Executive Director, Head Global Regulatory Project Management and Strategic Planning
- New Jersey - Virtual, New Jersey
- Start date
- Mar 23, 2023
- Administration, Clinical, Clinical Project Management
- Required Education
- Bachelors Degree
- Position Type
- Full time
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as an Executive Director, Head of Global Regulatory Project Management and Strategic Planning where you will be a strategic collaborator and thought partner to the Global Regulatory Affairs (GRA) Therapeutic Area Unit (TAU) Heads. Works closely with TAU Heads to envision new operating models for the execution of TAU operational activities.
You will partner with GRA TAU Heads and Marketing Product Development (MPD) Head to ensure overall alignment on strategies and implementation plans for delivering project management and regulatory operational support to regulatory strategists, global regulatory teams, and submission working groups. Supports GRA TAU and MPD Regulatory Heads by ensuring project management and regulatory operational support is effective, seamless, and delivering to expectations.
You will also drive and lead the Regulatory Project Management and Strategic Planning (RPM&SP) group through the establishment of appropriate governance and best practices. Develops and equips staff and team to enable the delivery of regulatory goals and KPIs. Ensures RPM&SP operational strategies and resourcing meet defined departmental and project objectives and partnership delivery priorities. Generate and deliver actionable portfolio metrics utilizing data and predictive methodologies and proactively identifies opportunities for enhancing processes that optimize the timeliness and quality of deliverables. Identifies and drives submission-related strategic operational and process improvement initiatives, to meet GRA's portfolio/organizational objectives. Define, implement, and maintain a Regulatory Project Management vendor oversight management plan for all outsourced regulatory project management and regulatory operational support activities. Partners with internal stakeholders and outsourcing vendors to ensure all expectations and deliverables are met or exceeded and proactively mitigates risks.
As part of the Regulatory Operations team, you will report to the Head, of Regulatory Operations.How you will contribute:
- Strategic collaborator and thought partner to the Global Regulatory Affairs (GRA) Therapeutic Area Unit (TAU) Heads. Works closely with TAU Heads to envision new operating models for the execution of TAU operational activities.
- Partner with GRA TAU / MPD Heads and GRA Leadership Team (GRALT) to ensure alignment with RPM&SP on execution strategies and implementation plans for delivering project management and regulatory operational support to regulatory strategists, global regulatory teams, and submission working groups. Drives towards harmonization, consistency, and continuous optimization of RPM&SP support model across TAUs / MPD. Delivers support to GRA TAU / MPD Regulatory Heads by ensuring project management and regulatory operational activities are effective, seamless, and delivering to expectations.
- Accountable and oversees RPM&SP organization, processes, tools, and systems ensuring they are effective and continuously improved upon to enable the delivery of expected operational and project/ asset milestones and outcomes. Ensures RPM&SP delivers on each program's submission management and operational goals.
- Provide leadership and direction to ensure RPM&SP group is resourced and has the capabilities to deliver timely and quality end-to-end project management support for submission working groups (SWGs), global regulatory teams (GRTs), and regulatory operational support. Accountable for ensuring that SWGs and GRTs project management support delivers to the expectations of teams, GRA LT, and key stakeholder functional groups. Proactively, and collaboratively identifies areas for improvement and implements solutions. Measures and assess the quality of RPM&SP support and accountability to ensure optimal support is provided to stakeholders.
- Oversee and ensure RPMs develop and maintain integrated regulatory project plans and integrated SWG plans, and that the regulatory development strategy is translated into efficient and realizable operational plans. Ensures that the RPM team's strategies and operational plans align with the project/program objectives and that the RPMs are developed in leadership and operational techniques to add value to the SWGs and GRTs.
- Accountable for ensuring all outsourced regulatory operational deliverables by third parties and vendors meet all program timelines and company standards. Develops and maintains a Regulatory Project Management vendor oversight management plan for all outsourced regulatory project management and regulatory operational support activities. Liaise and proactively engage with third-party stakeholder management to establish and maintain optimum processes for the smooth, effective, and timely execution of operational work lows. Partner with internal stakeholders to ensure all expectations and deliverables are met or exceeded and risks are proactively mitigated.
