Senior Director, Pharmaceutical Sciences Portfolio Leader

Job Description

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.

How you will contribute:

• The Senior Director, Pharmaceutical Sciences (PS) Portfolio Leader is accountable for both leading high impact PS programs as an individual, as well as managing & developing a high functioning team of senior PS program leaders that lead a significant portion of the R&D portfolio that consists of multiple modalities over multiple therapeutic areas.
• This role is accountable for delivering Excellence in leadership, Excellence in CMC Strategic Development, and the implementation of playing to win CMC strategies that are in alignment with the Global Project Teams (GPTs) and Therapeutic Area Units (TAUs) strategies/goals/KPIs.
• This role will require the incumbent to drive forward the highest priority R&D programs from development to commercialization that consists of both internally developed and externally acquired assets.
• This role will be accountable for leading the Pharm Sci evaluations of a portion of due diligences of the highest confidentiality and leading / participating in high impact workstreams across the PS / R&D and the commercial organizations.
• The Sr. Director, PS Portfolio Leader is a member of the Pharmaceutical Sciences Program Leadership (PSPL) Senior Leadership Team (SLT) and provides leadership and input into the overall strategic direction of PSPL.
• The role will be accountable for ensuring that stakeholders (including executives) are aligned; that regulatory agencies understand Takeda’s CMC strategies through active participation in key meetings; and that the programs under their portfolio have sound development approaches that have been robustly discussed and agreed upon both within the PS teams / PS leadership and GPTs.

Accountabilities:

• Represents Pharm Sci on GPT and has overall accountability for Pharm Sci input into GPT specific activities for their team member’s portfolio and for implementing/executing the GPT asset strategy into the PS Team development plans.
• Based on a deep understanding of the internal and external CMC environment, ensures alignment of CMC strategies across Therapeutic Area Units (TAU) by providing leadership, coaching and guidance to PS program leaders and their teams.
• Contributes to setting and meeting the goals of the PSPL organization as a senior leadership member.
• Represents PS on other key strategy teams such as the GMS Product team, commercial launch team, R&D wide initiatives and participates in the confidential due diligence assessments.
• Ensures that the technical expertise, leadership and management capability and diversity of their team are in place to meet R&D goals.
• Inspires and develops the members of their team as well as mentoring members across the PSPL / PS / R&D organizations.
• Efficient and timely escalation of urgent issues / risks to the PS Leadership team, GPT, Executives and other stakeholders.
• Ensures that PS wide strategies are considered & implemented into program development plans and PS teams (i.e. digital/China/GEM/knowledge management).
• Creates an environment and culture that inspires confidence, trust and commitment through effective communication and personal actions.

Education & Competencies (Technical and Behavioral):

Education / Experience

• BS + 22 years of experience; MS + 19 years of experience; PhD + 13 years of experience.

Technical Skills/Competencies:

• Experienced leader in drug development of commercially viable product across modality and therapeutic areas.
• Deep knowledge in pharmaceutical development: drug development, process chemistry, biologics, formulation development, analytical development, and/or statistics.
• Has knowledge of several allied fields, such as chemical engineering, analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs.
• Has knowledge of fundamental understanding in Clinical Sciences, Regulatory CMC, DMPK, Pharmacology and Toxicology.
• Has ability to identify gaps in CMC technology/trends and influence change/improvements to affected processes.
• Extensive knowledge of current Good Manufacturing Practices (cGMP), ICH Guidelines, other pertinent national regulations, compendial requirements and communicating with regulatory agencies.
• Demonstrated ability to align, establish and improve business processes across sites to realize business value and simplification. Solid problem solving skills with ability to anticipate problems, recommend and implement solutions that are best for the organization.
• Proven Leadership and People Management skills combined with excellent communication skills and the ability to positively influence colleagues, key decision makers and customers. Proven track record of recruiting and developing high performing team members. Demonstrated ability to work well and manage personnel in a highly cross-functional team environment.
• Experienced People manager able to develop other Program Leaders in drug development and personal career development.
• Must have demonstrated success working and leading projects on a global scale especially with PS personnel and Sr. Management. Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues. Proven ability to proactively identify and lead the development and re-engineering of key processes and systems in support of the business’ mission.
• Excellent interpersonal skills are essential for this role. Ability to effectively influence, build relationships and make recommendations at all levels of the organization.
• Demonstrated thought leadership in previous roles or through relevant university networks or consortia.

General Leadership Skills/Competencies:

• Experience with the application of project leadership knowledge, skills, tools, and techniques for multidisciplinary programs.
• Leadership - develops and uses knowledge and interpersonal skills to influence and guide stakeholders towards the accomplishment of program goals and objectives; adapts well to different personalities and manages others on the team in a respectful manner.
• Risk Management - ability to identify/solve technical, budgetary, and schedule risks to multiple programs and propose appropriate risk response strategies. Ability to identify gaps in CMC technology/trends and influence change/improvements to affected areas/processes.
• Communication - ability to express one’s self clearly and concisely to key stakeholders; documents issues and/or concerns concisely and comprehensively; adjusts style, language and/or terminology appropriate for the audience. Can represent CMC viewpoint within department.
• Resource Management - Ability to anticipate and manage internal and external resource needs (people, information, technologies, time, and capital).

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time