Associate Director, Clinical PV & Medical Quality, CPMQ Global Regions

Associate Director, Clinical PV & Medical Quality, CPMQ Global Regions

As an Associate Director, Clinical PV & Medical Quality, CPMQ Global Regions, you will provide oversight from a clinical research and pharmacovigilance perspective of regulated post-authorization activities in the commercial business units and affiliates. You will drive a fit-for-use global Quality framework that elevates the capabilities in the business units and the affiliate and enables them to deliver their clinical research and pharmacovigilance-related regulated activities with high compliance and agility. You will also establish and maintain relationships with key stakeholders outside R&D such as the commercial Business Units, affiliates. Global Medical, Commercial Quality, etc., supporting post-authorization strategies through thought partnership and linking R&D SMEs and experts, as needed.

Provide expertise clinical research and pharmacovigilance regulations and compliance interpretation, consultation and recommendations to relevant functions in the business units and affiliates.

Ensure that the Global Quality Audit functions consider clinical research and pharmacovigilance regulated activities are considered in their risk-based audit strategy and programs, including supplier audits or internal systems audits. Participate in the audit planning and be a proactive partner in the mitigation of identified risks, ensuring that the risks are communicated and addressed by responsible partners in Global Portfolio Division, R&D and Quality.

Provide expert input in high to medium and/or potential systemic quality investigations in the business units and affiliates particularly in the clinical research and pharmacovigilance areas including cases of serious breach and scientific misconduct. Liaise with the relevant R&D functions and CPMQ personnel, as needed. Escalates issues of potentially critical non-compliance and/or lack of urgency in remediation to Senior Management.

Supports inspections to ensure that any risks are well-communicated within the GPD and Global Quality organizations.

Provides input to Global Quality (Global Audit, Compliance and Commercial Quality) on fit-for-purpose Key Quality Indicators (KQIs) and metrics relevant to clinical research and pharmacovigilance risks that impact marketing authorization holders (MAHs). Analyze and communicate relevant risks within the GPD and Global Quality organizations. Contributes to the relevant quality and compliance governance (e.g., Quality Council) for the business units and affiliates under the GPD.

Ensures that post-authorization and commercial perspectives are analyzed and understood using CPMQ data trends and insights. Communicates relevant trends and insights to stakeholders in Global Portfolio Division and Global Quality.

Drives a fit-for-use global Quality framework that elevates the business units and the affiliate capabilities and enables the affiliates to deliver their clinical research and pharmacovigilance related regulated activities (including evidence generation studies, patient access programs, IIR, collaborative research, RWE/RWD) with high compliance and agility. Champions and drives proactive and innovative approaches and will engage Quality and business leaders for collaboration.

BSc in a scientific or allied health/medical field (or equivalent degree).

Minimum of 10 years of increasing responsibility and relevant experience in the global pharmaceutical industry, with at least 3 years of Quality/Compliance.

Advanced knowledge of clinical research, medical affairs activities and pharmaceutical commercial operations.

Experience must include cross-functional and enterprise collaborations and initiatives, particularly between R&D and Commercial.

Experience working within complex organizations, working closely with senior staff and executive level colleagues.

Excellent communication skills to convey message, whether through public speaking, writing, or interpersonal interactions. Exceptional active listening skills to understand the needs and concerns of others, which is crucial for finding win-win solutions.

Outstanding ability to apply critical thinking and problem-solving abilities to address challenges and advocate for solutions.

Possess outstanding leadership and interpersonal skills with a management style which encourages open expressions of ideas, opinions, and a full discussion of differing points of view. Sound judgment and independent initiative.

Ensures that every employee knows what is expected of their role and what it takes to be successful. Helps employees grow through challenging assignments so they may realize their full potential.

Demonstrated ability to collaborate with and achieve results through others, the ability to build strong and sustainable relationships and the capability to interact within all levels of the organization.

Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues.

Fluency in written and spoken English, additional language skills a plus.

MBA or Quality Assurance (e.g., Lean Six Sigma) certification advantage

Willingness to travel to various meetings, including overnight trips. Some international travel may be required. Requires approximately 10% travel.

Massachusetts - Virtual

$154,400.00 - $242,550.00

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.