Job Description

Head Of Compliance

In the role of Head of Compliance, you will be responsible for the development, implementation and evolution of a business-enabling compliance program to align with and support the requirements of industry laws, rules, regulations and guidance. You will partner closely with our teams in Commercial, Medical Affairs, Regulatory, Global Quality, Market Access & Trade, Patient Advocacy, Human Resources and Finance, among others. To be successful in this role, you must collaborate with commercial and business colleagues to develop, implement and evolve Celldex's compliance program through the creation of written policies and procedures, leading effective training programs, conducting internal monitoring and auditing, and directing investigations to respond promptly to detected offenses and undertake corrective actions. You will work closely and cross-functionally with operating units throughout our organization to lead and support compliance initiatives, and to raise the level of awareness of compliance within our organization. You will have excellent interpersonal and project management skills, while cultivating a culture that possesses a strong commitment to diversity, inclusion and community.

Responsibilities

• Establish, implement and lead Celldex's compliance program in accordance with federal, state and industry regulations and developing industry guidelines and trends.
• Ensure the compliance program is effectively integrated into the culture and business operations at Celldex, with the capacity to scale rapidly, through effective engagement, training, auditing, and monitoring.
• Provide strategic compliance advice to the business to ensure compliance with applicable U.S. laws and company policies, including federal and state antikickback and false claims laws, the federal Food, Drug, and Cosmetic Act (FDCA) laws, the PhRMA Code, state laws, federal and state transparency laws, privacy laws, and antitrust laws.
• Draft, implement and train on company compliance policies in coordination with colleagues in the global quality organization.
• Collaborate closely with colleagues across the organization to direct compliance issues through the appropriate channels for investigation and resolution as well as work towards future improvements as the compliance program evolves.
• Provide strategic compliance input, in partnership with legal colleagues, on certain agreements and contracts with health care providers and related institutions.
• Assess and report on the current state of compliance of the company to senior management and the Audit Committee of the Board, identify potential areas of compliance vulnerability and risk, provide guidance and advice on compliance issues and mitigation of compliance risks.
• Manage compliance budgets.
• Other duties as assigned

Qualifications

• Undergraduate degree required; J.D. preferred.
• Minimum of 10 years of experience with a biotech and/or pharmaceutical company with a deep understanding of compliance issues confronting the industry, and with handling corporate and sales force promotional compliance.
• Demonstrated track record of having built and led a dynamic compliance function.
• Knowledge of US, UK and EU pharmaceutical industry standards (i.e., HHS OIG Guidelines, PhRMA Code, US Sentencing Guidelines, Food, Drug, & Cosmetic Act, False Claims Act, Anti-Kickback Statute, etc.).
• Knowledge of ABAC regulations and business standards (i.e., US Foreign Corrupt Practices Acts, UK Bribery Act, OECD Anti-Bribery Convention Recommendations of 2009, etc.).
• Knowledge of US, EU and UK data protection laws and regulations (i.e. HIPAA, EU and UK GDPR).
• Demonstrated ability to seek out, understand, and pragmatically apply relevant regulatory and compliance developments, and a talent for helping others to understand how these developments impact their own work.
• High level judicial and analytical capabilities.
• Unimpeachable Integrity/Ethics.
• Effective leadership, training and coaching skills, including the ability to energize and motivate staff.

Compensation

The expected base salary range for this position is $233,631 to $348,929. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.

Compensation for this role includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page. Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.

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