Job DescriptionOBJECTIVES/PURPOSE: - Responsible for developing end to end supply plan for innovative medicines in clinical development. The Sr, Mgr, Planning Lead will attend clinical project meetings to gather relevant information, translating clinical trial protocol information into a study supply plan, forecast study product requirements, interacting and negotiation with key project stakeholders to provide delivery timelines and budget.
- Maintains enterprise view of clinical supply chain connecting CMC, clinical operations, and commercial manufacturing perspectives across the development portfolio.
- Responsible for scenario planning, clinical supply recommendations, and risk mitigation through detailed insight of supply and demand issues for programs of high strategic importance, high cost, and/or under constrained supply.
ACCOUNTABILITIES:- The Senior Manager, Planning Lead will be a primary Interface between clinical supply stakeholders, including Clinical Operations, Pharmaceutical Sciences (PS), GMS, Clinical Supplies operations and Quality Assurance.
- Interfaces with Pharmaceutical Sciences group to ensure that trial supplies are appropriately supported and that appropriate stability programs are in-progress, and/or appropriate expiry dating exists.
- Works closely with Logistics function to pro-actively plan, document, and facilitate global cross-border supply strategies, including requirements associated with controlled substances, compliance to global trade standards, and in-country investigational product regulatory requirements for delivery of product to final destinations.
- Develop Operational Supply Plans for portfolio of development products both internal and acquired through external partnerships. Oversee forecast planning and inventory management of all relevant investigational medicines and comparators for portfolio, leading in matrix of SMEs spanning Takeda supply chain, Takeda pharmaceutical sciences organizations and external partners.
- Lead operational feasibility assessment, scenario analysis and risk mitigation for new clinical protocols, representing the clinical supply chain to global PS teams and global program teams.
- Develop and maintain detailed clinical supply models for complex supply scenarios which provides a study baseline against which to monitor assumptions and inventories of finished goods in ongoing clinical trials.
- Lead establishment of enterprise approach to supply/demand modelling, risk identification, and scenario planning for clinical supply chain, lead cross functional planning teams to respond to unplanned events. Develop supply options, facilitate decision making, and communicate updated manufacturing and supply plans to all impacted stakeholders.
- Responsible for execution of Operational Supply Plan throughout development lifecycle, identifying leading indicators of supply risk and escalating through PS Lead and GPL to course correct.
- Liaise among Clinical Operations, Pharmaceutical Sciences, and Procurement disciplines in planning and managing appropriate levels of CTM and comparator supply in partnership with internal and external stakeholders.
- Utilizes the ClinApps Clinical Supplies Management Database (CSMD) to request packaging/labeling/distribution jobs, to manage inventory, shipments.
CORE ELEMENTS RELATED TO THIS ROLE: - Excellent communication, organizational, and team collaboration skills.
- Must work effectively with global work associates.
- Ability to interact effectively at high levels, between customers and suppliers, and to manage and resolve issues and to provide effective feedback.
- Must be able to handle multiple projects simultaneously while maintaining high quality results.
- Must provide and implement innovative solutions to unique situations.
- Must be able to recognize potential conflict and escalate when necessary.
- Presentation Skills- ability to give professional and concise presentations at internal and external meetings
- Must be aware and compliant to regulations and requirements for functioning under GMP, GDP, and GCP's and Annex 13 and EU CT Directive, and DEA or local controlled-substance regulations as required.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: - Degree in Engineering, Management other scientific/technical degree, Pharmacy, or significant job related experience.
- 6+ years relevant Pharmaceutical Industry and/or Contract Provider experience is preferred.
- Experience with Medical Devices a plus.
- Ability to influence stakeholders from many technical disciplines and at many levels.
- Ability to apply multiple lenses to analyze and represent complex interdependencies, scenarios, and tradeoffs.
- Multiple years of exposure in GxP environment and/or ability to learn key GxP methodology
- Provides input into Interactive Response Technology (IRT) design for randomization, supplying drug to depots and sites.
- Proficiency in computer software applicable to IRT, Excel
- MS Project or equivalent project management software is a plus Sr Manager, Planning Lead
- Drive Process Improvements within Organization
- Ability to influence stakeholders from many technical disciplines and at many levels.
- Ability to apply multiple lenses to analyze and represent complex interdependencies, scenarios, and tradeoffs
Takeda Compensation and Benefits SummaryWe 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:Lexington, MA
U.S. Base Salary Range:$137,000.00 - $215,270.00
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.
For information about our benefits, please click here.
LocationsLexington, MA
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time
Job ExemptYes
