Associate Director, AD Program Stewardship and Strategy Execution at Takeda

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Job Description

OBJECTIVES:

• Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all local project-related analytical control topics, development requirements and program milestones including global reporting

• Oversight on Analytical Development CAPEX facility builds

• Develop and set vision and direction of departmental activities and infrastructure, including but not limited to establishing and driving line function strategies, program management, resources, and budgets

• Lead and direct the strategy at the interface between portfolio management, project management, and operations. Drive the team's execution and proactively contribute to development strategy and translation of that strategy into action.

• Lead and develop a team of managers and scientists dedicated to training and coaching but also execution of Pipeline program work starting from Research to hand-over to the commercial organization

• Engage with outside organizations and drive collaboration with academic and industry partners.

ACCOUNTABILITIES:

• Responsibility for people and group management. Inspire confidence in team members and lead the organization culture, promoting a healthy and inclusive working environment. Build future leadership while mentoring direct reports and junior employees.

• Organizational leadership of a department and matrix leadership across multiple groups within functional area. Influence on wider cross functional strategy managing internal or external teams (previous managerial experience preferred), accountable for the performance and results of the group. Strategic influence and collaboration across multiple areas/regions within PS and/or external collaborators (people management)

• Contribute to setting the strategy and direction for the overall global function and frequently represents the function within CMC/Pharm Sci and across the global organization. Drives the vision/culture for the operation of the department, and set direction of departmental activities (operational processes) and infrastructure, including but not limited to establishing and driving line function strategies, program management, resources, and budgets (Departmental operations)

• Collaborate with other functions in PharmSci to encourage strategic alignment and successful achievement of shared goals.

• Seamlessly interface with stakeholders, including research development and commercial. Proactively builds relationships with key partners/stakeholders to gain access to understanding to deliver on pipeline goals (Point of contact for PS partners and stakeholders for global processes)

• Identification and application of relevant industry trends to inform operational strategy via oversight of global programs (Global program oversight).Cross functional oversight of high priority projects/programs; accountability for programs within area of responsibility

• Be well versed in all stages of pharmaceutical development and understands the global regulatory trends for CMC activities, to ensure robust and high-quality regulatory filings in all countries active.

• Analyze and synthesize concepts from diverse information –and articulate

• Coordination and assignment of ADRs in collaboration with local heads/leads (Global ADR coordination and assignment)

• Management of mentor assignment, oversight on mentoring activities and ADR training curriculum (Mentoring, training and coaching of ADRs)

• Approve regulatory submission, specification and justification documents (when applicable) (Global program oversight)

• Harmonize internal AD processes between sites and between modalities (Harmonization of internal AD processes for programs)

• Leadership and technical guidance

• Represents Takeda externally and drives external collaboration network strategy

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelors degree and 15+ years relevant industry experience

• Masters and 13+ years relevant industry experience

• PhD and 7+ years relevant industry experience

• Minimum of 7 years of experience working in CMC analytical development area for active pharmaceutical ingredients and drug products under cGMP’s

• Demonstrates effective project management skills

• Teaching and mentoring experience required

• GMP and compliance experience required

• Analytical method development experience required

• Regulatory submission experience required with basic knowledge for regulatory guidelines

• Global cultural awareness, manage inclusively

• Familiarity with working in a global setting (Specific skills required follows)

• Excellent command of English (all sites). German (Austria site)/Japanese (Japan site) is highly preferred (oral and written)

• People managerial experience preferred

• Team player with flexible personality but able to be persistent and assertive

• Highly reliable, self-motivated, responsible and curious personality open to learn and develop and a pronounced desire for improvement

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.

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 job.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-termincentives. 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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time