Circassia is a specialty pharmaceutical business with an established commercial infrastructure and marketed products targeting major market opportunities. Circassia sells its novel, market-leading NIOX asthma management products directly to specialists in the United States, China, United Kingdom and Germany. Its products are also sold in other countries through a network of partners.
In the United States, the company also commercialises the pharmaceutical products Duaklir and Tudorza for the symptomatic treatment of chronic obstructive pulmonary disease (COPD), as part of a collaboration with AstraZeneca.
In early 2019, Circassia entered into a license, development and collaboration agreement with AIT Therapeutics, Inc. giving the company the exclusive rights to commercialise in the United States and China AirNOVent, a novel ventilator-compatible inhaled nitric oxide product for use in the treatment of hypoxic respiratory failure associated with persistent pulmonary hypertension of the newborn (PPHN). Circassia anticipates launching the product in the first half of 2020.
For more information on Circassia please visit www.circassia.com.
In order to support these activities we are currently seeking a Commercial Counsel.
Key Responsibilities of Role
The Commercial Counsel will be the immediate source of legal support for Circassia's US business which is focused on the sale of its proprietary NIOX devices and tests for the management of asthma, on the pharmaceutical products Tudorza and Duaklir for COPD and, from 2020 onwards, AirNOVent.
This role will be based at the Morrisville offices although there is likely to be occasional travel in the United States and to the company's global headquarters in Oxford, UK.
On a day to day basis, the Commercial Counsel will work closely with the Commercial, Market Access, Medical Affairs, Compliance and Regulatory teams. The successful candidate will also collaborate with colleagues in many other functions including the Quality, Business Development, HR, and Finance teams.
To be a strong business partner to the SVP & General Manager, US Operations; the heads of the commercial business units; and colleagues in other key functions including Market Access, Medical Affairs, Trade Distribution, Finance, Compliance and Regulatory Affairs, all of whom are based in the Morrisville office.
Provide expert legal counsel and guidance on a broad range of commercial issues, including negotiation and drafting of a broad range of commercial contracts (e.g. sales agreements, consulting agreements, clinical trial/investigator-initiated study agreements, IP licensing and product acquisition agreements).
Work with the Key Account team to negotiate and draft contracts with the company's major customers.
Work with the Market Access team to understand federal and state payer regulations and negotiate contracts which reflect the preferred strategies on co-pays, rebates, and other structures.
Work with the Trade and Distribution team to negotiate contracts with wholesalers.
Work with outside partners to the commercial business to ensure that Circassia remains in full compliance with state by state regulations of pharmaceutical and device licensing and distribution
As a member of cross-functional committees (including, in particular, the Promotional Review Committee), provide expert legal counsel and guidance on, inter alia, product promotional materials and the pricing of pharmaceutical and medical devices.
Provide ad hoc legal advice for the activities of other functions within Circassia such as the Regulatory, Quality, IT, Finance, and HR departments.
From time to time, assist the General Counsel on important corporate projects (M&A, licensing, commercial disputes).
Be a leader regarding the Company's values and a strategic business partner and influencer to internal clients.
Independently manage legal work.
Assist the Director of Compliance to ensure compliance with all applicable laws and regulations and stay abreast of laws and developing external trends.
Educate and train staff on important legal issues relative to areas of responsibility.
Develop and maintain communication and collaboration with other legal team members to ensure a seamless global service to the organisation and the sharing of best practice.
Manage external counsel where agreed with the General Counsel.
Other duties as assigned.
Qualifications and/or Experience Required to Perform the Role
BA required. MBA or master's degree preferred.
Juris Doctorate from a reputable accredited US law school.
Admitted to practice law in North Carolina or a reciprocal state.
+ years of legal experience in a well-renowned law firm and/or the legal department of a company. (Experience in the pharmaceutical and medical devices sectors would be ideal).
Experience in healthcare laws including those relating to the manufacture, approval, regulation, sale and marketing, pricing and reimbursement of medical device and/or pharmaceutical products.
Experience with contract negotiation and drafting, ideally with distribution and wholesaler agreements, specialty agreements and rebate agreements, federal contracts, contracting and negotiating with Group Purchasing Organization (GPOs).
Proven skill in providing clients with prompt and strategic advice on complex legal issues.
Excellent interpersonal and communication skills with the ability to work as part as global team.
Ensuring that all interactions and engagements are carried out in a professional, efficient, courteous manner and that all work is accomplished with quality and in accordance with Circassia's values.
Self-sufficient, willing and able to function autonomously.
Highly organized with an ability to manage and prioritise work load in a proactive manner.
Strength of character to work effectively under pressure, sometimes to short deadlines and in a rapidly growing and changing environment.
Ability to apply common sense, good judgment and a strong commercial outlook to make independent decisions in accordance with knowledge of the business and those supported.
Ability to identify and manage business risks within the context of the legal sphere of activity.
Exceptional ethical standards and the ability to be very discreet in the handling of confidential and privileged information.
Full knowledge of Microsoft Office, including proficiency in Word and basic PowerPoint and Excel.
Ability to travel up to 20%
The flexibility to adapt to changing circumstances and manage activities to meet the needs of the business while maintaining a focus on quality.
EOE Minorities/Females/Disability/Veterans; VEVRAA Federal Contractor