Clinical Research Manager, Global Medical Affairs Oncology at Millennium Pharmaceuticals, Inc. in Cambridge, Massachusetts

Job Description:

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Discover more at takedajobs.com.

As a member of Takeda Oncology, your work will contribute to our bold, inspiring vision: We aspire to cure cancer. Here, you’ll build a career grounded in purpose and be empowered to deliver your best.

OBJECTIVES/PURPOSE

The objective and purpose of the Manager (Role 2), GMAO-R, position is as follows:

• Manages the operational life-cycle management (e.g. review, approval and reporting) of GMAO-R programs/projects (which may include one or more programs from medical affairs company sponsored studies, investigator initiated research, collaborative research and name patient program) which may be local, regional or global.  




• Oversees GMAO-R programs/projects globally, regionally and locally, and ensures programs are run in accordance with all applicable internal legal and compliance policies.




• Coordinates with  cross-functional team (internal and external) to ensure alignment with Takeda policies. 




• Directly interfaces and collaborates with internal MA, QA, PV, Regulatory, Legal and IP as it relates to global, regional and local medical affairs programs/projects

ACCOUNTABILITIES

• Manages the operational life-cycle management (e.g. review, approval and reporting) of GMAO-R programs/projects (i.e. which may include one or more programs from MACs, IIR, CCR, NPP) in coordination with local, regional or global stakeholders.   The responsibilities may include but not limited to participatating in the annual budget planningand management cycles, manages drug supplyforecasting, study tracking and archiving, systems development, SOP development, vendor management and training.

• Collaborates with global and regional Pharmacovigilance and Regulatory Affairs leads to respond to internal and/or external audits and requests from external regulatory bodies. Oversees and organizessupport for internal and/or external audits related to the medical affairs  studies/ programs/projects.




• Communicates key program outputs, operational/performance metrics, and accomplishments related to GMAO research.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Basic knowledge of pharmaceutical industry and program management experience.




• Knowledge of the drug development and commercialization process and basic understanding of the functions within the pharmaceutical industry




• Proven ability to communicate clearly and present key information in a concise and objective manner  and




• Interfaces effectively with management and stakeholders external to GMA-R




• Knowledge of regulatory and compliance guidelines governing medical affairs




• Therapeutic area expertise is desirable




• Proficiency with Microsoft Office systems

Leadership

• Project leadership and management skills are required




• Experience building effective networks with internal stakeholders to achieve project goals

Dcision-making and Autonomy

• Ability to predict issues and anticipate risks




• Capacity to independently implement mitigations and drive issue resolution

Interaction

• Flexibility, effectiveness, tolerance and diplomacy to best manage change and differing opinions




• Ability to work in a highly complex, multi-cultural, often stressful environment




• Highly effective communications skills – written and verbal




• Demonstrated ability to clearly and concisely communicate/prepare presentations for management




• Excellent organizational skills




• Effective negotiation and positive influencing abilities

Innovation

• Experience in identifying opportunities for process improvement and takes on, as needed, non-project responsibilities, which can include project management processes and systems

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 

• Bachelor degree with  3 years of research related experience in the healthcare, pharmaceutical or related industry.




• Basic understanding of legal, compliance, and regulatory guidelines related to the conduct of a variety of types of research trials in the pharmaceutical industry.




• ·Experience working in a global organization highly desirable.




• ·Experience working in a matrixed environment highly desirable.

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

Locations

Worker Type

Worker Sub-Type

Time Type

Full time