At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
As an Associate Scientific Director working on Pharm Sci teams (PS-Team), you will be empowered to be a key player in the Pharmaceutical Sciences division of Takeda and work to develop solutions for Takeda's critical project needs.
Expected to engage others by inspiring commitment through leadership and clarity of vision. Lead by influencing through relationships, mobilize high performance through targeted development, anticipate the team’s future needs and help lead the PS-Team activities with those needs. Also contribute to Global Project Team (GPT) activities as Pharm Sci representative in defining and executing GPT strategy toward successful product launch and product value maximization through agreed LCM activities.
- As PS-Lead for PS-Team, ensuring advancement and transparency for programs to GPT Lead (GPL), PS management and other key stakeholders.
- Develop and execute CMC development plan with other PS-Team members
- Manages day to day operations and risks/issues associated with assigned program
- Leads and influences Functional and Divisional initiatives and contributes to corporate/global initiatives.
- Exemplifies and is recognized for expertise in, and contributions to, Functional and Divisional team leadership and communication.
- Leads multifunctional team in a metrics environment and effectively influence the performance of team members without authority
- Manages and oversees the timely communication and transparency of PS-Team activity to GPL, PS management and other key stakeholders
- Identifies, mitigates and communicates program risks to relevant stakeholders.
- Represents PS on GPT while providing strategy and accountability for PS deliverables. In doing so, accountable for all aspects of program management including budgets, timeline development, risk assessment etc.
- Cultivates a broad network of relationships throughout Takeda, with affiliates and alliance partners, to advance and promote understanding of PS mission/job purpose and capability.
- Leads/participates as functional expert in divisional and cross-divisional initiatives.
- Identifies, evaluates, develops, recommends and/or negotiates novel solutions to meet assigned program needs.
- Demonstrates humility and approachability in encouraging others to challenge ideas and openly raise issues.
- Lead/contribute to enhance individual skills of pharmaceutical product development.
- Lead/contribute in developing the capabilities of the department by identifying opportunities and anticipating changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business and proposing innovative solutions to address them.
- Inspires commitment through a wide range of communication channels (meetings, writing, and presentations).
- Collaborate with other members in the department to ensures that operational standards and practices within the function meet state-of-the-art industry expectations.
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BS + 15 years of experience, or MS + 12 years of experience, or PhD + 10 years of experience
- Ability to propose and influence development that results in a commercially viable product.
- Must have the maturity to utilize scientific and technical knowledge to provide unique business solutions.
- Must be well-experienced in the development of biologics (additional small molecules development experience is a plus)
- Experience must be in a scientific discipline with expert knowledge across the full spectrum of PS related pharmaceutical development.
- Must demonstrate knowledge of several allied fields, such as biologics, chemistry, process engineering, pharmaceutics, quality assurance, DMPK, Pharmacology and/or Toxicology.
- Extensive knowledge of current Good Manufacturing Practices (cGMP), ICH Guidelines, other pertinent national regulations, compendial requirements and communicating with regulatory agencies.
- Must have experience in global regulatory submission requirements and processes
Program Management Skills/Competencies:
- Proficient in the application of project management knowledge, skills, tools, and techniques for complex multidisciplinary programs and initiatives.
- Leadership - develops and uses knowledge and interpersonal skills to influence and guide internal and external stakeholders towards the accomplishment of program, divisional and corporate 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 PS technology/trends and influence change/improvements to affected areas/processes.
- Communication - ability to expresses 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 PS viewpoint at corporate and industry level.
- Resource Management - Ability to anticipate and manage internal and external resource needs (people, information, technologies, time, and capital).