- Develop and prepare operational performance metrics for RPM&SP deliverables and monitor for early detection of issues and/or opportunities. Utilizes appropriate data and metrics to provide actionable insights to meet or exceed program expectations. Prepare and deliver reports, dashboards, and metrics on major regulatory milestone status, potential critical issues, constraints, bottlenecks, regulatory risks, and mitigation management (and proposed solutions to support decision-making) across all TAU/MPD portfolios, as required. Engages both internal and external stakeholders for solutions and enables timely interventions as appropriate to correct or enhance program outcomes. Develops and maintains cross TAU/MPD Global RPM information and strategic plans/metrics/data (e.g. cycle times, variance analysis) and manages regulatory portfolio status reporting to GRA LT as needed.
- Directly support GRA TAU regulatory heads, and GRA LT with portfolio analytics by creating, leading, and delivering actionable cross-TAU assessment reports, dashboards, and updates, as well as efficient processes for TAU/MPD (individual or joint) portfolio status reviews.
- Drive continuous improvement and consistency across all TAU and MPD GRTs by planning and implementing changes through proactive engagements with GRLs and regulatory TAU/MPD Heads. Identify and propose solutions for addressing potential systemic bottlenecks and constraints, risks, and issues across the portfolio and within and between TAUs/MPD. Ensure all issues are followed through to resolution.
- Actively contribute to the development, implementation, and continuous improvement of PM tools and processes for Global RPM&SP. Maintain lessons learned log across project portfolios; track project variances and identify root causes; detect, raise awareness, and develop a plan to address systemic concerns/issues.
- Provide innovative approaches to enable RPM&SP to efficiently support GRLs, GRTs, SWGs, and GRA leadership. Drive utilization of data, digital, and AI tools to speed and qualitatively enhance RPM&SP processes and deliverables and reduce program risk. Develop novel concepts and approaches to advance and/or continuously challenge existing paradigms.
- Partner with the GRLs and GRA LT to ensure Global Product Teams (GPT) regulatory goals are cascaded and that the Global Regulatory Strategy Plan is operationalized and executed across all TAUs/MPD. Ensure seamless alignment of operational plans with Global Project Management (GPM) and Therapeutic Area Units (TAUs)/Business Units (BUs) asset strategies.
- Drive decision-making processes and escalate issues, as needed, ensuring proactive planning is taking place to enable the delivery of all regulatory milestones across all TAUs and MPD portfolio of projects. Ensure teams are utilizing best practices to manage program timelines and in projecting and communicating resource requirements and gaps such that there is no compromise to regulatory objectives and goals.
- Elevate high-impact business critical issues and potential critical issues together with a proposed plan of action, as appropriate, in a timely manner to management.
- Consult, support, advise, and contribute to Takeda’s body of Regulatory Project Management Knowledge and Project Management processes.
- Supervise, coach, and mentor staff. Provide leadership and training to support all members of the Regulatory Project Management and Strategic Planning team to enable their delivery of all expectations and their professional career development.
- Bachelor in science required. Advanced degree preferred.
- 12 years of pharmaceutical experience with 8 years regulatory or 10 years related field preferred.
- Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology, and processes is required.
- Understanding of scientific principles and regulatory standards/requirements relevant to global drug development and post-market support.
- PMP certification or equivalent.
- Additional certification a plus: Regulatory (e.g. RAC or equivalent), Change Management.
- Demonstrated expert experience leading high-performance teams, managing staff, and mentoring colleagues.
- Proven ability to provide regulatory operational support and guidance.
- Able to deal with issues of critical importance provides regulatory operational advice and makes reasoned decisions on regulatory operational issues.
- Demonstrates leadership, problem-solving ability, flexibility, and teamwork.
- Exercises good judgment in elevating and communicating actual or potential issues to line management.
- Active participation in Industry groups/forums is expected. Recognized as an expert in the field.
- Excellent verbal and written communication skills and ability to prepare effective presentations with focused messaging
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs and a company match of charitable contributions
- Family Planning Support
- Flexible Work Paths
- Tuition reimbursement
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.
Base Salary Range: $ 194,600 - $278,000, based on the candidate's professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program, and Paid Volunteer Time Off.
The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
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.LocationsNew Jersey - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.
For more information, visit https://www.takeda.com.
Stock Symbol: TAK
650 East Kendall Street
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