Astellas Pharmaceutical Jobs

Job Information

Astellas Pharma Senior Director, Astellas Gene Therapy, E&C, US in San Francisco, California

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

Purpose and Scope:

The Senior Director, Healthcare Compliance, as the Company's primary individual responsible for ensuring a strong compliance culture within Astellas Gene Therapy (AGT), 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:

  • Efficiently implementing the global and US-specific compliance standards through planning, oversight and effective communication, training and monitoring of policies, controls and initiatives.

  • Develops strategy for, oversees and leads healthcare compliance projects/initiatives for Astellas Gene Therapy (AGT) 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 get 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 AGT business leaders and participates in and provides advice for strategic business projects/initiatives.

  • Coordinates and collaborates closely with the global Healthcare Compliance teams 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 Patient Advocacy/Patient Centricity.

  • Support publication policy, process, systems, and oversight to deliver timely dissemination of key publications.

  • Lead, manage and supervise the full range of compliance support, advice and counseling for activities supported by Astellas Gene Therapy, 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 Astellas Gene Therapy; Lead complicated transformation of the Astellas compliance programs to meet the evolving needs of AGT 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 AGT business partners on healthcare compliance matters in the US and where appropriate interact with oUS HCC counterparts.

  • Collaborates with CET team to share insights, observations and knowledge of ongoing and developing business strategies in order to ensure findings 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 oUS HCC counterparts, as appropriate, 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 resolve 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 vital to further enhance Astellas' commitment to high ethical standards and compliance with the law.

Quantitative Dimensions:

Responsible for operating within the regional compliance budget, and any applicable project specific budgets.

Organizational Context:

  • 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

Qualifications Required

  • 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 sophisticated information and data.

  • Proven experience leading compliance operations projects and activities in a matrixed, global organization.

  • Excellent written and verbal executive-level skills.

  • Adaptability necessary to work effectively in a sometimes ambiguous, changing, and matrix global environment.

  • Exceptional ethics and commitment to integrity, social 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 sophisticated 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.

Qualifications Preferred

  • Experience working globally

  • Experience in rare/ultra-rare disease and/or gene therapy

Benefits

  • Medical, Dental and Vision Insurance

  • Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

  • 401(k) match and annual company contribution

  • Company paid life insurance

  • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

  • Long Term Incentive Plan for eligible positions

  • Referral bonus program

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

Category Ethics & Compliance

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

DirectEmployers