Director/Associate Director, Clinical Data Scientist
Company: BeiGene, Ltd. APAC
Posted on: June 12, 2021
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.
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
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
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
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
Communicate accumulating safety data internally, as
- 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
Clinical study reports
- Support the Trial Global Lead Medical Monitor with protocol
deviation or quality driven assessments as appropriate, when
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
- 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)
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
Expert understanding of global clinical study design and drug
development process from discovery through registration and
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
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
Values based collaborator - respectful, accountable, and
Ability to relate to and work with a wide range of people to
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
- Computer skills (see below).
Ethics - Treats people with respect; Inspires the trust of
others; Works with integrity and ethically; Upholds organizational
Planning/Organizing - Prioritizes and plans work activities;
Uses time efficiently. Completes administrative tasks correctly and
on time. Follows instructions and responds to management
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
Technical Skills - Assesses own strengths and development areas;
Pursues training and opportunities for growth; Strives to
continuously build knowledge and skills; Shares expertise with
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
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
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
Keywords: BeiGene, Ltd. APAC, San Francisco , Director/Associate Director, Clinical Data Scientist, Other , Emeryville, California
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