Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company’s pipeline continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those living with autoimmune and rare diseases.
We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation – TRUE Innovation!
Position Summary
The AD/SD, Clinical Development will work across the spectrum of clinical programs within Zenas to provide scientific and strategic leadership for activities in clinical development and portfolio strategy in APAC region, and be actively involved in global development. He or she will also support business development, including due diligence, and foster innovation and external collaboration as needed.
Key Responsibilities
- Provide disease expertise to therapeutic area and work out China-tailored development strategy from end to end;
- Lead and drive the molecule development plan in China, transform strategy into execution plan;
- Provide clinical/scientific input and support as medical monitor in trials, e.g. site visit, training CRA on study design, act as speaker in investigator meetings, support ethics approvals, data review, regulatory filings preparation, support to inspection from China local side;
- Assess and drive new indication approval;
- Author for clinical document of Chinese data for CTN and MAA filing and publication, interpret clinical trial data and participate in China healthy authority interaction;
- Lead peer to peer discussion in consultation with KOLs/Medical Advisory Boards Meetings/Expert Panels.
Required Skills and Competencies
- Medical Doctor is preferred but not limited
- 2 years or more clinical practice experiences, autoimmune disease is preferred but not limited
- 2 or more years of clinical research experience in the bio pharmaceutical industry (biotech, pharmaceutical), experience in autoimmune disease/ophthalmology/Rheumatology/hemotology is preferred
- Experience with clinical study management and conduct
- Experience with scientific expert interactions
- Fluency in English, both oral and written communications
- Familiarity with concepts of clinical research and clinical trial design, including biostatistics
- Knowledge of Good Clinical Practices (GCP), FDA, EMEA/CHMP and NMPA regulations and guidelines, and applicable international regulatory requirements
Zenas BioPharma is proud to be an equal opportunity employer. We are committed to fostering an environment where diversity is valued. All qualified applicants will receive consideration for employment based on merit, qualifications and the needs of the business.
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