Head of Oral Drug Products (Vice President)

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Job Description

OBJECTIVES/PURPOSE:

• Leads the global Oral Drug Product organization and delivery of oral drug product development from early phase through commercialization and lifecycle management.

• Sets strategy and builds capabilities for robust scalable oral formulations and manufacturing processes including tech transfer and process validation/PPQ readiness.

• Partners with PharmSci functions and key stakeholders (GSQ Quality Regulatory CMC Commercial R&D Supply Chain) and external partners to deliver high-quality oral products.

ACCOUNTABILITIES:

• Owns the global Oral Drug Product strategy and operating model to deliver phase-appropriate scalable and robust oral dosage forms across the pipeline and lifecycle.

• Accountable for oral drug product design and development from pre-formulation through clinical and commercial readiness including selection of dosage form excipients and process pathway consistent with target product profile.

• Leads development of robust oral formulations and control strategies using QbD principles including identification of CQAs CPPs design space (where appropriate) and lifecycle management plans.

• Oversees oral process development and scale-up (e.g. blending granulation compression coating encapsulation hot-melt extrusion spray drying 3D/continuous manufacturing where applicable) including tech transfer to internal sites and/or CMOs through PPQ and commercialization.

• Accountable for CMC deliverables for global submissions (IND/CTA/NDA/MAA variations) ensuring high-quality module content responses and inspection readiness for oral drug products.

• Establishes platform approaches and standards for oral dosage forms (e.g. enabling formulations pediatric/geriatric considerations modified release strategies) to increase reuse and reduce cycle time.

• Drives science- and data-based selection and management of CMOs/CDMOs for oral products including governance performance supply risk mitigation and technical oversight.

• Partners effectively with Analytical Drug Substance Device (as needed) Regulatory CMC Quality/GSQ Supply Chain and Commercial to assure robust product and process strategies through launch and beyond.

• Builds a high-performing global organization; develops talent ensures appropriate resourcing across programs and drives a culture of innovation compliance and continuous improvement.

DIMENSIONS AND ASPECTS:

Technical/Functional (Line) Expertise

• Deep expertise in oral solid dose and oral enabling technologies (BCS-driven strategy solubility/permeability enhancement amorphous dispersions salt/co-crystal selection interface lipid-based formulations where appropriate).

• Strong experience in oral pre-formulation and biopharmaceutics-facing formulation design (dissolution supersaturation precipitation risk food effect considerations IVIVC/biorelevant methods alignment).

• Demonstrated capability in oral process development scale-up and manufacturing science (unit operations PAT continuous manufacturing understanding process robustness control strategy).

• Experience with global GMP and oral product regulatory expectations including CMC submission strategy lifecycle management and inspection readiness.

• Proven leadership in tech transfer to internal sites and CMOs including process validation/PPQ execution and commercial troubleshooting.

• Knowledge of packaging/CCS considerations for oral products (e.g. blister vs bottle moisture/oxygen/light protection stability strategy alignment).

Leadership

• Strategic thinking facilitative leadership.

• Executive leadership presence and confidence.

• Enterprise level leadership with the ability to inspire motivate and drive results.

• Excellent communicator able to persuasively convey both ideas and data verbally and in writing.

• Ability to assemble and manage a diverse and high performing team.

• Demonstrated ability to lead teams across functions regions and cultures.

• Ability to distill complex issues and ideas down to simple comprehensibility.

• Proven skills as leader who can engender credibility and confidence within and outside the company.

• Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization.

Decision-making and Autonomy

• Broad decision-making responsibilities:

• Ability to make highly complex decisions that impact the enterprise.

• Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions.

• Ability to incorporate feedback and ensure decisions are made transparently and swiftly to yield flawless execution.

• Accountable for designing and implementing vision and strategy for designated scope.

Interaction

• Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring an engaging and inclusive workplace.

• Ability to effectively implement R&Ds partnership strategy.

• 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 Pharmaceutical Sciences GSQ GPLS and Regulatory CMC.

Innovation

• 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.

EDUCATION BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelors degree in chemistry biology pharmacy engineering or related pharmaceutical science and 25 years relevant industry experience.

• Masters degree in chemistry biology pharmacy engineering or related pharmaceutical science; 20 years relevant industry experience.

• PhD in chemistry biology pharmacy engineering or related pharmaceutical science; 15 years relevant industry experience.

• Demonstrated people and program management skills critical and out-of-the-box thinking ability.

• Demonstrated ability to anticipate issues and manage a team to proactively implement solutions.

• Experience in assuring the implementation of required quality processes and standards to facilitate smooth transition from product development to commercialization.

• Demonstrated expertise in writing regulatory documents.

• Understands the structure functions and methods of the global Takeda organization and overall Takeda R&D and Commercial operations.

• Excellent organizational and communication skills. Has the ability to influence at all levels of the organization and manage projects and initiatives across businesses and the globe.

• Demonstrated ability to negotiate difficult issues and arrive at mutually beneficial solutions.

• Ability to analyze a wide variety of information and data to make management decisions regarding potential risks associated with product quality and regulatory compliance.

• Demonstrated ability to effectively lead and motivate a team of direct reports build on strengths and address areas for improvement.

• Proven record of building mutually-respectful relationships across global regions and companies in order to foster communication and achieve strategic goals.

This position is currently classified as hybrid in accordance with Takedas Hybrid and Remote Work policy.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors including the qualifications of the individual applicant for the position years of relevant experience specific and unique skills level of education attained certifications or other professional licenses held and the location in which the applicant lives and/or from which they will be performing the actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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.

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.

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Job Exempt