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Director/Associate Director, Clinical Data Scientist

Company: BeiGene, Ltd. APAC
Location: Emeryville
Posted on: June 12, 2021

Job Description:

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

The Director/Associate Director, Clinical Data Scientist will support BeiGene Clinical and Medical assets in upholding scientific data integrity and monitoring for patient safety by ensuring successful medical data review (efficient and quality focused medical data planning / specification, collection, review / reconciliation / cleaning, interpretation / analysis, and output / TFL's / narratives). The candidate will report to the global lead medical monitor responsible for their clinical trial(s) for technical deliverable and to the Director, Clinical Development for administration and professional development related objectives.

The candidate will play a key role in the establishment and growth of Clinical Development I/O in collaboration with key functions (i.e. data management, program leadership, biometrics, clinical operations, safety / pharmacovigilance, regulatory, molecular diagnostics, and translational research) to assure best-in-class global capabilities and execution.

This is a newly created role, and as such, the candidate will also participate in medical data management related process improvement initiatives.

Essential Functions of the job:

  • Attend Kick-Off meetings at study start-up and routine or ad hoc medical team meetings, as appropriate.

  • Support the Trial Global Lead Medical Monitor with development and maintenance of data collection forms and instructions (defines medical data capture requirements for data manager / eCCG responsible author in line with protocol and reporting needs) to ensure complete and consistent data recording and reporting by site staff.

  • Support the Trial Global Lead Medical Monitor with the development and maintenance of medical portion of the data review plan for clinical trial(s).

  • Review clinical trial data (identifies patient case anomalies in medical / scientific data by performing Aggregate and/or Subject Level Data Reviews), including, but not limited to:
  • Inclusion and Exclusion Criteria, Medical and Disease Indication History / Treatment, Drug Administration, Adverse and Serious Adverse Event(s), Concomitant Medication(s) and Treatment(s), Study Assessments (i.e. Laboratory Results, ECG's, PRO's, etc.), Efficacy (i.e. RECIST or other Tumor Assessment Criteria for Oncology Trials), and Patient Disposition.

  • Conduct data trend analysis in support of data quality and integrity (includes medical level protocol compliance and unplanned targeted reviews of patient data).
  • Perform data analytics, medical and non-medical, by reviewing reports and visualizations, interpreting data, identifying potential issues of concern, and presenting, as appropriate / requested at internal meetings (i.e. Medical Team Meeting along with possibility of Clinical Study Team and/or Senior Leadership Briefing Meetings).

  • Initiate and manage medical queries to clarify data that requires further investigation with the clinical site to ensure an accurate and comprehensive clinical overview.

  • Summarize, and as necessary, provide training on case level anomalies or database level trends that do not require medical or clinical / scientific expertise, but require data management queries to ensure data entry guideline compliance as well as completeness, clarity, and accuracy of overall dataset.

  • Provide medical, clinical, and scientific advisory expertise to clinical operations and other functional areas to support the successful implementation and execution of clinical studies.
  • May also provide medical, clinical, and scientific advisory expertise to or communicate with external vendors, academicians, collaboration partners, or other entities.

  • Serve as a Subject Matter Expert (SME), as appropriate.

  • Identify continuous process improvement opportunities (continuously looks for opportunities to improve efficiency of tasks and quality of deliverables).

  • Support the Trial Global Lead Medical Monitor with development of output specifications for medical reviews, narratives, and periodic safety update documents.

  • Support for or responsible for medical review and accuracy of narratives within each safety report and reliable medical assessments and comments on individual safety reports, as appropriate.
  • Communicate accumulating safety data internally, as appropriate.

  • Facilitate generation / authorship of, updates to, and/or reviews of documents (provide medical, clinical, and scientific advisory expertise for), including, but not limited to:
  • Protocol concepts, synopses, protocols, and amendments

  • Informed consent documents

  • Investigator Brochures

  • Clinical study reports

  • Support the Trial Global Lead Medical Monitor with protocol deviation or quality driven assessments as appropriate, when requested.
  • Identify root causes of issues and provide medical, clinical, and scientific advisory expertise for remedial actions.

  • Develop, track, execute and report on goals and objectives as appropriate, when requested.

  • Build and maintain strong relationships with internal experts.

  • Accountable for compliant business practices.

Minimum Requirements - Education and Experience:

  • MD, PharmD., Master's or PhD. within a clinical and/or scientific profession (or an equivalent level of professional, clinical and/or scientific education, training, and experience) required.

  • Minimum 7-10 years of professional clinical science experience within biotech / pharmaceutical industry companies or relevant academic institution settings.

  • Previous participation in a clinical development program is essential, including involvement in all stages of clinical trials (i.e. from start up to study report), ideally having taken at least one study through from start to finish in a clinical scientist role.

  • Expert understanding of global clinical study design and drug development process from discovery through registration and post-marketing.

  • Experience in Oncology data review required to fulfill key role (medical data management and clinical data analytics); however, candidates with exceptional experience in other similar therapeutic areas considered if they demonstrate clear potential to apply their existing skills to oncology.

  • Good understanding of clinical / medical data (knowledge of or ability to lookup / research and understand / apply knowledge pertaining to Medical Terminology, Pharmacology, Anatomy, and Physiology).

  • Working knowledge of GCP, ICH, and other relevant regulatory guidelines and standards as they pertain to role.

  • High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills that lend well to working with diverse global colleagues (remote working experience required). Flexibility to work with colleagues across global time zones.

  • Experience with supporting the development of related SOPs and policies.

Capabilities:

  • Executive presence.

  • Values based collaborator - respectful, accountable, and collaborative.

  • Ability to relate to and work with a wide range of people to achieve results.

  • Impactful written and verbal scientific communication.

  • Successful and superior influencing skills across all levels of the organization and external collaborators.

  • Problem solving and risk-mitigation skills.

  • Confident, positive attitude, enthusiastic and charismatic.

  • Appreciation of diversity and multiculturalism.

  • Strategic and creative thinker.

  • Ability to build working relations throughout the organization and with business partners to achieve business goals.

  • Strong time management and organizational skills.

  • Ability to manage multiple projects in a fast-paced environment.

  • Computer skills (see below).

Supervisory Responsibilities:

  • No

Competencies:

Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit. Shares expertise with others.

Adaptability - Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.

Project Management - Communicates changes and progress; Completes projects on time and budget.

Computer Skills: Proficient in Windows Mainframe, Microsoft Office (Word, Excel, PowerPoint, and Outlook), Shared Document and Collaboration Platforms, Data Reporting Platforms (Spotfire Preferred), EDC Systems (Rave Preferred), IRT Systems, Central Laboratory Systems, Safety Reporting Databases / Systems, Quality Systems, and Adobe Software (PDF's).

Travel: Approximately 5 to 10%

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

Keywords: BeiGene, Ltd. APAC, San Francisco , Director/Associate Director, Clinical Data Scientist, Other , Emeryville, California

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