Global Clinical Operations (Gco) Strategic Operations Administrator

Beigene, Ltd. Apac Emeryville , CA 94608

Posted 3 weeks ago

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:

Under minimal supervision, provides strategic operational input and support to the VP of GCO and the GCO Strategic Operations Head, as well as senior-level managers as needed. Works in a diverse, international, and complex environment; and includes frequent/continual contact with executive contacts and some contacts with customers. Performs diverse/complex operational and administrative activities including managing projects, composing letters and reports, preparing/editing presentations, and recommending or making purchase decisions, as well as exposure to confidential and sensitive information necessitating considerable use of tact, diplomacy, discretion, and judgment.

Essential Functions of the job:

Provide operational management of the GCO office:

GCO operations:

  • Lead initiatives related to business operations, including establishing best practices and assessing key performance metrics

  • Responsible for tracking and reporting GCO resources, including ensuring up to date job profiles and pathways in place

  • Conduct analysis, as needed, and drive the establishment of strategic goals and prioritization

  • Champion and responsible for GCO communication; draft and distribute across functions within GCO and from GCO to other BeiGene functions

  • Support VP of GCO and Corporate Communications in reviewing and providing comments to press releases

  • Prepare/refine content of Departmental slide presentations; this may include presentations to the EC and Board

  • Design and Lead the coordination of key GCO meetings

  • Townhall (>300 global participants), Leadership forums, Staff meetings; this includes agenda, content overview, preparation, team building activities, minutes, and follow-up actions
  • Ensure successful, well-run LT meetings in partnership with the GCO LT and key stakeholders: drive agenda setting and allocate time appropriately across topics, provide context to agenda topics, and draft agenda/pre-reads and post-meeting minutes; document and track action items

  • Work with GCO LT to establish formal project tracking and operational performance review meetings and reports

  • Maintain and update organizational chart to be inspection ready

  • Support and Participate in FDA inspection readiness for drug approval

GCO Administration:

  • Manage VP of Global Clinical Operations calendar, schedule/arrange meetings, schedule/arrange travel, process expense reports; Support senior-level managers in GCO as needed

  • Independently compose emails/letters and reports on behalf of GCO Office

  • Liaison/partner between functional areas, including clinical science, development, regulatory, medical affairs, manufacturing, commercial, and other functions

  • Recommend or make purchase decisions that would benefit the operations of GCO

  • Responsible for, maintain integrity of the GCO Sharepoint and file documents as necessary

  • Schedule candidate interviews

  • Track out-of-office time, and ensuring GCO is up-to-date with time reporting

  • Maintain confidential and sensitive information

  • Work reliably and with little or no supervision

  • Foster collaboration across the organization

Education Required: BS, in science, business, and at least 7 years' experience in biotech, pharmaceuticals or a related field in the biotech/pharmaceutical industry

Computer Skills : Advanced knowledge of Microsoft Word, Excel, PowerPoint, and Outlook

Other Qualifications :

  • Fluent in written and verbal English. Desirable: knowledge of Mandarin

  • Strong interpersonal skills, leadership, negotiation, analytical and problem solving skills

  • Must be highly multi-tasked and meet compressed timelines

  • Prior experience in Clinical Operations preferred

Travel: As Needed

Location: San Mateo/Emeryville, CA



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


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


  • Listens and asks for 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.


  • 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.


  • 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.


  • 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.


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


  • 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

  • Proactively communicates changes and progress; Completes projects on time and budget.

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.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Director Drug Safety Operations

Planet Pharma

Posted 3 days ago

VIEW JOBS 5/22/2020 12:00:00 AM 2020-08-20T00:00   The Director, Drug Safety Operations will be responsible for creating, directing, and managing the company’s infrastructure and staff to support the operational aspects of the pharmacovigilance system. The role will adhere to all global regulatory requirements and internal processes and procedures. The qualified candidate will have experience in and perform multiple activities related to the overall global safety operations strategy across the portfolio including case management, database strategy, vendor oversight, compliance, inspection readiness, budget, contracts and training. The Director of Safety Operations reports to the VP, Safety and Pharmacovigilance.   ESSENTIAL DUTIES AND RESPONSIBILITIES * Provides strategic planning, implementation, and management of Global Patient Safety (GPS) Pharmacovigilance Operations activities. * Responsible for managing internal and external staff allocated to operational GPS activities, creating a highly efficient team across insourced and outsourced resources. * Provides expert guidance and leadership both internally and externally based on in-depth knowledge of development and post-marketing safety requirements, per ICH; US and international regulations and guidelines; and Good Pharmacovigilance Practice (GPvP). * Builds and implements pharmacovigilance systems fully compliant with the applicable worldwide Health Authority PV regulations. * Ensures that the GPS Database supports the department needs, including specific workflows and reporting/querying functionalities. * Provides oversight of systems and MedDRA updates in collaboration with the relevant vendor(s). * Manages vendors and business partners. Provides vendor oversight and management for all outsourced or insourced PV activities, including establishing and monitoring key quality and compliance metrics. * Develops and implements an inspection readiness program with the contribution of other GPS and non-PV stakeholders. * Responsible for a compliant and quality execution of all operational activities related to case management and related activities. * Oversees timely submissions of expedited reports to the FDA & other health authorities. * Identifies deviations and applicable corrective and preventive actions to maintain the compliance to reporting at its highest level. * Establishes a system for prevention and correction of deviations to compliance with internal and external stakeholders, in collaboration with the Quality group. * Oversees the set-up of new safety projects, including development of study-specific Safety Management Plans and set up of safety systems and database configurations in the PV database to accommodate these trials and products. * Contributes to, drafts and implements department SOPs and work instructions related to the GPS activities. * Oversees signal detection, benefit-risk profile assessment, risk management and aggregate reporting activities with providing accurate reports from the GPS database. * Effectively collaborates with key stakeholders at all levels in the organization. including Clinical Operations, Clinical Development, Regulatory Affairs, Legal, Medical Affairs and Manufacturing to develop compliant procedures in line with industry standards and best practices. * Represents Drug Safety and Pharmacovigilance as a leader on project teams, other departments, and committees as needed * Provide managerial support to one or more employees with overall responsibility of leading, training, and mentoring for effective performance * Other duties as assigned   CORE COMPETENCIES, KNOWLEDGE AND SKILL REQUIREMENTS * Credible knowledge of global regulations governing pharmacovigilance in the pharmaceutical industry and Research & Development processes. * Strong organizational, planning, prioritizing and problem-solving skills. * Effective multi-tasking skills that can be applied in different and complex assignments and ability to work effectively under pressure and under strict timelines. * Ability to work both independently and collaboratively and use own initiative. * Ability to communicate effectively both locally and globally, internally and externally. * Open to changes, suggestions and innovations, continuously on the look-out for work processes' improvements. * Tolerance for ambiguity and ability to adapt quickly to a changing business environment. * Highly resilient, tenacious and resourceful. * Approachable, flexible and self-motivated. * High attention to details. * PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)   REQUIREMENTS * A degree in Life Sciences, with a post graduate specialization in Project or Business Management * 10 years of experience in the pharmaceutical industry, predominately in drug safety/pharmacovigilance operations, having worked on both development and marketed products. * Demonstrated leadership in building safety operations function and experience in vendor management. * Experience of working in a cross functional team and strong project and business management skills. * Experience in managing and supervising team is preferred. * Operational expertise in ARGUS preferred. Planet Pharma Emeryville CA

Global Clinical Operations (Gco) Strategic Operations Administrator

Beigene, Ltd. Apac