Chief Medical Officer
San Francisco, CA, USA | N/A
Industry:Pharmaceutical / Biotech
Job Description:54 people have viewed this job
The Chief Medical Officer will report directly to the Chief Executive Officer. The primary role of the CMO will be to provide leadership and direction for the company’s pipeline of clinical development programs in hepatitis B and microbiome. The CMO will be responsible for the strategy, direction and execution of the company’s clinical development plans. The CMO will be a key member of the senior management team which determines and oversees research and drug development and sets the overall strategic direction of the company. This is a unique opportunity to have an impact on the success of a well-positioned, well-financed biotechnology company.
- Participate as an active member of the senior management team to develop and implement the strategy and vision of the Company with respect to clinical development
- Provide strong clinical and scientific leadership and function as a key liaison between the Company and its external scientific advisors and clinical consultants
- Plan and implement clinical development of the Company’s products consistent with corporate goals and timelines and compliance requirements
- Provide clinical and scientific and expertise in support of business development activities
- Represent Assembly at scientific meetings with high visibility at the level of professional peers
Preferred Qualifications Include:
- MD with Board Certification in infectious disease, immunology, or other related field
- At least 10 years of combined experience academia, clinical practice and industry working on development of new drug candidates
- Multiple years of management experience in clinical drug development overseeing the design, planning and execution of clinical studies, and interface with development functions including Regulatory Affairs, Clinical Operations, Biometrics, Project Management and Clinical Supplies
- A proven success record in Phase I-IV clinical studies as well as the successful submission of INDs and marketing approval-directed filings (BLAs, NDAs, and MAAs)
- Knowledge of relevant FDA regulations and guidelines and other key health authorities (e.g., EMA, PMDA); experience in interactions with FDA personnel is essential; experience in interactions with other health authorities a plus
- Experience with, or strong knowledge of virology drug development is desirable
- Experience in translational medicine, clinical pharmacology and early stage development is desirable
- Excellent communication skills and capable of articulating the Company’s clinical and regulatory strategies to a wide audience including the CEO, the Board of Directors, Company employees, therapeutic area leaders and the investor community
About Assembly Bio
(NASDAQ: ASMB) is a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome. The HBV program is focused on advancing a new class of potent, oral core inhibitors that have the potential to increase cure rates for chronically infected patients. The microbiome program is developing novel oral live microbial biotherapeutic candidates with Assembly Bio’s fully integrated platform, including a robust process for strain identification and selection, GMP banking and production, and targeted delivery to the lower gastrointestinal tract with the GEMICEL® technology.
We believe our Microbiome platform represents a best in class approach to developing biopharmaceutical agents from live biotherapeutic products. ABI-M201, our lead program in mildly to moderately active ulcerative colitis (UC), is currently in a phase 1b clinical trial. This program is part of a broader collaboration we established with Allergan in 2017 for gastrointestinal programs such as UC, Crohn’s disease and Irritable Bowel Syndromes. Our internal pipeline comprises first in class or best in class live microbial biotherapeutic approaches in areas such as oncology, immune mediated and metabolic disorders, and other areas of high medical need.
We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add to our dynamic team of great people who are driven to transform the lives of patients.
Assembly Bio is headquartered in Carmel, Indiana, while the R&D headquarters is in South San Francisco. The Company also has a microbiome manufacturing facility in Groton, CT, and offices in China. Assembly Bio has a strong balance sheet having raised approximately $166 million in July 2018. We are positioned well to build the next phase of the Company toward global development and commercialization of our innovative medicines in HBV-cure and the Microbiome.
is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.