Associate Medical Director (MD), Biotech Unit

10 Jun 2024

Vacancy expired!

Company Overview:BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) is a global, commercial-stage, research-based biotechnology company focused on molecular-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, please visit www.beigene.com.General DescriptionReporting to the Clinical Development Lead, Biotech Unit (BU), the position is a member of BU and contributes to clinical development strategy and supports successful execution of clinical development programs in BU. Leveraging deep therapeutic and functional area expertise, the Senior Physicion/Associate Medical Director/Medical Director will be accountable to jointly develop clinical program strategy and help assure that activities are executed within expected scope, budget and timelines. The incumbent will work closely with colleagues in clinical development, program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and translational research to ensure successful deliveries by Execution Unit.Roles & Responsibilities:Jointly develop clinical development strategy and clinical development plan that meet worldwide regulatory and commercial/access needs for BTU assetsPartner with core team members in Execution Units for the successful implementation and execution of clinical studiesSupport to provide scientific expertise for selection of investigator and vendorsSupport to provide scientific and medical guidance/support throughout conduct of a clinical trialReview, query, and analyze clinical trial dataInterpret, and present clinical trial data both internally and externallyBuild and maintain opinion leader/investigator networks; support organization and presentation at key opinion leader advisory boards and investigator meetingsFacilitate generation of, author, update, and/or review key documents, including, but not limited to protocol concepts, synopses, protocols, and amendments, informed consent documents, Investigator Brochures, Clinical study reports, abstracts, posters and manuscripts, as well as clinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports, Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports, risks / benefits analysis for applicable documents, Clinical Development Plans etc.Provide responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, investigators, and CROs etc.Consult with Advisory Committee for relevant topics and incorporate the ideas into strategy and execution if appropriateProvide guidance/training to function team in Execution Unit, CRO staff and study site staff on the therapeutical area, molecule, and/or clinical protocol and may provide coach and mentorship to the team members working on the assets when there’s performance concern and for team development purposeConduct regular review meetings with Execution Units with Biotech Unit core-team to support, and ensure all studies are tracking to quality and timelineReport on study status, goals, operational KPIs, and enforce quality KPIsChampions a global mindset and approach across Global Development to foster collaboration and consistency across the organizationContribute to or perform therapeutic area/indication research and competitor analysisParticipate company-wise standard discussion, finalization, and implementationOther duties as assignedEducation/Experience Required:MD, DO degree or equivalent degree in related discipline requiredQualifications/Requirements:Basic requirements and experience:MD, DO degree or equivalent degree in related discipline required, with 4 plus years relevant work experience including 3 plus years in oncology therapeutic area, is requiredProfessional knowledge and skills working in oncology therapeutics is requiredWorking knowledge of applicable International Compliance guidelines and regulations is expectedExperience working in global environment is requiredExperience with the development and support of related SOP's and policies is expectedExperience with partnerships ad strategic alliances is expectedDeep knowledge of and direct clinical development experience in oncology drug development is required. Deep understanding of immune-oncology strongly desired.Fluent in written and verbal English. Desirable: knowledge of MandarinDetail-oriented without losing sight of the big pictureEntrepreneurship & creativity:Have the ambition and passion to drive value and impact with a “can-do” attitude, willing to take calculated riskAdopt an open and creative mindset to pilot new concepts and overcome challengesHigh learning agilityStrategic thinking:Support strategic clinical development within Biotech Unit; integrate business case, mitigate risks and manage resourcesAdaptability: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.Cross-functional knowledge & expertise:In-depth medical knowledge to drive operational excellenceSufficient experience and ability to work in an environment that requires seamless cross-function collaboration and handling complexityCritical Competencies & Experience:Proven ability to effectively work in a cross-region, cross-function matrix; able to work effectively in diverse cultures, showing aptitude in modifying styleBusiness acumen - understand unmet market needs; provide clear path to win; demonstrated track record in driving innovation through to the global commercialization of assetsAble to effectively communicate at multiple levels of the organizationDirect Reports:NoTravel Required:Up to 20% . Ability to travel domestically and internationallyCompetencies: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.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.

Full-time
  • ID: #50069559
  • State: California Emeryville 94608 Emeryville USA
  • City: Emeryville
  • Salary: USD TBD TBD
  • Showed: 2023-06-10
  • Deadline: 2023-08-09
  • Category: Et cetera