Associate Director, Legal and Compliance

3 weeks ago

Waltham Massachusetts, United States Deciphera Pharmaceuticals Full time
Job Description

What’s In It for You:

This is a wonderful opportunity to join Deciphera at critical growth period for the company in its pursuit to expand from a one product to two product commercial organization and continue to develop its robust pipeline.

Opportunity to join a best-in-class team to support a proven therapeutic in oncology rare disease and ready the marketplace for a launch brand

Join a close-knit team to drive results for the betterment of patient care

Reap the rewards of attractive incentive and benefits packages

Become part of Deciphera’s unique culture and make a difference in the lives of patients in need

The Role:

We are seeking an attorney to join our innovative and close-knit Legal and Compliance team at Deciphera Pharmaceuticals. This position will provide numerous development opportunities and report to and work directly with the Chief Compliance Officer. The successful candidate will be a motivated and enthusiastic individual with the drive and organizational skills to manage a variety of projects.

The position uniquely offers the opportunity to support company-wide needs at a growing, global, commercial biopharmaceutical company with one approved product (QINLOCK®) in the US and abroad, and with another product (Vimseltinib) that has recently successfully met its Phase III primary endpoint.  This candidate will primarily provide legal and compliance support to the Vimseltinib commercial and medical teams in preparation for launch but will also have the opportunity to provide company-wide healthcare compliance support, including supporting initiatives such as compliance training, transparency, HCP engagements, and monitoring.  The Associate Director will be expected to provide input on complex and sensitive legal and business issues and will advise internal stakeholders in a manner that advances the company’s strategy while addressing legal and regulatory risks. The Associate Director will be expected to provide prompt, strategic, and practical advice to internal clients and senior management regarding complex and wide-ranging legal matters, and serve as a subject matter expert in areas of healthcare regulatory law, including rules and regulations of the FDA, OIG and CMS and applicable anti-kickback, privacy, fraud and abuse, anti-bribery and product liability statutes and regulations.

What You’ll Do:

Serve as trusted business partner and subject matter expert to Commercial and Medical Affairs teams and provide advice on all strategy and tactics in preparation for launch, including disease awareness and marketing campaigns, patient support programs and patient education, etc.     

Act as the Legal representative on review teams for the assigned product,  including the Promotional and Medical Review Committees, ISR reviews, grants and sponsorships committees, etc.

Advise patient support team on patient programs, including hub services, call center operations, reimbursement assistance and field reimbursement activities for the assigned product.  Advise market access team on issues relative to PIE, FDAMA 114 and healthcare economics initiatives. Draft, review and revise commercial agreements related to patient support programs, distribution, and other market access activities.

Advise commercial, medical, and patient advocacy teams regarding compliance obligations and continue to evolve the US Deciphera compliance program to ensure that it is consistent with the values and principles of the company while remaining right-sized and appropriately scoped

Prepare and deliver training and education to ensure understanding of employee responsibilities and ethics and compliance issues, as well as related policies and procedures

Support development of and enhancement to policies and SOPs to ensure compliance with applicable laws, regulations and industry codes, including Anti-kickback Statute and False Claims Act

Support the maintenance of US federal and state transparency reporting requirements and assist business leadership in meeting reporting obligations

Coordinating legal support by contributing as a member of cross-functional team and interacting with business and law department colleagues on various matters

Contributors to Success:

Positive Energy: Strong work ethic with a can-do attitude. Strong collaborator who brings energy and inspiration.

Patient Focus: Motivation to work with urgency and go the extra mile. The patient is waiting.

Innovation: Open-mindedness and flexibility to embrace change.

Self-directed: Ability to work independently and accommodate last-minute requests. Ability to prioritize multiple tasks and respond effectively to rapidly changing priorities and deadlines.

Results Oriented: Consistent performance. Accountability for work product quality.

Strategic Thinker: Strong organizational skills. Ability to grasp the overall healthcare compliance landscape and provide fact-based counsel with an enterprise-focused mindset.

Approach to Problem Solving: Analysis and evaluation of issues. Identifying pros and cons of issues. Proactively proposing strategies and solutions.

Communications: Excellent written and verbal skills. Ability to communicate across disciplines and functions.

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