Ambrx®, Inc. is an established biopharmaceutical company with a mission to deliver breakthrough protein therapeutics using an expanded genetic code. Unlike conventional conjugation techniques that create a mixture of suboptimal molecules, Ambrx technology combines site specific conjugation with proprietary linkers, payloads, and pharmacokinetic extenders to create a single molecular species that is optimized for safety, efficacy, and biophysical properties. We call this process Protein Medicinal Chemistry™.
Ambrx is seeking a successful Chief Medical Officer who thrives in a fast-paced environment to develop, implement and manage all clinical activities involving Ambrx’s investigative products. Includes development of clinical strategies, medical affairs oversight, development plans, protocol design, assessment of study results and management of regulatory processes. The Chief Medical Officer will work closely with the CEO and other key leaders to provide clinical insight and medical direction to the company and will help shape product development strategies.
- Responsible for the clinical development, planning, operation, implementation, patient advocacy, and oversee medical affairs
- Lead and supervise the global clinical development and operation teams in US and China;
- Oversee the analysis and interpretation of clinical study results, and the reporting of clinical trial results
- Provide clinical support and work with the management team and R&D department to develop the overall corporate strategies in the new drug development
- Ensure clinical trials are legally compliant to global regulatory processes
- Develop clinical trial strategies and interactions with health authorities, according to domestic and global GCP regulations
- Establish and maintain relationships with key medical experts, field leaders, and maintain alignment with the company’s business plans and development goals
- Communicate and interact effectively with the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators/partners
- M.D. with board certification in oncology
- Minimum of 8 years of experience in medical leadership in the pharma industry
- Minimum of 8 years clinical trial experience
- Extensive experience in clinical practice treating patients and experience as a sponsor working on investigational new drugs.
- 8 years of management experience leading a clinical group including clinical/medical affairs and clinical operations globally
- A proven success record in Phase I-II clinical research studies and trial design familiar with FDA/EMA/CFDA regulatory requirements;
- Strong interpersonal skills
- Excellent strategic planning, team building and leadership skills
To be considered for this position, please submit your resume/CV referencing the specific position of interest and position code to email@example.com. Applicants whose qualifications and experience most closely match the requirements of the position will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensation & benefits. Equal Opportunity Employer