Takeda Pharmaceutical Boston MA United States
5 days ago
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 an Associate Director/Director, Clinical Data Management, Quantitative Clinical Pharmacology in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director/Director, Clinical Data Management, Quantitative Clinical Pharmacology working on the team, you will be empowered to manage strategic, scientific and operational aspects of multiple drug development programs from the clinical pharmacology perspective, and a typical day will include:
The position is responsible to support the Pharmacometrics Head (PML) or Quantitative Clinical Pharmacology Leader (QCP-L) who is the modeling lead in development and execution of PK/PD Modeling and Simulation activities related to the research, design, implementation, data analysis, interpretation, reporting, and publication of QCP sponsored and -supported studies for products in any phase of development. The PM support team is mainly passionate about data related and e-submission related aspects.
• Prepare programming scripts (e.g. R, SAS) to generate NONMEM analysis input dataset(s) for PK and/or PD analysis. During dataset generation, modifies the variable definition file which clearly defines each variable within this dataset with any additional information as they see fit. The NONMEM input dataset(s) created could be for interim or final analysis. The source used could be interim (uncleaned) or final SDTM/ADAM datasets or in sources in other formats, in some cases extensive data cleaning and complex calculation are needed.
• Upon request, QC NONMEM input dataset(s) generated by another PM support colleague. Log which QC script is used, which subjects were checked per study, what other aspects were checked within the dataset, the findings of the QC and the follow-up actions of those findings in a QC document.
• Generate e-submission package for NONMEM (or other modelling type) analysis. In general, the package includes NONMEM input datasets, NONMEM control file, output parameter files, output table files and other files, in addition to supporting documents such as define and var-names-descr files. PM support renames the files provided by PM leader or CPP leader so they fit the naming convention requirements for e-submission package if needed, converts these files into the appropriate formats, and places them into the right folder structure then links them to the define and var-names-descr files. PM support works closely with EPOD team to ensure the e-submission package has the right structure, accurate formats and being placed in the right assembly server directory.
• Interact with other departments (including but not limited to Data Management, Programming) and external Vendors to communicate the needs of QCP in data collection, data formatting, data representation and cross departmental trainings if needed. Promote better understanding across different departments.
• Improve QCP internal processes in dataset creation, dataset QC (e.g. a standard QC R script with a checklist) and e-submission package preparation (e.g. R script which can automate the linking of documents).
• Experience with data plotting in R is desired (e.g. ggplot2).
• Carry out functional responsibilities in accordance with applicable SOPs and Regulatory requirements
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
• B.S. Degree or equivalent with 3 to 5 years of experience in pharmaceutical industry or M.S. Degree with 1-2 years of experience in pharmaceutical industry.
• Expertise in one of the programming languages which are commonly used in data assembly community (e.g. R and/or SAS).
• Data-handling skills and solid understanding of clinical database structures such as SDTM and ADAM
• Knowledge of principles of non-linear mixed effect modelling
• A fundamental understanding of clinical drug development and PK & PK/PD population PK modeling concepts
• Good written and oral communication skills
• Ability to build and improve working relationships inside and outside the department; ability and willingness to work in a cross-functional team environment (building strategic working relationships)
• Ability to multi-task and prioritize assignments, establishing courses of action for self and others to ensure that work is completed efficiently in a timely manner (planning and organizing)
• Attention to detail
• Contributing to the organization assuming responsibility and accountability for successfully completing assignments or tasks (delivery of results)
• Actively identifying new areas for learning and application to the job (continuous learning)
• Good sense of cultural sensitivity and diversity (cultural diversity)
• Self-motivated with the ability to work independently with minimal direction (personal accountability)
• Estimated travel of about 5% of time
Location and Salary Information:
This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.
Base Salary Range: $143,500 to $205,000 based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
WHAT TAKEDA CAN OFFER YOU:
• 401(k) with company match and Annual Retirement Contribution Plan
• Tuition reimbursement
• Company match of charitable contributions
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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