Astellas Pharma Senior Director, Healthcare Compliance in San Francisco, California
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Senior Director Healthcare Compliance opportunity at their new affiliate Audentes in San Francisco, CA.
Purpose & Scope:
The Senior Director, Healthcare Compliance, as the Company's primary individual responsible for ensuring a strong compliance culture within Audentes, an Astellas company, and is accountable and responsible for designing, implementing and enhancing the Company's compliance program in close collaboration with the Executive Director, Healthcare Compliance, Development & Research. The Senior Director is a strong leader and promotes a highly ethical, compliant and accountable culture that encourages and enables employees to raise potential or actual compliance concerns.
Essential Job Responsibilities:
Key accountabilities and responsibilities include the following in close collaboration with and at the direction of the Executive Director, HCC, E&C, Development, Research, Innovation:
- Effectively implementing the global and US-specific compliance standards through strategic planning, oversight and effective communication, training and monitoring of policies, controls and initiatives.
- Develops strategy for, oversees and leads healthcare compliance projects/initiatives for Audentes in alignment with a global ethics and compliance , interacting closely with local, divisional and global Ethics & Compliance teams to ensure adherence to laws, regulations, industry codes, policies, and processes that promote best practices.
- Responsible for making strategic independent decisions, requiring the ability to both recognize issues and develop creative solutions to drive results.
- In collaboration with business stakeholders, makes recommendations to divisional and global Ethics & Compliance leaders on opportunities for improvements and enhancements.
- Leads implementation of strategies to continually enhance and maintain a highly ethical, compliant and accountable culture.
- Regularly meets with Audentes business leaders and participates in and provides advice for strategic business projects/initiatives.
- Coordinates and collaborates closely with the Commercial Healthcare Compliance team in order to develop strategies for an effective integrated healthcare compliance program in the region and at a local level consistent with global strategies/policies/processes; ensures that the ethics and compliance support is well coordinated, responsive to the business and in adherence with the Company's highest ethical and compliance standards.
- Provide strategic leadership, counseling, advice, training, and support related to compliance, quality policy and practice, and other related compliance implications for the enterprise, including support for Commercial Operations, Medical Affairs and Corporate Affairs.
- Support publication policy, process, systems, and oversight to deliver timely dissemination of key publications.
- Lead, manage and oversee the full range of compliance support, advice and counseling for activities supported by Audentes, including: providing timely, proactive, strategic, best-in-class advice and support, taking into account the global, regional and local objectives of the organization in a risk-balanced manner in order to effectively minimize and mitigate risk; and developing strategies, policies, procedures and governance taking into account specific requirements for the business functions at Audentes; Lead complicated transformation of the Astellas compliance programs to meet the evolving needs of Audentes programs, including expanding the compliance programs =and assess this transformation in comparison to the current compliance programs.
- Develops strategies for and ensures effective implementation, maintenance and continuous enhancements of controls (processes and systems) relating to the review and approval of interactions with HCPs and/or HCOs.
- Develops strategy for and leads collaboration with Audentes business partners on healthcare compliance matters in the US.
- Collaborates with US monitoring team to share insights, observations and knowledge of ongoing and developing business strategies in order to ensure learnings are incorporated into the monitoring activities at the local and regional level and to ensure that any corrective actions and/or enhancements are tailored to ensure highly ethical and compliant business conduct.
- Collaborates with cross-functional teams locally, divisionally and globally to influence the Healthcare Compliance strategy to ensure alignment with the US and support development and expertise within Ethics & Compliance.
- Researches, benchmarks and stays current with applicable legal and regulatory developments, industry standards and the changing healthcare landscape to determine emerging compliance trends and incorporates such developments, standards and trends into education for the non-commercial healthcare compliance team at the regional and local level as well as the compliance strategies and advice provided to the business.
- Coordinate and collaborate with the local, regional and global operations teams with respect to the auditing, monitoring, training and communications needs of the business, including proactively identifying such needs and opportunities for enhancement, and developing and implementing appropriate training and education programs.
- Other Ethics & Compliance initiatives deemed necessary to further enhance Astellas' commitment to high ethical standards and compliance with the law.
- Responsible for operating within the regional compliance budget, and any applicable project specific budgets.
- Directly reports to the Executive Director, E&C, HCC, Development, Research & Innovation.
- Works closely and collaborates with Ethics & Compliance global and regional leadership, operations and Anti-bribery and Anti-corruption lead
- Leads and ensures the effective implementation of the Healthcare Compliance program in the US and closely coordinates with Ethics & Compliance counterparts across the globe
- Works closely and collaborates with senior leadership of all functions across the US
- Minimum of 10 years' of experience in biotech Compliance or related functions (e.g., regulatory, legal, audit, or risk).
- Advanced degree (Juris doctor; Masters; Ph.D.) or advanced compliance certifications (CCEP or equivalent).
- Expertise in compliance with law, regulations and industry codes relevant to the pharmaceutical industry. Significant knowledge of the best practices relating to compliance in highly regulated industries.
- Proven ability to lead high-level, broad-based objectives in the context of annual compliance objectives.
- Strong analytical, organizational, problem solving, and follow-up skills. Ability to interpret rules and guidelines, and ability to conceptualize policies, procedures and controls.
- Ability to self-start and self-direct work in a fast-paced environment.
- Excellent project management skills. Ability to prioritize and work simultaneously on multiple projects, strong attention to detail, and ability to organize and analyze complex information and data.
- Demonstrated experience leading compliance operations projects and activities in a matrixed, global organization.
- Excellent written and verbal executive-level communication skills.
- Adaptability necessary to work effectively in a sometimes ambiguous, changing, and matrix global environment.
- Exceptional ethics and commitment to integrity, interpersonal skills, professionalism, and collegiality.
- Does not confuse effort for results.
- Tenacity to weather short-term setbacks for long-term advantages.
- Ability to demonstrate sound and independent judgment, prudence and maturity in complex and sensitive cases.
- Client orientation with a constructive approach to resolution of issues. A style which builds alliances within the organization, locally/globally, and/or corporate collaborators.
- Experience working globally
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Ethics and Compliance