We are looking for talented, skilled, science-focused individuals who want the opportunity to work with top scientists, build valuable relationships, contribute to high-performing teams, and grow with us as we continue to forge a new path to fight cancer and improve the lives of patients.
Come learn with us, grow your career, and make significant contributions as we work to improve the lives of people with cancer through the development of precisely-targeted medicines with differentiated mechanisms of action.
If you are interested, please submit your resume to HR@angelpharma.com
1. Manages clinical projects from concept through clinical study report completion. 2. Leads the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc. 3. Participates in CRO and other vendor selection, negotiation and management. 4. Tracks study timelines, budget, and quality metrics. 5. Ensures GCP and regulatory compliance. Responds promptly to study questions and issues raised by investigative sites, CROs and vendors. 6. Participates in meetings with investigative sites, key opinion leaders and consultants as needed.
1. Bachelor or above in Medicine, Life Sciences, or Pharmacy. 2. At least 5 years of clinical research experience in pharmaceutical industries or CROs, and a minimum of 2 years project-lead or management experience. 3. Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management. 4. Proficient in English.
1. Responsible for overall regulatory strategy & timeline, developing optimal registration strategy for projects. 2. Responsible for the preparation and validation of registration dossiers; ensure the dossiers are in compliance with health authority regulation and their timely submission and approval. 3. Ensure timely, clear communications on project regulatory status/issues/risks with management, and with health authorities as appropriate. 4. Develop and implement internal processes and system to support regulatory submissions and approvals. 5. Maintain up-to-date knowledge and expertise of relevant guidelines and regulations.
1. Bachelor or above degree in Life Sciences, Pharmacy or Medicine.
2. At least 5 years of regulatory affairs experience in pharmaceutical industry. Prior global regulatory experience in development is preferred. Prior oncology product experience is preferred.
3. In-depth knowledge of regulatory environment, regulations & guidelines.
4. Proficiency in English (oral and written).
1. Contribute to the writing of clinical research related documents including clinical trial protocol, Investigator’s Brochure, and clinical study report. 2. Provide input for clinical research strategies for projects. 3. Provide scientific expertise for product registration as needed. 4. Ensure clinical excellence in execution and oversight of development stage studies with cross function teams. 5. Supervise medical monitoring activities, assessing and handling issues related to protocol conduct and/or individual subject safety. 6. Contribute to the preparation of the dossier and responds to the CDE/FDA in a timely fashion during any stage of clinical trial proceeding. 7. Support the development of reliable and high value publication strategies for the products. 8. Build strong relationships and ties with outside stakeholders, including with key opinion leaders. 9. Lead clinical and scientific advisory boards and liaises with key opinion leaders to generate ideas for future product development, and scientific communication of safety/efficacy of current products. 10. Provide clinical input to support BD opportunities for new products. 11. Ensure ICH-GCP, local regulatory and global policy compliance. 12. Provide TA/product related trainings to clinical study team members and other related stakeholders.
1. Master or above degree in Medicine. 2. At least 5 years of pharmaceutical industry experience working as CRP or medical advisor/scientist/MA/MSL, familiar with clinical development strategy drafting, clinical study protocol writing, medical monitoring and CSR drafting. 3. Good understanding of the overall drug development process, clinical trial methodology, China regulatory environment, ICH/GCP Guidelines and related FDA/NMPA clinical development guidelines. 4. Excellent communication skills, self-motivated, innovative, with highest level of professional ethics, accountability. 5. Proficient in English (oral and written).
1. Serve as a program level clinical pharmacology lead and a PK/PD content expert and has a broad range of responsibilities that include developing and prioritizing strategic, tactical, and participation in multiple matrixed research and development teams. 2. Contribute to early development and clin pharm strategy, as well as the planning and implementation the appropriateness of study designs, and generate high quality of data, adherence to Good Clinical Practices to meet both domestic and international requirements. 3. Contribute to the preparation of submission documents to health authorities. 4. Work with cross-functional team to establish project success criteria, monitoring project progress, and communicating information to management. 5. Ensuring that clinical pharmacology requirements are understood and incorporated upfront from product concept development. This helps ensure that products are developed in a way that will facilitate prompt regulatory approvals with competitive advantages in the intended markets. 6. Participate in assessing new product opportunities and identifying requirements for projects under consideration, including evaluation of clinical pharmacology and clinical efficacy data owned by external organizations with regard to potential product acquisitions or partnering in product development.
1. Ph.D. in Pharmacology or PharmD with a minimum of 5 years of industry experience is required. 2. Prior experience in oncology drug development and interactions with regulatory authorities is preferred. 3. Knowledge in drug metabolism, pharmacokinetics, pharmacodynamics, clinical trial design, and regulatory requirements for drug development is required. 4. The ability to work in a matrix environment with global/local cross-functional teams is essential. 5. Excellent communication skills, self-motivated, innovative, with highest level of professional ethics, accountability. 6. Proficient in English (oral and written).