Department: Biomarker Development & Translational Research
Reports To: Mitch Raponi (VP)
The Associate Director Diagnostic Alliance Management will support the review of potential Diagnostic partnership proposals, execution of such partnerships, and management of Joint Project Teams. The incumbent will have knowledge of diagnostic test development processes including design requirements and companion diagnostic regulatory submissions. The Alliance manager will support the Biomarker test development across BeiGene’s drug portfolio in both the Hematology and Immuno-Oncology Clinical Development programs.
Essential Functions of the job:
- Partnering with Project Management, Biomarker & Translational Research, Clinical Development, Regulatory, and other functions to ensure BeiGene maintains successful partnerships with third-party diagnostic organizations
- Provides project management support to Biomarker and Companion Diagnostic Joint Project Teams
- Ensures cost, quality, and timeliness of diagnostic programs align with plans
- Builds relationships with external CROs
- Develops MSAs and SOWs with vendors
- Ensures that external diagnostic vendors are selected and managed appropriately to deliver within established timelines and financial investment
- Successful interaction with the China Clinical Biomarkers team to support Dx development for global clinical trials
- Contributes to business development activities including diligence of Biomarker CROs
Experience and Education:
- Advanced degree (eg MSc) within a diagnostic or related scientific profession required
- Minimum of 10 years of experience and success within other biotech/pharmaceutical and/or diagnostic companies, with 5 or more years in biomarker research is required
- Professional knowledge and hands-on scientific expertise and skills in developing novel biomarker platforms is required
- Knowledge of oncology drug development is preferred
- Prior experience with vendor selection and management is required
- Working knowledge of CDx development and applicable knowledge of Federal guidelines and regulations is required
- Experience with the development and support of related SOPs and ICF’s is required
- Experience with partnerships and strategic alliances is required
- Experience working in global environment is preferred
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 within budget
Location: San Francisco Bay Area: Emeryville or San Mateo
Travel: 20% of time including some international travel