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Job Description

About the role:

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 three 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 a Senior Director, GRA Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team’s success in meeting goals/objectives. Establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team’s success in meeting goals/objectives.

How you will contribute:

• Leads the GRA CMC Pharmaceuticals – Oligonucleotides regulatory team in the development and implementation of global CMC regulatory strategies during development ,commercialization and post approval LCM stages
• Combines knowledge of scientific, regulatory and business issues to ensure the regulatory filings are of high quality and right first time.
• Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations and establishes mechanisms to communicate them to relevant stakeholders, thereby driving prospective and proactive implementation.
• Globally influences and is generally considered a key opinion leader and resource within Takeda and externally with stakeholders in HA and in Industry.
• Influences changing regulations and guidance documents; interfaces with outside regulatory agencies and trade associations and acts as an advisor/liaison to senior management to plan, evaluate and recommend implementation strategy.
• Establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team’s success in meeting goals/objectives.
• ACCOUNTABILITIES
• Responsible for demonstrating Takeda leadership behaviors. Serve as a member of the GRA-CMC Pharmaceuticals Leadership team, giving input to key strategic, portfolio, human capital and financial decisions. 
• Provides leadership of GRA CMC Pharmaceuticals – Oligonucleotides modality, and in conjunction with direct reports, manages resources, establish a CMC RA strategy and collaborate with stakeholders in global Reg CMC and across the enterprise to deliver against them.
• In conjunction with members of the team, develop high quality clinical, commercialization and LCM submissions, using proactive regulatory CMC strategies and submit them as planned.
• Builds and manages relationships through active partnering with key internal (GRA, GRA CMC, Pharmaceutical Sciences, GMS, GQ etc.) and external stakeholders (Health authorities, Industry counterparts/associations, academia). Relationship management and constructive partnering with Health Authorities and relevant industry organizations to drive Takeda position and influence scientific approach and thought process to CMC topics.
• Ensures team effectiveness in working across a very complex matrix environment in GRA with CMC RA project leads and other GRA sub-functions, as needed to ensure effective strategies are developed and project execution is on target.
• Build and maintain communication strategy and platform for all staff across the organization. Responsible for timely dissemination of regulations, guidelines and data to staff and stakeholders via team sites or intranet. Actively engage and influence organization to think proactively and utilize science and risk based approach to product development and LCM activities.
• Contribute to creating and communicating an employment culture and values which attract, retain, and develop the most effective people.
• Ensure compliance with all applicable Takeda SOPs, local and international regulations, and industry best-practice.
• Represents, as required, the regulatory function in the evaluation of new product opportunities internally and externally.
• Leads or plays a key role on the relevant internal Takeda governance
• committees
• Technical/Functional (Line) Expertise
• Comprehensive understanding of the pharmaceutical industry with significant experience in regulatory filings across various stages of development. Ability to simplify and streamline clinical, commercialization and LCM submissions and increase the efficiency of the team through standardization and creation of templates,
• Expert knowledge of API and product development, registration and maintenance regulations with experience in championing innovation in technical areas.
• Experience in operating in a multi-disciplinary drug development environment, including working within and managing across an international exposure.
• Demonstrated track record of successful interactions with FDA, EMA, and other global health authorities to enable informed decision making that are targeted to provide the skeleton from commercialization stage submissions
• Understanding of scientific principles and regulatory requirements relevant to global drug development and regulatory submissions
• Knowledge and understanding of relevant emerging regulations and related processes
• Knowledge of diverse therapeutic areas and recent innovative treatments
• Leadership
• 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.
• Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
• Proven skills as an effective team player who can engender credibility and confidence within and outside the company
• Ability to distil complex issues and ideas down to simple comprehensible terms
• Executive leadership presence and confidence
• Decision-making and Autonomy
• Ability to collaborate with and achieve results through others; builds strong and sustainable relationships and interact within all levels of the organization
• A member of Global CMC RA Pharmaceuticals Leadership team and an extended/ad-hoc member of the GRA CMC leadership team and related councils across the enterprise
• Ad-hoc participation in senior leadership teams as needed
• Responsible for internal processes and systems to support external representation are implemented and effectively working.
• Interaction (The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)
• Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
• Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues.
• Effectively represent Takeda in high-level negotiations with the ability to resolve conflict in a constructive manner
• Ability to build strong partnerships and drive role clarity with other interfacing Takeda functions, including but not limited to GMS, GQ, Pharmaceutical sciences, clinical pharmacology and the therapeutic areas.
• Innovation
• A solid grasp of industry, scientific, and regulatory trends to leverage innovations to make Takeda a model for the industry
• Visionary and forward thinking with the ability to influence and effectively drive organizational change and continuous innovation
• Comfortable challenging the status quo and bringing forward innovative solutions
• Ability to take risks implementing innovative solutions, accelerating time to market
• Complexity
• Ability to work in a global ecosystem (internal and external) with a high degree of complexity
• Ability to manage assignments and effectively deliver all expected deliverables in an organized and a timely manner and proactively communicate changes in pre-established goals and deadlines

Minimum Requirements/Qualifications:

• BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
• 10+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience, with international experience strongly preferred.
• Experience liaising with Regulatory Agencies having served as lead in Agency Interactions and product development meetings, international experience preferred.
• Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
• Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams.
• Ability to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
• Demonstrated leadership, problem-solving ability, flexibility and teamwork.
• Good judgement in elevating and communicating actual or potential issues to line management.
• Excellent written and oral communication skills.
• Experience of active participation in Agency/Industry groups/forums expected.

What Takeda can offer you:

• 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 company match of charitable contributions
• Family Planning Support
• Flexible Work Paths
• Tuition reimbursement

More about us:

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 “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.

Base Salary Range: $194,600 to $278,000 based on candidate 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.

EEO Statement

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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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