Senior Director, Head of RBQM Position Available In Somerset, New Jersey

Job Description:

Join a Legacy of Innovation 125 Years and Counting! DaiichiSankyo Group is dedicated to the creation and supply of innovativepharmaceutical therapies to improve standards of care and addressdiversified, unmet medical needs of people globally by leveragingour world-class science and technology. With more than 125 years ofscientific expertise and a presence in more than 20 countries,Daiichi Sankyo and its 18,000 employees around the world draw upona rich legacy of innovation and a robust pipeline of promising newmedicines to help people. In addition to a strong portfolio ofmedicines for cardiovascular diseases, under the Group’s 2025Vision to become a “Global Pharma Innovator with CompetitiveAdvantage in Oncology,” Daiichi Sankyo is primarily focused onproviding novel therapies in oncology, as well as other researchareas centered around rare diseases and immune disorders.

Summary:

The Senior Director, Head of RBQM (Risk Based Quality Monitoring)sets the vision and strategy for the RBQM function within R D.Reviews and provides guidance to RBQM projects. Accountable for thequality and timeline for all RBQM deliverables. Promotes, overseesand is accountable for innovation, standards, processes andinfrastructure in RBQM. Accountable for selection and oversight ofexternal vendors within technical scope. Will also be responsiblefor the internalization and oversight of the RBQM model.

Collaboration and partnership with other functions and stakeholdersin supporting clinical trial monitoring and execution through RBQMactivities. Accountable for the management, performance, anddevelopment, both technical and career, of direct reports, andmentors or acts as functional manager of skip-level or ex-US staff.

This position requires strong knowledge about RBQM, and relatedprocesses, policies, regulatory requirements and ICH guidance. Thisposition requires excellent project and people management skills,verbal/written skills, analytical, organizational, andinterpersonal skills and works effectively with people at differentlevels and from different disciplines and cultures. Must havetechnical knowledge on integrated data review andderivation/interpretation of metrics that can dynamically interfacewith technical teams in other functions to triage monitoring orother actions with the investigational sites. Additionally, thisposition possesses adequate knowledge of drug development inpharmaceutical industry across different disease areas, and theability to determine risk factors with and for other technicaldepartments (eg, Clinical, Medical, Safety, Data Management,Statistics). This position requires skills in working in afast-paced environment, continuous improvement, change management,and risk management. Experience working and managing CROs in theRBQM space is also required.

Responsibilities:

• Group strategy:

Sets the vision and strategy for the group including overall visionfor a robust risk assessment, mitigation, central (statistical)monitoring and signal detection. Identifies areas to be improvedand initiates rectification or remedial activities. Develops thestrategy for technology and innovation to improve the overallefficiency in project execution and deliverables. Oversees orinitiates RBQM operating procedures and standards; monitors andenforces compliance of standard procedures and processes.

Proactively manages resource planning to ensure adequate resourcesare available to business priorities.•

RBQM Strategy:

Establishesand drives standard RBQM strategy, provides strategic or tacticalinput to the RBQM projects. Communicates and collaborates withother function leaders during this process to support decisionmaking and execution. Develops overall outsourcing strategy for thefunction including internalization strategy and execution plan.

Responsible for developing, implementing, and maintaining the planto internalize RBQM efforts while overseeing the 3-way model forongoing/near term new trials.•

External Vendor Oversight:

Manageshigher-level negotiation with external vendors. Provides oversightof quality/performance and budget, resources and timelines acrossthe department and ensures timely delivery of high-qualitydeliverables at reasonable cost. Provides documented oversight ofthe external vendors/sponsor partnership under the RD-wide vendoroversight structure. Strategically leverages external expertise insupporting RBQM activities.•

Technical:

Provides technicalguidance in Quality by Design. Lead the team to define Critical toQuality factors, select critical variables and processes, and buildappropriate mitigations. Drive interface with Integrated DataReview, Data Surveillance, targeted source document verificationand targeted source data review. Lead the team to develop andimplement metrics including Quality Tolerance Intervals, Key RiskIndicators, Key Performance Indicators, and grouped variables forsignal detection. Articulate to Study Team for appropriate site andstudy level triage, actions, and rectifications.•

Deliverables:

Working with RBQM leaders to provide oversight of activitiesperformed by the internal RBQM function in association with otherDS functions, or any vendor outsourced roles on RBQM behalf.

Advises, directs, prioritizes, and monitors all RBQM activities anddeliverables in terms of timeline and quality.•

People ManagementLeadership:

Accountable for the management, development,recruitment and training of employees within the departmental scopeto meet current and future business needs. Provides exceptionalleadership to employees within responsible areas. Leads coachingand development of employees across the function. Providesleadership by attracting and retaining top talent, developing teammembers, and ensuring organizational effectiveness, transparency,and communication. Manages and provides guidance to team members,including organizing and prioritizing group tasks, performingtraining, and managing performance. Responsible to create anenvironment where employees feel engaged and empowered, and takepride in their roles, responsibilities, and deliverables.

Qualifications:

Successful candidates will be able to meet thequalifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university

• Master’s degree in life sciences, data science, statistics, orrelated field required
• PhD in life sciences, data science,statistics, or related field preferred

Experience Qualifications:

• 11 or more years of experience in RBQM and/or related workexperience in pharmaceutical company, Biotech, or similarenvironment (e.g., CRO). required
• 5 or more years managing peoplerequired
• 5 or more years managing projects required DaiichiSankyo, Inc.

is an equal opportunity/affirmative action employer.

Qualified applicants will receive consideration for employmentwithout regard to sex, gender identity, sexual orientation, race,color, religion, national origin, disability, protected veteranstatus, age, or any other characteristic protected by law.