Are you looking for a patient-focused company that will inspire
you and support your career? If so, be empowered to take charge of your future
at Takeda. Join us as a Associate Scientific Director, Pharmaceutical Sciences Program Managementin ourCambridgeoffice.
- Leads/represents PS on multiple cross-divisional governance and development teams while providing strategy and accountability for PS deliverables.
- Provides strategic scientific leadership and program management for multiple global PS development teams
- Identifies and communicates project or program risks and provides risk response strategies in a timely manner to appropriate stakeholders and PS management
- Lead/participate as functional expert in divisional and cross-divisional initiatives
- Leads the preparation of the PS sections of global regulatory submissions (e.g. CTAs and commercial applications) and PS responses to regulatory agencies; represents PS at meetings with regulatory agencies, as necessary.
- Manages PS development activities performed by external partners and companies to ensure project deliverables are being met; reviews contracts and invoices as necessary.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education / Experience
BS + 16 years; MS + 12 years; Pharma D + 11 years; PhD + 10 years
- Must have the maturity to utilize scientific and technical knowledge to provide unique business solutions.
- Experience must be in a scientific discipline with expert knowledge of pharmaceutical development, including an understanding of current laboratory techniques, instrumentation, problem solving techniques, process engineering and manufacturing development, and statistics used in experimental work.
- Must demonstrate knowledge of several allied fields such as chemical engineering, analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs. Fundamental understanding in DMPK, Pharmacology and 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 (e.g. Microsoft Project), 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 and cross-divisional goals and objectives; adapts well to varied team dynamics and manages others team members in a respectful manner.
- Risk Management ability to identify/mitigate 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 and functional management; documents issues and/or concerns concisely and comprehensively; adjusts style, language and/or terminology appropriate for the audience. Can represent PS viewpoint at divisional level.
- Resource Management Ability to anticipate and manage internal and external resource needs (people, information, technologies, time, and capital).
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
Requires approximately 10-30 % travel
- PMP certification is preferred
WHAT TAKEDA CAN OFFER
with company match and Annual Retirement Contribution Plan
match of charitable contributions
& Wellness programs including onsite flu shots and health screenings
time off for vacation and the option to purchase additional vacation days
Empowering Our People to
Takeda is an EEO employer of
minorities, women, disabled, protected veterans, and considers qualified
applicants with criminal histories in accordance with applicable laws. For more
information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
No Phone Calls or Recruiters Please.