1. Accountable for overseeing the development of the clinical program strategy, tactics and execution.
2. Proactively manage, mentor and direct resourcing within the clinical development group.
3. Manage and direct the team that is responsible for the design and authorship of study protocols and interpretation of clinical study data; author clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR).
4. Lead clinical operations on study implementation and oversight, which includes site and CRO selection and investigator meeting preparation, responsible for the on-time and within-budget execution of protocols.
5. Work closely with Development colleagues, prepare strategy presentations, present and discuss data at relevant team, governance, external consultant, KOL, and regulatory meetings.

1. Direct clinical operations activities for clinical trials ensuring compliance with Good Clinical Practices (GCP), ICH and applicable regulations.
2. Responsible for CRO selection and management, investigator recruitment and selection, study start-up, enrollment, data collection, and drug projections.
3. Develop project plan and timelines to meet corporate goals for timely initiation and completion of clinical studies; identify study risks, develop and implement mitigation strategies for clinical studies.
4. Coordinate effectively with other departments to ensure regular and effective communication with key stakeholders including, regulatory affairs, biostatistics, data management, clinical supply, clinical research, finance, and others, as necessary.
5. Coordinate and contribute to clinical study reports, protocol writing and other clinical documents in conjunction with Medical Writing and clinical pharmacology; develop and implement SOPs and departmental processes for clinical trials.

1. Oversees the regulation process for drug products requiring governmental approval, including filing necessary applications and handling all government interactions.
2. Coordinates inspection of the organization and contract facilities, and develops procedures to ensure regulatory compliance.
3. Assists in coordination and preparation for Agency meetings and associated briefing documents.
4. Manages and supervises queries and commitments from regulatory agencies; collaborates with SME's to provide written responses to queries, and provides periodic status updates regarding conditions/commitments.
5. Provides representation for study-level regulatory activities and participates in cross-functional departmental team projects and product development activities/meetings.
6. Performs research to support regulatory strategy for the assigned clinical development program.
7. Maintains knowledge of regulatory requirements up to date, comments on draft regulatory guidance, and communicates changes in regulatory information as needed.

1. Conduct in vitro, ex vivo and in vivo biology studies, including designing, optimizing and validating experiment methods, and preparing the standardized experimental records and SOPs.
2. Participate in overall study project development and follow the study schedule.
3. Perform critical literature review periodically to advance the study projects.
4. Prepare study reports and documents to support the submission to regulatory agencies, i.e. FDA and NMPA.

QA (Quality Assurance) ensures the development and manufacture of pharmaceutical products are performed in compliance with regulatory requirements.

Responsibilities include but are not limited to: Manage the performance of various quality system elements to ensure compliance, add value, and ensure the quality is a strategic advantage for the Company.

1. Develop the company SOPs and manage the collection of metrics (quality indicators / KPIs) to assess the level of compliance and target areas for improvement.
2. Participate/support in FDA/Regulatory Agency Inspections. Perform compliance-related audits and inspections, and the necessary follow-up actions, to assure that the company is compliant with the applicable regulations.
3. Lead auditing activities to ensure that non-clinical and clinical studies are conducted in accordance with sponsor protocols, GLP/GCP, industry guidelines, and agency regulations.
4. Assist in conducting vendor audits and work with vendors and production support
personnel in eliminating problems via root cause analysis techniques, to ensure that product quality is in compliant and continuously improves.
5. Provide quality review and approval of GLP/GMP/GCP records including but not limited to: Executed Batch Records, SOPs, Policies, Guidelines, Specifications, Quality Control Methods, Validation Protocols and Reports, Analytical Data Packs, and Master Batch Records.
6. Maintain knowledge of regulatory requirements up to date, comment on draft regulatory guidance, and communicate changes in regulatory information as needed.