BeiGene Senior Director, GCO Clinical Program Lead in Boston, Massachusetts
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.
Leveraging deep Therapeutic Area expertise, the Global Program Lead is accountable for the planning, budget, and performance of clinical studies within the responsible program, ensuring they are executed with quality, and according to planned timeline and budget
Essential Functions of the job:
Accountable to the Development Core Team for driving the clinical operations strategy
Evaluate and develop strategic (high level) feasibility, including budget estimates during Early Planning for new CDPs, and during the conduct of a study, where needed
Accountable for resource allocation and initiating CST formation; ensures appropriate transition of outputs from Early Planning to the Global Study Lead
Create and be accountable for annual budget and resource forecasts, as well as CST goals for the program
Create and maintain compound level documents such as IB, ICF, DSUR
Provide guidance to the CST and ensure timely, quality, and efficient study planning and execution of associated clinical programs/studies.
Conduct regular program review meetings to mentor, support, and ensure all studies are tracking to budget and timeline
Report on study status, goals, operational KPIs, and enforce quality KPIs with support from Compliance team
Collaborate with other CPLs to evaluate and designate preferred global vendors and participant in vendor governance meetings
Create and deliver performance and development plans for direct reports
Provide mentorship to Global Study Leads and other junior team members working on the compound
Inspire and lead efforts to deepen scientific knowledge within the Clinical Operations’ function
Champions a global mindset and approach across Clinical Operations to foster collaboration and consistency across the organization
Provide expert knowledge on the execution of clinical trials through deep understanding of ICH/GCP Guidelines and other applicable regulatory requirements
Point of escalation for all compound related issues
Identify and drive process improvement initiatives in collaboration with other Compound Leads
Collaborates with cross functional leaders to provide operational perspectives to enable effective and efficient delivery of clinical development goals
Other duties as assigned
Dotted line management of 5-10 program team members
xxxM USD direct clinical trial budget
Mentor and coach GCO associates.
Education Required: BS, 10 years or MS, 15 years in clinical or drug development in the biotech/ pharmaceutical/CRO industry or the relevant clinical research field. Minimum of 10 years of project management and/or clinical monitoring and/or start-up experience
Computer Skills : Proficiency in MS Office Suite, including Excel, Power Point, and Project.
Other Qualifications :
Fluent in written and verbal English. Desirable: knowledge of Mandarin
Strong project management skills, including ability to work independently, lead multiple projects simultaneously and consistently meet or exceed project deadlines in a fast paced environment
Ability to seek and utilize benchmark data to monitor and champion opportunities to accelerate project timelines without compromising quality
Strong working knowledge of ICH Guidelines, Good Clinical Practices, and Regulatory Agency requirements
Proven ability to make sound judgement and decisions. Possess the ability to quickly assess problems/situations and provide effective resolution/solution.
Excellent interpersonal skills and the ability to build and maintain positive work relationships to effectively interface at all levels across the organization.
Detail-oriented without losing sight of the big picture.
Organized, self-motivated, action and goal-oriented with exceptional follow through.
Travel: As Needed
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 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.
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 – 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, 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.
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