US-MA, Scientific Director, Pharmaceutical Sciences Program Management 1602641-MZ
Scientific Director, Pharmaceutical Sciences Program Management
Expected to engage others by inspiring commitment. Collaborate by influencing through relationships, mobilize high performance, anticipate the group s future needs and help develop capabilities aligned with those needs. Champion change and be a role model for junior staff not only in technical expertise but across Takeda competencies.
Independently leads development of strategy and plans for multiple programs
Regularly leads and influences functional/divisional strategy, operations and innovation
Functional thought leader and mentor
Impactful contributor to divisional initiatives and may contribute to corporate, cross-divisional, and global initiatives
Provides strategic scientific leadership and program management for multiple global CMC development teams dealing with complex development programs that require scientific depth and overall product development acumen for successful execution
Identifies, mitigates and communicates project or program risks to relevant stakeholders. This person is expected to advance not only the program teams they lead but also other teams that are facing unique challenges.
Lead/participates as functional expert in divisional and cross-divisional initiatives.
Represents Pharmaceutical Sciences on cross-divisional governance and development teams while providing strategy and accountability for CMC deliverables. In doing so, accountable for all aspects of program management including budgets, timeline development, risk assessment etc.
Provides scientific leadership and innovation in pharmaceutical research and development. Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives.
Mentors other members of the department to develop their abilities to lead and advance their individual skills of pharmaceutical product development. Demonstrates humility and approachability in encouraging others to challenge ideas and openly raise issues.
Acts as an internal consultant to the Pharmaceutical Sciences staff for any scientific advice that may be needed on a project basis.
Develops 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.
Represents Pharmaceutical Sciences in cross divisional, corporate and global initiatives. Cultivates a broad network of relationships throughout Takeda, with affiliates and alliance partners, in the industry and area of expertise.
Inspires commitment through a wide range of communication channels (meetings, writing, and presentations).
Develops and communicates convincing business cases for department strategies that motivate stakeholders to take action.
Ensures that technical and scientific standards within the function meet state-of-the-art industry expectations.
Identifies, evaluates, develops, recommends and/or negotiates novel solutions to meet critical project needs.
Critically reviews technical and scientific reports from external sources and coordinates Takeda-sponsored work.
Education / Experience
BS + 18 years; MS + 14 years; Pharma D + 13 years; PhD + 12 years
Ability to propose and influence development to result in a commercially viable product.
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. Regularly contributes functional expertise to external industry and advocacy groups.
Must demonstrate knowledge of several allied fields, such as chemical engineering, analytical/organic/physical chemistry, biologics, devices, process engineering, pharmaceutics, quality assurance and/or regulatory affairs. Advanced 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.
Education / Experience:
Program Management Skills/Competencies
Proficient with 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 CMC 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. Represents Pharmaceutical Sciences viewpoint at corporate and industry 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.
Please visit our website at takedajobs.com