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.
The Director, Clinical Operations leads a therapeutic area (TA) within Clinical Operations with responsibility for line management, strategic planning and alignment with broader organizational goals. The Director 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 Study 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 trials.
Essential Functions of the job:
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Develops training plans and programs across Clinical Operations to enhance project management skills
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Contributes to and has accountability for overall Clinical Operations strategy and performance against key metrics
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Conducts strategic planning for TA programs to ensure clinical studies meet overall goals for TA
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Ensures that multiple, novel ideas on how to deliver on clinical trials are generated and considered
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Leads Associate Directors and Project Managers, including mentoring, coaching and managing performance
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Actively oversees the knowledge management process by ensuring information is captured, retained, and leveraged in future work
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Ensures operational processes, systems and standards are adopted and implemented consistently across trials
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Contributes to Clinical Operations and clinical trial sourcing strategy development and takes a lead role in vendor governance
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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
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Champions a global mindset and approach across Clinical Operations to foster increased collaboration and consistency across BeiGene
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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
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Ensures there is advocacy / voice of the patient represented in the planning, design and conduct of clinical trials
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Partners within and beyond Development to leverage Business Development, clinical and scientific expertise & insight across BeiGene
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Ensures Clinical Operations TA thinking and activities are aligned with overall business direction and priorities
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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
Supervisory Responsibilities:
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Delegates and oversees Associate Directors, Managers, Sr Managers, CTAs and Sr. CTAs ensuring the team is given opportunities to work on diverse trials and broadening and expanding skills and capabilities for both the benefit of BeiGene and their careers
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Ensures the competencies and skills required for the Clinical team is consistent with the company defined requirements
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Mentor junior team members to support development by delegating responsibilities, overseeing and supporting development plans
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Conduct mid-year and year end performance appraisals for direct reports which includes providing constructive feedback
Other Qualifications:
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10+ years progressive experience in clinical operations preferably within the biotech, pharmaceutical, and/or CRO environment
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5+ years proven leadership experience managing direct reports in a fast paced, matrix environment and operating at the clinical development plan level, as well experience in mentoring and influencing junior-level staff
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Possess understanding of treatment landscape, standard of care, upcoming approvals, and good knowledge of KOLs and investigators
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Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required Demonstrates a strong understanding of methodologies and approaches
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Experience developing trial plans including site monitoring, pharmacy and lab manuals, risk mitigation strategies, trial budgets and site selection/feasibility as required
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Proficient written and verbal communication skills
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Proven experience collaborating effectively with the study team, cross functional team members and external partners (including investigator and site staff) using effective negotiation skills
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Management experience of CROs, Vendors and Consultants preferred
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Therapeutic or medical knowledge preferred
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Regulatory authority inspection experience a plus
Computer Skills:
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Efficient in Microsoft Word, Excel, MS PowerPoint and Outlook
Travel:
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Up to 30% globally
Education Required:
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Bachelor’s degree in a scientific or healthcare discipline required; Masters degree preferred
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.
Salary Range: $158,700.00 - $218,700.00 annually
BeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
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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