 years experience in contracts administration, including managing contracts team members and/or outside counsel
· At least 3 years experience in a health care environment, preferably in diagnostics, medical device or pharmaceuticals; ability to recognize and seek input on a wide range of potential risks common to our industry, including health care compliance, privacy, human subject research, intellectual property, data ownership, and regulatory requirements
· Sound legal judgment, with ability to problem-solve in an intense, fast-moving environment; ability to take projects from start to finish on time and with minimal supervision
· Excellent drafting and legal technical skills; strict attention to detail
· Strong written/oral communication and interpersonal skills; ability to educate team members while resolving legal/compliance matters; enjoys participating in cross-functional efforts
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