Director, Commercial Counsel

At Collegium Pharmaceutical, we are building a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. We have a portfolio of meaningfully differentiated medications to treat serious medical conditions, including severe and persistent pain and ADHD.

Hybrid: Required to be onsite in Stoughton, MA on Tuesday, Wednesday and Thursday.

POSITION OVERVIEW 

The Director, Commercial Counsel (“Director”) will serve as the Legal department’s representative and reviewer/approver on Collegium’s Materials Review Committee (“MRC”) to ensure all advertising, promotional, and medical materials and communications related to Collegium products in neurology disease area comply with all applicable federal and state laws (including but not limited to the Federal Food, Drug, and Cosmetic Act, the Lanham Act, and the federal False Claims Act) and any regulations/guidance promulgated thereunder, and to reduce as far as feasible any potential risk to the Company.  The Director will also ensure that all materials subject to MRC review and approval comply with Collegium internal policies and procedures and, where applicable, escalate issues to the Sr. Director, Commercial Counsel (“Sr. Director"). 

The individual in this position will also manage Collegium’s commercial contracting processes in alignment with Collegium’s priorities and strategies. To that end, this role will have the opportunity to interact with a wide cross-section of the organization, including Market Access & Trade, Sales and Marketing, Commercial Operations, Commercial Finance and the Compliance department. The Director will be responsible, in conjunction with the Sr. Director, for the drafting, review, negotiation, execution and maintenance of contracts relating to Collegium’s business and external customers, including managed care payers/PBMs, government payers (Medicaid, Medicare Part D, VA/DOD), wholesalers, external consultants and a variety of other vendors.  Additionally, the Director will oversee the administration and maintenance of the organization’s contract lifecycle management system. The Director will also be responsible for assisting the Sr. Director on various other legal projects, as needed.

RESPONSIBILITIES

• Participate as the Legal representative on Collegium’s Materials Review Committee for the neurology franchise
• Collaborate with Sr. Director, Compliance, and other MRC stakeholders, including Medical and Regulatory, to develop and maintain appropriate risk tolerance strategy related to Collegium’s advertising and promotional, medical, and disease state materials for the neurology franchise
• Maintain up-to-date knowledge of laws, regulations and agency guidance documents, as well as enforcement and compliance landscape as it relates to advertising and promotion of commercial stage pharmaceutical products. Advise appropriate departments within the company of these requirements
• Draft, review, and negotiate commercial contracts in partnership with key stakeholders and external parties (including outside counsel) as necessary, advising the business on any legal, regulatory, and/or compliance matters implicated and escalating potential issues to the Sr. Director
• Maintain and oversee Collegium’s contract lifecycle management system to monitor and enforce all active executed contracts (including membership/affiliation lists, amendments, insurance requirements, renewals, etc.) and support relevant stakeholders over the lifecycle of contract, including by advising on renewals and terminations
• Develop and implement policies, procedures, and trainings to support and facilitate compliant and efficient contract review, approval, and archiving.
• Provide cross-functional Legal support to the business and bridge critical connections within the organization to solve complex problems and develop new ideas
• Uphold and consistently demonstrate Collegium’s Core Values and Leadership Behaviors
• Assist Sr. Director with ad hoc Legal/Compliance projects, as needed
• Provide internal Legal support and coverage in the absence of the Sr. Director, including Legal review of the pain franchise materials submitted to MRC, Collegium business portfolio materials, and/or corporate communications materials.

REQUIRED LEADERSHIP BEHAVIORS 

Leadership Behaviors are a core set of behaviors that vary based on Level in the organization. We have categorized these under Head, Heart, and Guts.

• Head
  • Know our Business
  • Think Critically
  • Decide
  • Execute
• Heart
  • Collaborate
  • Develop
  • Communicate
  • Embrace Authenticity 
• Guts
  • Be Disruptive
  • Innovate
  • Evolve
  • Be Tenacious

QUALIFICATIONS

• Bachelor’s and JD degree required
• 6-8 years of experience in the Pharmaceutical or Life Sciences industry required with a minimum of 2+ years of legal experience with promotional review of materials for a commercial-stage pharmaceutical product(s)
• 2 years of experience in a commercial contracting role, with understanding of key contract provisions across various commercial functions and experience with contract lifecycle management software
• Ability to communicate complex concepts clearly and concisely
• Ability to efficiently manage and oversee both large and small-scale projects in a timely manner
• Ability to collaborate with internal and external stakeholders to form and maintain productive partnerships

Collegium is an equal opportunity employer. It is the policy of Collegium, in all of its relations with its employees and applicants for employment, to base all employment-related decisions upon valid job-related factors, without regard to age, national origin, citizenship status, ancestry, race, color, religion, creed, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or expression (including transgender status), sexual orientation, military or veteran status, physical or mental disability, genetic information, or any other status protected by applicable federal, state, or local law. This policy applies to hiring, training, promotion, compensation, disciplinary measures, access to facilities and programs, and all other personnel actions and conditions of employment. By this policy, Collegium seeks to ensure that all employees have the opportunity to make their maximum contribution to Collegium and to their own career goals. This policy provides for an equal employment opportunity program that will simultaneously serve the requirements of society, the law, sound business practices and individual dignity.

If you have questions or concerns about equal employment opportunities in the workplace, you are encouraged to bring these issues to the attention of the Head of Human Resources. We will not allow any form of retaliation against employees who raise issues of equal employment opportunity. To ensure our workplace is free of artificial barriers, violation of this policy may result in disciplinary action, up to and including termination.