Job Description:

• Responsible for Pyrotech’s Phase I-III and investigator-initiated clinical studies, can be initiated, conducted, and closed according to established timelines and plans. Identify risks and resolve issues.
• Collaborate with internal and external cross-functional stakeholders to identify and select study vendors, including but not limited to CROs, laboratories, SMOs, etc. Negotiate quotes and contracts.
• In addition to clinical operations activities, serve as the primary coordinator of a study to lead and facilitate study team to in developing and reviewing study plans—including project timelines, investigational product supply plans, essential documents, and project plans—ensuring their reasonableness and completeness.
• Manage CROs and other third-party vendors (e.g., labs, SMOs, PROs), including financial activities and their performance. 
• Oversee site management activities, including site feasibility & selection, site initiation, CRA monitoring, quality-related activities, data, documentation, and safety management, and site close-out.
• Monitor key milestones throughout the study lifecycle, proactively identify risks, and resolve issues in a timely manner to ensure studies are executed within planned scope, schedule, budget, and acceptable quality.
• Report project progress regularly or as required. Establish and maintain effective communication and collaboration with internal and external partners, key opinion leaders, and investigators throughout the study period.

Qualification:

• Bachelor’s degree or master’s degree in a medicine-related discipline
• For Senior CTM, no less than 7 years of total working experience include at least 3 years of clinical operations project management experience. For CTM no less than 5 years of total working experience include at least 1.5 years of clinical operations project management experience.
• Experience with managing global study or the clinical studies conducted oversee is a plus
• Knowledge of the relevant drug development process including project and site management, local and international regulations, ICH-GCP, drug safety requirements, data management processes, budget and vendor management and other functions or industry knowledges.
• Ability to travel extensively within country and rarely for Intercontinental trave as well.
• Excellent communication skills
• Fluent written English, fluent spoken English is a plus. Proficiency in Chinese is a plus (for abroad candidates only)
• Ability to handle high volume of work and tight deadlines
• Proficiency in MS Office, including Word, Excel, and PowerPoint.

Job Description:

• Overall responsibility for drug substance and drug product activities from preclinical development through clinical supplies for Phase 3 registration studies. 
• Identification, selection and management of Contract Development and Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacture and supply of Drug Substance (API) and Drug Product (DP).
• Develop and implement strategy and design of experimentation for optimizing and controlling quality of bulk API and DP using CDMO. 
• Delivery of robust, scalable and cost-effective manufacturing routes and drug product formulations that meet or exceed the target clinical profile.
• Projection of API and DP needs for preclinical and clinical programs (with clinical team), and associated budgets (with finance team). 
• Formulation design/development in support of clinical studies.
• Management of supply chain and logistics in support of clinical studies. 
• In coordination with Quality Assurance, implement stage appropriate analytical methods and protocols and ensure that all CDMOs are using systems and processes in compliance with all relevant regulatory standards.
• Execute plans for the validation and registration of API and DP as required by cGMP, ICH (International Conference of Harmonization) and NMPA / FDA regulations. 
• Writing and reviewing documents for INDs / regulatory section submissions; represent the company as the CMC expert before China and U.S. regulatory authorities. 
• Prepare, review or edit cGMP batch records, CMC regulatory and Quality documents. 
• Prepare technical reports, publications and oral presentations. 

Qualification:

• Substantial experience in managing China and International CDMOs for the manufacture of cGMP APIs and DP.
• Substantial experience with projects in clinical development e.g. Phase 1 through Phase 3 including multiple pharmaceutical dosage forms (e.g. tablets, capsules, topicals, etc.) .
• Experienced with cGMP manufacturing and IND and NDA filings; thorough knowledge of relevant NMPA and FDA regulations. 
• At least 10 years relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment. 
• Experience in supply chain management .
• PhD or MS with 10+ years of experience; Advanced degree in Organic Chemistry or related scientific discipline is preferred. 
• Able to identify and resolve critical issues. 
• Experience implementing technical, strategic and operational plans. 
• Excellent written and verbal communication skills, exceptional interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators).