Beigene


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Assistant Medical Director

  Company :     Working Hours :  

  Job Type :  

Full Time



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 Associate Medical Director, Clinical Development will support BeiGene Clinical and Medical assets by successful execution of clinical development programs and deliverables in partnership across the organization; with external vendors; and with external academicians and collaboration partners. The candidate will report to the Senior Medical Director, Clinical Development.

As a leader in the organization, the incumbent will be accountable to execute on clinical trials and contribute to clinical strategy on the study teams. Specifically, the incumbent will work closely with colleagues in clinical science, program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and translational research.

Education Required:

  • MD required.

Experience

  • Minimum of 3-5 years of clinical research experience within biotech/pharma or within an equivalent academic environment

  • Clinical oncology experience; candidates with exceptional experience in other therapeutic areas would be considered if they demonstrated clear potential to apply their existing skills to oncology

  • High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills

  • Knowledge of GCP and ICH Guidelines

  • Flexibility to work with colleagues in a global setting

  • Able to engage in work-related travel approximately 15%

  • Experience with the development and support of related SOPs and policies is expected.

Capabilities and Competencies

  • Values based collaborator – respectful, accountable and collaborative

  • Ability to relate and work with a wide range of people to achieve results

  • Impactful written and verbal scientific communication; including writing protocols, health authority documents, manuscripts, presentations

  • Successful and superior influencing skills across all levels of the organization and external collaborators

  • Problem solving and risk-mitigation skills

  • Confident, positive attitude, enthusiastic and charismatic

  • Appreciation of diversity and multiculturalism

  • Strategic and creative thinker

  • Ability to build working relationships throughout the organization and with business partners to achieve business goals

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

  • 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 BeiGene colleagues, CRO staff, and 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, and CROs

  • 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 subteams

  • Create clinical study or program-related slide decks for internal and external use

Computer Skills :

  • Efficient in Microsoft Word, Excel, Powerpoint, and Outlook

Travel:

  • Work related travel approximately 15%

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, non-disqualifying physical or mental 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.

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, non-disqualifying physical or mental 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.

 Location: San Mateo.  How to get there?

 Location: San Mateo.




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