CAREERS - CHIEF MEDICAL OFFICER
New Biotic Inc. is a clinical stage biotech company focused on microbiome research. It has researched the gut-brain connection since 2008. NBI’s R&D efforts focus on the root causes of central nervous system (CNS) disorders, rather than just symptom management. The company has developed a potentially game-changing treatment for amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. It has obtained exciting, initial pivotal human data based on a proprietary microbiome formulation that works as a disease modifying therapeutic for ALS. The treatment, RaphaLX™, was granted Orphan Drug Designation (ODD) by the FDA.
New Biotic Inc. is currently looking for a Chief Medical Officer who will provide leadership and strategic direction to New Biotic’s pipeline of neurologic and psychiatric-related clinical projects. The CMO will oversee these clinical studies from human proof of concept to FDA approval, which involves ensuring the product complies with global regulatory, legislative and medical/health requirements. The CMO will report directly to the Chief Executive Officer under the guidance/supervision of the company’s Chief Scientific Officer and will be a key member of the senior management team which oversees and determines the overall strategic direction of the company. This will be a wonderful opportunity to be a part of exciting medical breakthroughs that will impact the ALS community, among other communities impacted by neurologic and psychiatric disorders.
· Direct the development of clinical strategies and plans to integrate New Biotic Inc. products into standard practice: from human proof of concept through product approval.
· Orchestrate and manage clinical aspects of regulatory strategies and ensure clinical development programs meet quality and safety standards.
· Act as primary spokesperson for the company and lead interactions with key opinion leaders at scientific conferences and advisory boards, as well as academic lead researchers, investigators, journalists, press, special interest groups and associations, and other clinical stakeholders.
· Represent the company to work with global regulatory and legislative agencies, addressing the scientific and medical/health aspects of product inquiries.
· Provide all aspects of clinical support.
· Assume all responsibilities of Chief Clinical Officer until such activities require a full-time CCO.
Qualification, Skills and Abilities
· Medical and/or PhD. degree in neurobiology-related discipline highly preferred.
· Substantial clinical development and execution experience.
· Ability to handle multiple clinical studies in parallel.
· Experience in interactions with CRO & FDA officials are essential.
· Experience or knowledge of orphan drug development are essential.
· Scientific, technical, and regulatory understanding or experience with most of the functions involved in the development of a biopharmaceutical product are highly desirable.
· The successful candidate will read, write, and speak fluent English, possess excellent communication skills and will be capable of articulating the company’s clinical and regulatory strategies and progress to a wide audience including the CEO, the Board of Directors, company employees, press, journalist, professional associations, special interest groups, and the investor community.
· Prior experience with reviewing promotional materials to be used by the company.
· In-depth knowledge of clinical studies, GcMP, GLP, GCP and ICH guidelines.
· Experience in ALS and/or microbiome research and publications.
· Previous experience as a CMO or CCO of a biotech company.
· Experience working with Europe, Japan, China or India’s health and regulatory authorities.
· Has excellent leadership and interpersonal skills; should have proven skills as an effective team player who can engender credibility and confidence within and outside the company.
· Ability to handle ambiguity, making positive use of the opportunities it presents, and quick adaptation to changing circumstances.
· Able to adapt to multi-cultural work environments.
· Open-minded & hands-on; willingness to learn new skills and knowledge and take on both “important” as well as “small” tasks and duties on different levels.
· Must have the highest personal values and ethical standards and possess excellent judgment and strong decision-making capabilities.