Senior Research Manager, US Medical

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Job Description

The objective and purpose of the Senior Manager, US Medical Clinical Research, RPE position is as follows:

• Partner with Director, Research Process Excellence, RPE to support process for US Medical Research studies, including Medical Company Sponsored Studies (MACS), Collaborative Studies and Investigator Initiated and Sponsored Research (IIR) studies for multiple therapeutic areas and product programs. Manage study budgets and communicate study activities to team members.
• Responsible for the process to help conduct MACS, Collaborative and IISR studies as applicable within assigned TA observing all applicable internal legal and compliance policies and external regional and country specific regulatory guidelines.
• Support assigned therapeutic area when working and collaborating with team members (e.g. GMA Region and LOC medical leads, TA Medical Heads, alliance partners, etc) and external investigators to develop US Medical clinical research plans and budgets.

May lead special projects according to US Medical our needs (e.g. external engagement's, process optimizations).

ACCOUNTABILITIES

• Support the process of the annual US Medical Research strategy for assigned therapeutic areas in collaboration with US Medical Research Leadership, Therapeutic Area Medical Directors, Scientific Directors, Clinical Science Lead, as applicable, and oversee allocation of the research budget.

MACS Studies:

• Manage receipt, processing and meetings required for study concept and protocol submissions. Provide final approval for research committee materials including study concepts and protocols, meeting minutes, and team communications.
• Manage operations of the internal CTMSVeeva for studies per Medical SOPs and processes and propose process improvement.
• Support implementation of all Clinical Study Manager and external resource activities to ensure Company Sponsored studies are conducted in GCP compliant and quality manner following all company processes and applicable laws.
• Support Study Execution Team to lead Company Sponsored Studies forward to achieve objectives within target timelines and budget.
• Support study contracts and finances including budget forecasting, contract execution and management, change order processes and improvement, invoicing and accruals.
• Participate in SOP development to ensure US Medical has current processes relevant to current work and future developments.
• Responsible for the tracking and communication of important outputs, performance metrics, and accomplishments related to US Medical external research studies within assigned TA.
• Communicate with important team members (including US Medical Therapeutic Area Medical Directors, Scientific Associate Directors, Liaisons, external investigators) to resolve and discover cause for study related issues. Support the efficient and compliant functioning of the US Medical Clinical Research program within assigned therapeutic area.

Collaborative Studies:

• Manage receipt, processing and meetings required for study concept/synopsis, protocol development and submissions. Provide final approval for research committee materials including study concepts and protocols, meeting minutes, and team communications.
• Support processes for studies per Medical SOPs and applicable laws and propose process improvement.
• Support medical and research team to lead research forward to achieve objectives within target timelines and budget.
• Manage collaborative study contracts and finances including budget forecasting, contract execution & management, change order processes and influence, invoicing and accruals.
• Conduct fair-market value (FMV) assessments of approved studies for assigned therapeutic area observing Takeda procedures using experience from past studies.

IIR Studies:

• Support processing of study submissions by Medical staff or external investigators. Review and work with Medical Research leadership to approve research committee materials including study concepts and protocols, meeting minutes, and investigator communications ensuring they are scientifically sound and accurate.
• Facilitate TA research committee meetings used to approve, and track studies, as applicable.
• Coordinate the capture, archiving and reporting of study level information (including patient safety information) from US Medical IISR clinical trials in assigned TA. Ensure coordination with Pharmacovigilance and Regulatory Affairs to respond to external audits and requests from external regulatory bodies.
• Conduct fair-market value (FMV) assessments of approved studies for assigned therapeutic area following Takeda procedures using experience from past studies.
• Support, IISR program budget including budget tracking, forecasting, contracting and invoicing.

DIMENSIONS AND ASPECTS

Technical/Functional Expertise

• Understanding of the pharmaceutical industry and regulations governing medical functions within industry activities and medical regulatory process, including Clinical research, study design, and good clinical practice.
• Clinical Research and program management experience working with clinical programs within Medical Affairs, Clinical Research, Regulatory, CMC or other drug development related function.
• Experience managing study budgets.
• Applied knowledge of performance management (e.g., metrics, dashboards)

Decision-making and Autonomy

• Predict issues, anticipate risks and solve problems
• Ability to articulate and establish processes to foster cross-functional efficiency or resource scalability

Interaction

• Flexibility, tolerance and diplomacy to best manage change and differing opinions
• Work in a complex, multi-cultural, often stressful environment
• Highly effective communications skills – written and verbal
• Demonstrated ability to concisely communicate/prepare presentations for management
• Excellent organizational skills
• Negotiation and positive influencing abilities
• Proven ability to work effectively and diplomatically in conflict situations

Innovation

• Experience identifying and supporting opportunities for process imporovement and takes on non-project responsibilities, which can include project management to implement new processes.

Complexity

• Manage multiple tasks of varied complexity to allow delivery of multiple and complex projects within a single or across therapeutic areas for US Medical.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

Required:

• Bachelor's degree required in a health sciences related field with 5+ years healthcare or pharmaceutical industry experience and 3+ years of clinical research, study management and clinical project management.
• Demonstrated understanding of the legal and regulatory guidelines associated with pharmaceutical industry research and external granting functions and the ability to use knowledge to make sound operational decisions.
• Communicate with a variety of clients both internal and external to Takeda.
• Experience with finance principles and their use in managing study budgets.

Desired:

• Masters Degree in a health related field.
• Experience collaborating and indirectly managing other individuals with a variety of scientific and non-scientific backgrounds and training.

Leadership Skills & Behaviors:

• Matrix project leadership required.
• Strategic problem-solving ability and identify appropriate solutions.
• Solid influencing skills and ability to negotiate in a matrix environment to improve development and address barriers.
• Highly effective written and verbal communication skills, including strong presentation skills.
• Ability to execute business process transformation and implement organizational culture change.
• Manage multiple tasks of varied complexity.
• Flexibility, tolerance and diplomacy to best manage change and differing opinions.
• Excellent organizational skills.
• Proven skills in negotiation, influencing without authority, managing through ambiguity, and working diplomatically through conflict.
• Knowledge of all MS Office tools to capture and communicate project information
• Fluent in English.

ADDITIONAL INFORMATION

• Must be able to work at computer for several hours at a time.
• May travel ~10% of time, within US with occasional international travel.

Takeda Compensation and Benefits Summary

We 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

EEO Statement

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.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

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