About this opportunity
Deciphera Pharmaceuticals lists this Director, Legal Compliance opportunity in waltham, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Overview
The Director, Legal and Compliance, serves as a trusted strategic partner and is responsible for providing practical and thoughtful legal counsel to the Commercial, Medical Affairs, Market Access, and Patient Support functions in support of assigned products. This role is the subject matter expert on U.S. healthcare laws, FDA promotional regulations, and industry codes to enable compliant launch readiness and ongoing commercialization activities for the assigned product. The role ensures that the Company’s U.S. compliance program remains risk-based, fit-for-purpose, and aligned with corporate values, while supporting cross-functional teams through advisory responsibilities, training, and policy development.
Key Responsibilities
Commercial & Medical Affairs Legal Support (35%) Serve as key legal partner and SME to commercial and medical teams on established and launch products
Provide practical legal advice on launch strategy, disease awareness, marketing campaigns, patient programs, and all other business activities supporting the product
Review Committee Participation (20%) Act as Legal representative on Promotional Review Committee, Medical Review Committee, ISR reviews, grants and sponsorships committees for established and launch products
Patient Support & Market Access Compliance (20%) Advise patient support team on legal issues related to patient support, hub services, and reimbursement programs
Counsel market access on PIE, FDAMA 114; draft and review commercial and patient support agreements
Compliance Program Development (10%) Advise commercial, medical, and advocacy teams on compliance obligations
Evolve the U.S. compliance program to remain right-sized and aligned with company values
Training & Education (5%) Prepare and deliver training on compliance responsibilities, ethics, policies, and procedures
Policies & SOPs (5%) Support development and enhancement of compliance policies and SOPs related to AKS, FCA, and industry codes
Transparency Reporting (3%) Support U.S. federal and state transparency reporting and assist business leadership with reporting obligations
Cross-Functional Legal Support (2%) Coordinate legal support as a cross-functional partner with business and Law Department colleagues
Qualifications
JD required with 12+ years of relevant legal/compliance experience in the biopharmaceutical industry
Deep knowledge of FDA promotional regulations, Anti-Kickback Statute, False Claims Act, OIG guidance, and industry codes
Experience providing legal or compliance support to Commercial, Medical Affairs, Market Access, and/or Patient Support functions
Experience reviewing promotional and medical materials as a Legal or Compliance reviewer
Ability to interpret and apply healthcare laws to complex business activities
Preferred Capabilities
Experience in commercial and medical compliance in a pharmaceutical environment
Experience supporting product launch planning and cross-functional review committees
Strong business partnering orientation with ability to balance risk and business goals
Excellent written and verbal communication skills
Ability to manage multiple priorities in a fast-paced environment
Additional Information
Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $191,000 - $236,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera’s competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable).
Benefits
Competitive salary and annual bonus
Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more
Generous parental leave and family planning benefits
Outstanding culture and opportunities for personal and professional growth
Apply Today
Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!
Equal Employment Opportunity Information
Deciphera is committed to equal employment opportunity and values diversity. Providing this information is optional and will not affect your opportunity for employment. This information will be treated confidentially. We are committed to making all hiring decisions on a non-discriminatory basis.
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Worksite address
waltham, MA, 02254, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.