Director, Clinical Operations

Beigene, Ltd. San Mateo , CA 94401

Posted 3 weeks ago

Company Overview:

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 2,200 employees in China, the United States (Cambridge, MA; Ridgefield Park, NJ; Emeryville, CA & San Mateo, CA), Switzerland and Australia, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients. For more information, please visit www.beigene.com.

Position Summary:

  • Leads a therapeutic area (TA) within Clinical Operations with responsibility for line management, strategic planning and alignment with broader organizational goals

  • Applies deep knowledge of therapeutic area to provide expert input and guidance on programs for appropriate, feasible and effective clinical trials design and execution for specific disease areas / patient populations

  • Establishes reputation and capability for successful delivery of clinical trials, in partnership with CROs

  • Develops direct and indirect reports (e.g., Clinical Project Managers) to ensure greater value is added to the business across all areas

  • Has a passion for and leads efforts to deepen Clinical Operations' knowledge of science in order to drive faster, high quality clinical trial

Essential Functions of the job:

  • Develops training plans and programs across Clinical Operations to enhance project management skills

  • Contributes to and has accountability for overall Clinical Operations strategy and performance against key metrics

  • Conducts strategic planning for TA programs to ensure clinical studies meet overall goals for TA

  • Ensures that multiple, novel ideas on how to deliver on clinical trials are generated and considered

  • Leads Associate Directors and Project Managers, including mentoring, coaching and managing performance

  • Actively oversees the knowledge management process by ensuring information is captured, retained, and leveraged in future work

  • Ensures operational processes, systems and standards are adopted and implemented consistently across trials

  • Contributes to Clinical Operations and clinical trial sourcing strategy development and takes a lead role in vendor governance

  • Delegates, but oversees, the resourcing process and ensures ADs are staffing CTAs and Sr. CTAs so that they are getting opportunities / access to different clinical trials and broadening / getting appropriate developmental experiences for where they are in their careers

  • Champions a global mindset and approach across Clinical Operations to foster increased collaboration and consistency across BeiGene

  • Ensures alignment with broader BeiGene strategic initiatives and business needs and provides recommendations or ideas on how Clinical Operations' programs can generate greater value for BeiGene overall

  • Ensures there is advocacy / voice of the patient represented in the planning, design and conduct of clinical trials

  • Partners within and beyond Development to leverage Business Development, clinical and scientific expertise & insight across BeiGene

  • Ensures Clinical Operations TA thinking and activities are aligned with overall business direction and priorities

  • Identifies opportunities and initiatives within the broader Development organization that can be adopted / adapted by Clinical Operations as a best practice; equally recommends best practices within Clinical Operations that if more broadly applied would benefit BeiGene's Development organization as a whole

Requirements:

BS, or Master's Degree preferred in a scientific or healthcare discipline, 7-10 years in clinical and drug development in the

biotech/pharmaceutical industry.

Computer Skills:
Efficient in Microsoft Word, Excel, MS PowerPoint and Outlook

Other Qualifications:
Strong written and verbal communication skills

Travel: Up to 30% globally

Supervisory Responsibilities:

Delegates, but oversees, Associate Directors, Managers, Sr Managers of Clinical Operations, CTAs and Sr. CTAs so that they are getting opportunities / access to different clinical trials and broadening /getting appropriate developmental experiences for where they are in their careers.

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.
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Director, Clinical Operations

Beigene, Ltd.