BeiGene
BeiGene

60 Beigene Director Of Program Management Jobs Hiring Near You

... of clinical development programs and deliverables in partnership across the organization; with ... Support budget planning and management * Be accountable for compliant business practices ...

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Director, Global Regulatory Lead

$153K - $202K/yr

... development programs to secure and maintain market access for product(s) in line with business ... This individual will manage regulatory aspects of compounds through all phases of development, post ...

Executive Director, Regulatory Affairs, CMC

$153K - $202K/yr

The position manages a U.S.-based team of approximately 15 reports and reports to the Global Head ... Lead and oversee regulatory CMC change-control impact assessments for biologics programs, ensuring ...

Category Strategy and External Resourcing This position is responsible for category management of CRO and FSP outsourcing. It partners with cross-functional stakeholders to define outsourcing and ...

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Medical Director, Hematology

$249K - $309K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

This job post has expired today. Applications are no longer accepted.


Job description

BeOne 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 Medical Director, Hematology will support BeOne clinical assets and pipeline by successful execution of clinical development programs and deliverables in partnership across the organization; with external vendors; and with external academicians and collaboration partners. As a leader in the organization, the incumbent will be accountable to assess and execute clinical programs and help assure that activities are executed within expected scope, budget and timelines. The incumbent will play a key role the establishment and growth of Clinical Research functions to assure best-in-class global capabilities and execution. Specifically, the incumbent will work closely with colleagues in clinical development, program management, biometrics, clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and translational research and other functions.
Essential Functions of the job:
  • Facilitate 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
  • 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
  • Partner with clinical operations and other functional areas for the successful implementation and execution of clinical studies
  • Provide scientific expertise for selection of investigator and vendors
  • Train BeOne colleagues, study site staff on the therapeutic area, molecule, and/or clinical protocol
  • Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities
  • Review, query, and analyze clinical trial data • Interpret, and present clinical trial data both internally and externally
  • Represent a clinical study or development program on one or more teams or sub teams
  • Create clinical study or program-related slide decks for internal and external use
  • Build and maintain opinion leader/investigator networks; organize and present at key opinion leader advisory boards and investigator meetings
  • Contribute to or perform therapeutic area/indication research and competitor analysis
  • Build strong relationships with internal experts
  • Identify continuous process improvement opportunities.
  • Identify incremental organizational resource needs - staff, budget, and systems
  • Develop, track, execute and report on goals and objectives
  • Support budget planning and management
  • Be accountable for compliant business practices

Qualifications:
Essential:
  • MD (or equivalent medical degree); board certification or eligibility in relevant therapeutic area (e.g., oncology, hematology)
  • Clinical training with experience in drug development or clinical research, ideally across Phases I-III
  • Strong understanding of clinical trial design, GCP and regulatory environment for submissions (IND, CTA, NDA, BLA)
  • Demonstrated safety oversight skills, familiarity with DSURs, PSURs, and safety committees
  • Excellent communication skills, capable of engaging internal teams, external partners, and regulators.

Preferred:
  • Proven track record in therapeutic area development (hematology or oncology)
  • Experience or familiar with translational medicine, PK/PD data integration, or biomarker strategies.
  • Prior involvement with Life Cycle Management and commercial interfacing
  • Global clinical trial experience across multiple geographies

Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
  • Fosters Teamwork
  • Provides and Solicits Honest and Actionable Feedback
  • Self-Awareness
  • Acts Inclusively
  • Demonstrates Initiative
  • Entrepreneurial Mindset
  • Continuous Learning
  • Embraces Change
  • Results-Oriented
  • Analytical Thinking/Data Analysis
  • Financial Excellence
  • Communicates with Clarity

Salary Range: $249,800.00 - $309,800.00 annually
BeOne 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 BeOne Medicines 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. BeOne 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.

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About BeiGene

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BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235) is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are expediting development of our diverse pipeline of novel therapeutics through our own capabilities and collaborations. We are committed to radically improving access to medicines for two billion more people by 2030. BeiGene has a growing global team of over 8,200 colleagues across five continents. For more information, please visit www.beigene.com .

Industry

Health care and social assistance

Company size

5,001 - 10,000 Employees

Headquarters location

Cambridge, MA, US

Year founded

2010

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