Summary of Position:
To address Yisheng’s increasing clinical needs, the Company is seeking a physician-scientist to serve as a Director within the Clinical Development to drive the clinical research strategy across the portfolio of vaccine and drug candidates. The Director, Clinical Development will report to the CMO and will oversee the clinical development of Yisheng’s pipeline. S/he will be expected to ensure that all programs meet quality and safety standards required by the medical community and regulatory agencies. The Director will be primarily responsible for developing and executing an integrated clinical trial program including protocol design and medical oversight of ongoing studies. He/she will be responsible for obtaining scientific advisory input, work with biostatisticians for study design and analyses, support regulatory interactions for product advancement, and work closely with operations to provide advice and decision making regarding medical input to achieve operational excellence. The candidate must have demonstrated strong collaborative skills to work across various phases of clinical development. Medical insight across a myriad of functions from discovery to manufacturing are expected. Prior experience in a Biotech environment will be highly beneficial, as this role will be working on product development in an extremely fast paced and intense environment.
Summary of Essential Duties:
1. Assist in the development of Yisheng’s clinical research strategy for product candidates across preclinical development, clinical research, manufacturing and regulatory affairs.
2. Manage internal and external resources to ensure clinical research plans are executed on time and within budget.
3. Develop clinical trial protocols, investigator brochures, and other documents required to conduct clinical trials.
4. Oversee management of clinical trials including investigator selection, analysis of patient recruitment strategies, milestones, coordination of lab samples, data collection and analysis.
5. Identify suitable clinical trial sites and develop effective working relationships with clinical investigators and thought leaders.
6. Oversee medical review of adverse event reports and monitoring of incoming safety data in conjunction with product safety/pharmacovigilance, including evaluating and escalating safety signals; ensure that sites and regulatory agencies are notified and all company and regulatory procedures are compliant.
7. Manage CRO’s; including identifying suitable partners, defining CRO responsibilities, communication plan, divisions of responsibility, milestones, contracts, reviewing monthly status reports, and maintaining interactive management to ensure project success
8. Planning, reviewing and editing Clinical Study Reports
9. Providing input on the design of preclinical studies supporting clinical strategy
10. Oversee regulatory filings, including drafting, editing and preparing of routine correspondence and sections of INDs, BLAs, NDA’s, Annual Reports, Amendments, Supplements, Orphan Drug Applications and other regulatory submissions.
11. Oversee development and maintenance of clinical SOPs related to GCP activities.
12. Ensures that all Yisheng’s drug and vaccine clinical programs are conducted in accordance with Good Clinical Practice (GCP), ICH guidelines and all applicable regulatory requirements.
13. Provide expert opinion and due diligence research on business development opportunities.
14. Represent Yisheng’s clinical and medical strategy to internal and external stakeholders including the Board of Directors and investors
Summary of required/desired knowledge, skills, and other abilities or attributes:
For this role you will need
· Medical degree/MD
· Minimum five (5) years in either clinical practice or relevant setting, clinical research experience
· Minimum one (3) year in pharmaceutical industry (clinical research, pharmacovigilance, or Medical Affairs) or equivalent
· Functional knowledge of concepts in vaccine immunology and vaccine development, preferably with experience in design and conduct of clinical trials
· Working knowledge of clinical development pathways in China
· Experience in vaccine clinical research preferred
· Experience in global clinical trial setting preferred
· Knowledgeable in medicine and pharmaceutical product safety
· Experience applying medical knowledge to the interpretation of individual case review
· Evidence of effective leadership skills
· Good verbal and written communication skills (both Chinese and English)
· Ability to work cross-functionally