Associate Director Post Trial Supply/Patient Programs

General Description:

The Clinical Operations Excellence Organization is a sub-function under Global Clinical Operations responsible for driving and monitoring compliance, performance metrics, process improvements (processes

and procedures), Training, Risk Based Monitoring and Patient Support Programs. This role will focus on providing Post Trial Supply Access to patients exiting a Sponsor parent protocol who are eligible for continued patient access to Sponsor medicines thru the Patient Programs/PTS route. This is a global role that will work cross functionally within Sponsor to ensure adherence to the PTS process.

Patient Support Programs (“Post-Trial Supply”):

·       Lead or co-lead the Post-Trial Supply activities across Global Clinical Operations Trial portfolios/compounds as needed/established

·       This will include following and/or establishing new or revised GCO policies and procedures for PTS SOP.

·       Working with the PTS Director- ensure cross functional team members are provided with appropriate vision, direction, training, and support to ensure PTS access as needed and where regulatorily allowed by region/country.

·       Support the PTS Director to maintain Post-Trial Supply Governance Board aimed at driving PTS access across our portfolio, countries, and regions as needed.

·       As the PTS Lead- partner with key stakeholders and external partner vendors in ensuring proper execution of PTS access programs and solutions are aligned with country level regulations.

·       Support and collaborate with the PTS Director to develop, establish, and report post-trial supply related metrics (KPIs/KQIs), tools and training materials for optimal change management within BeiGene organization.

·       Support and co-lead the Identification of emerging regional/country/ regulatory risks or concerns related to the roll-out and execution of Post-Trial Supply programs.

·       Will need to be trained and have access to Sponsor CTMS to review upcoming and ongoing portfolio/compound activity for PTS forecasting needs.

Supervisory Responsibilities:  

·       None

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.

Computer Skills:   Microsoft Office Suite, Excel, PowerPoint, Word, etc. DocuSign

Other Qualifications:   Ability to multitask, Critical thinking, ability to work in a matrix environment

Travel: minimal to none except if department wide face to face is needed.