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Associate Director, Legal and Compliance

Posted Feb 17
Full Time
HybridWaltham, Massachusetts

Company Description

Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.

Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates. QINLOCK® (ripretinib) is Deciphera’s switch control inhibitor developed for the treatment of fourth-line GIST. QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Switzerland, Taiwan, the United States, and the United Kingdom.  We wholly own QINLOCK and all of our drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in Greater China. In addition to QINLOCK, we have identified and advanced multiple product candidates from our platform into clinical studies, including vimseltinib and DCC-3116.  

See here for more details on our portfolio.

We offer an outstanding culture and opportunity for personal and professional growth based on our “PATHS” Core Values:

  • Patients – We are committed to improving the lives of patients living with cancer. They are the driving force behind everything we do.
  • Accountability – We demand accountability for our actions, behaviors, and performance. We recognize our duty to maintain a culture that embraces the uniqueness of our people and finds strength in our differences.
  • Transparency – We strive to provide full visibility to internal and external stakeholders for a complete picture of what we are doing and why.
  • Honesty and Integrity – Trust and mutual respect are essential aspects of our culture. We act with honesty and integrity in all facets of our business, and this serves as the foundation of our work and interactions with others.
  • Stewardship – We are respectful of the resources entrusted to us by the investment community. We act thoughtfully and allocate resources responsibly in seeking to create value for our shareholders.  

“How” we work together and the behaviors that we show up with each day are critical to maintaining our positive culture. Our behavioral expectations align with our values to elevate and drive individual and team performance:  

  • Lead from where you are – regardless of role or level, we motivate each other to achieve common goals.
  • Drive business results – we navigate forward with our eye on the highest priorities.
  • Partner and collaborate – we cultivate relationships and value ideas, regardless of where they are coming from, to achieve more together.
  • Continuously evolve and improve – we try, we learn, we revise and try again.

 

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.

 

Qualifications

  • Knowledge of laws and regulations applicable to pharmaceutical companies, including among other things, US fraud and abuse and false claims laws, and PhRMA Code on Interactions with Healthcare Professionals.
  • Minimum of 5-7 years relevant professional experience in biopharmaceutical company, law firm, and/or life sciences industry
  • Must be able to partner cross-functionally and work collaboratively in a team environment on a broad range of matters with a wide variety of company personnel, including physicians, scientists and individuals of different nationalities.
  • Ability to manage multiple tasks simultaneously, to work independently and manage discrete areas of responsibility with little direct supervision, and to flourish in a fast-paced and high energy 
  • Ability to work proactively, both independently and collaboratively, in a team environment
  • Ability to communicate clearly and effectively
  • Strong professionalism and commitment to ethical conduct; ability to handle confidential and proprietary information using excellent discretion and judgment.

 

Preferred Skills:

  • Excellent interpersonal skills to develop and maintain strong relationships across multiple functional teams; Strong service-oriented disposition
  • In-house experience at a biopharmaceutical company preferred
  • Excellent analytical and written communication skills, along with strong legal drafting capabilities
  • Skilled at managing outside counsel
  • Proficient skills in MS Suite applications (Word, Excel, PowerPoint, Outlook), ChemDraw, SciFinder and other IP software

 

Additional Information

What Deciphera will Bring:

Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes the following:

  • Non-accrual paid time off
  • Summer vacation bonus
  • Global, company-wide summer and winter shutdowns
  • An annual lifestyle allowance
  • Monthly cell phone stipend
  • Internal rewards and recognition program
  • Munch and learns
  • Medical, Dental, and Vision Insurance
  • 401(k) retirement plan
  • Life and Supplemental life insurance for family 
  • ESPP offering
  • Health savings account
  • Flexible spending account for either health care and/or dependent care.

Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas and our European operations are run out of Switzerland.

 

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially.  Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.

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