Project Manager, CDx Clinical Biomarker Studies

Company: BeiGene
Location: Harrisburg
Posted on: November 21, 2022

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.General Description:The Manager, Biomarker Operations may be responsible for managing biomarker and CDx related operational work for clinical trials.This role will report into the Director, Clinical Biomarker Operations.Key Responsibilities:Manage CDx studies including but not limited to central lab, biomarker testing lab and IVD partners.Collaborate and communicate with IVD partners to make sure IVD activities and timelines meet BeiGene clinical trial needs.Provide oversight to IVD partners to ensure Dx qualityLead three-way (BeiGene, IVD and lab) discussions to align on study activities, like timeline, regulatory submission, etc.Track biomarker samples.Work closely with clinical operations, biomarker scientist and other internal stakeholders to implement biomarker strategyParticipate in regular study team meetings and provide biomarker related updatesCollaborate with DM and programming team and make sure data is transferred as plannedRequired Education:Master or above in biology/medical major.Required Experience:Understanding of CDx processes and regulations Experience in the pharmaceutical or biotech industryUnderstanding scientific concepts and experience in biomarkers and CDx operations.At least 5 years project management experienceProven organizational and project management skills and the ability to manage cross-functional efforts.Ability to work effectively on multiple oncology and CDx programs in a fast-paced, dynamic environmentExcellent communication and negotiation skillsComputer Skills:Skilled in multiple computer-based tools, in addition to software programs such as Word, Project, PowerPoint, Excel, etc.Travel:0 5%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.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.BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. Currently employees are located in APAC, Americas, and Europe. 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, see www.beigene.com.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.At BeiGene, how we work is just as important as the work we do . Below are our Values that determine the decisions we make and how we do things.Patients FirstBold IngenuityCollaborative SpiritDriving Excellence

Keywords: BeiGene, Harrisburg , Project Manager, CDx Clinical Biomarker Studies, Healthcare , Harrisburg, Pennsylvania