Data science manager h1.location_city

General Description:

The Senior Manager - Clinical Science will support BeOne Clinical and Medical assets in the successful execution of clinical development programs and deliverables working in partnership across the organization (clinical development, program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and translational research), with external vendors, and with external academicians and collaboration partners.

The Senior Manager will support clinical program activities and help assure they are executed within expected scope, budget and timelines.

Key Responsibilities:

• Facilitate the generation of, update, and/or review key documents, including, but not limited to:

• Protocol concepts, synopses, protocols, and amendments

• Informed Consent documents; Investigator Brochures; clinical study reports

• Abstracts, posters and manuscripts

• Clinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), Developmental Safety Update Reports, Health Authority briefing documents, Orphan Drug applications, and annual reports

• Risks / benefits analysis for applicable documents

• Assist with clinical development tasks pertaining to study start up, maintenance, and closeout activities

• Partner with Clinical Operations and other functional areas for the successful implementation and execution of clinical studies

• Support Clinical Operations in clinical trial budget planning and management

• Contribute to or perform therapeutic area/indication research and competitor analysis

• Review, query, and analyze clinical trial data

• Interpret, and present clinical trial data both internally and externally

• Provide scientific support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs

• Create clinical study or program-related slide decks for internal and external use

• Develop, track, execute and report on goals and objectives

• Be accountable for compliant business practices

Managerial Responsibilities:

None

Required Competencies

Clinical Development Expertise

• Demonstrates basic knowledge of clinical study design, including familiarity with Phase 1-4 trial activities and standards, and GCP and ICH guidelines

• Able to complete data review and analysis activities

• Able to analyze and interpret scientific literature

Problem Solving

• Analyzes, evaluates, and solves problems accurately in own area of work

• Exhibit good organizational skills with the ability to multitask and prioritize assignments independently to meet deadlines

Communications

• Observes and listens for main points in communications from others, suspends bias and asks clarifying questions and/or summarizes to confirm understanding

• Communicates ideas and intentions in a clear, timely, practical manner

• Ensures that important information is consistently shared with managers, peers and business partners in a timely manner to enable effective decision-making and/or execution

• Selects most appropriate communication method for optimal outcome (e.g. uses phone/in- person vs email)

Teamwork

• Fosters mutually beneficial working relationships

• Demonstrates ability and willingness to actively participate and contribute to group efforts

• Develops and maintains strong working relationships with people across the department and in cross-functional teams

• In a team environment, demonstrates eagerness to support others' efforts

Qualifications:

• PharmD; or PhD within a clinical and/or scientific profession; MD (or equivalent)

• Minimum of 3+ years relevant experience in clinical research and development within the pharmaceutical industry, biotech, CRO or equivalent

Travel:

Approximately 25% of work may involve domestic and/or international travel

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.