Senior Manager, Clinical Science at BeiGene

, , United States -

Full Time

Start Date

Immediate

Expiry Date

14 Jun, 26

Salary

186800.0

Posted On

16 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Development, Protocol Development, Informed Consent, Investigator Brochures, Clinical Study Reports, IND Submissions, NDA Submissions, Data Review, Data Analysis, Scientific Interpretation, GCP Compliance, ICH Guidelines, Budget Planning, Risk Analysis, Health Authority Interaction, CRO Management

Industry

Biotechnology Research

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. General Description: The Senior Manager – Clinical Science will support BeOne Clinical and Medical assets in the successful execution of clinical development programs and deliverables working in partnership across the organization (clinical development, program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and translational research), with external vendors, and with external academicians and collaboration partners. The Senior Manager will support clinical program activities and help assure they are executed within expected scope, budget and timelines. Key Responsibilities: Facilitate the generation of, 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), Developmental Safety Update Reports, Health Authority briefing documents, Orphan Drug applications, and annual reports Risks / benefits analysis for applicable documents Assist with clinical development tasks pertaining to study start up, maintenance, and closeout activities Partner with Clinical Operations and other functional areas for the successful implementation and execution of clinical studies Support Clinical Operations in clinical trial budget planning and management Contribute to or perform therapeutic area/indication research and competitor analysis Review, query, and analyze clinical trial data Interpret, and present clinical trial data both internally and externally Provide scientific support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs Create clinical study or program-related slide decks for internal and external use Develop, track, execute and report on goals and objectives Be accountable for compliant business practices Managerial Responsibilities: None Required Competencies Clinical Development Expertise Demonstrates basic knowledge of clinical study design, including familiarity with Phase 1-4 trial activities and standards, and GCP and ICH guidelines Able to complete data review and analysis activities Able to analyze and interpret scientific literature Problem Solving Analyzes, evaluates, and solves problems accurately in own area of work Exhibit good organizational skills with the ability to multitask and prioritize assignments independently to meet deadlines Communications Observes and listens for main points in communications from others, suspends bias and asks clarifying questions and/or summarizes to confirm understanding Communicates ideas and intentions in a clear, timely, practical manner Ensures that important information is consistently shared with managers, peers and business partners in a timely manner to enable effective decision-making and/or execution Selects most appropriate communication method for optimal outcome (e.g. uses phone/in- person vs email) Teamwork Fosters mutually beneficial working relationships Demonstrates ability and willingness to actively participate and contribute to group efforts Develops and maintains strong working relationships with people across the department and in cross-functional teams In a team environment, demonstrates eagerness to support others’ efforts Qualifications: PharmD; or PhD within a clinical and/or scientific profession; MD (or equivalent) Minimum of 3+ years relevant experience in clinical research and development within the pharmaceutical industry, biotech, CRO or equivalent Travel: Approximately 25% of work may involve domestic and/or international travel 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: $141,800.00 - $186,800.00 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. BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram. For more information, please visit the link to explore job opportunities in China Mainland. China Mainland Job Posting At BeOne, 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 First Driving Excellence Bold Ingenuity Collaborative Spirit

Responsibilities

The Senior Manager will support clinical program activities, ensuring execution within scope, budget, and timelines by partnering across various internal functions and external collaborators. Key duties include facilitating the generation, updating, and review of essential clinical documents like protocols, CSRs, and regulatory submissions.