Executive Director, Compliance
My client is a Publicly-Traded Commercial Stage Biopharma Company that is seeking an experienced Compliance professional to drive the evolution and execution of the Compliance Program. The Company is poised for considerable growth having launched a first-in-class drug with a growing pipeline.
Position Summary:
The Executive Director of Compliance will play a pivotal role in scaling the Compliance function to support the company's commercial operations and global expansion. This leader will oversee the development and implementation of compliance policies, training programs, and systems, while serving as a strategic partner to Legal, Commercial, and Market Access teams.
Key Responsibilities:
- Lead the build-out and scaling of the Compliance department, including team structure, processes, and systems.
- Develop, implement, and maintain global compliance policies, procedures, and standards aligned with industry best practices and regulatory requirements.
- Support Commercial and Market Access teams with compliant execution of account reimbursement training and field activities.
- Oversee the implementation and management of a Compliance Management System (CMS), including monitoring, reporting, and auditing capabilities.
- Launch and manage a Third-Party Risk Management System to ensure appropriate oversight of vendors, partners, and affiliates.
- Provide strategic compliance guidance for product launches, promotional activities, and patient support programs.
- Collaborate cross-functionally to foster a culture of compliance and ethical business practices.
- Monitor evolving regulatory requirements and enforcement trends to proactively manage risk.
Qualifications:
- Bachelor's degree required; J.D., MBA, or advanced degree preferred.
- Minimum 12 years of experience in pharmaceutical or biotech compliance, with at least 7 years in a compliance role.
- Proven experience launching and managing compliance systems and third-party oversight programs.
- Strong understanding of U.S. and global healthcare laws, including OIG, DOJ, FCPA, and GDPR.
- Experience supporting commercial operations, including account reimbursement and field training.
- Exceptional communication, leadership, and project management skills.
- Ability to thrive in a fast-paced, entrepreneurial environment.
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