Clinical Director

We are searching for a Clinical Director to work in our Baltimore, Maryland, facility. The Clinical Director oversees and heads all efforts to develop and market the company's phage-based human health products, both for the "probiotic" and "clinical" markets and applications. The selected applicant will be responsible for, but not limited to, the following:

• Developing and implementing strategic plans and budgets for early and late stage clinical development programs.
• Participating in all relevant fund-raising efforts to support the Company's clinical development business and other businesses as necessary.
• Participating in grant-writing and project-development to secure external funding for product development from conceptualization through clinical evaluation.
• Leading the efforts to assemble and submit IND applications to the FDA for various phage-based human health products.
• Working closely with the Company's development partners on co-developing and/or regulatory approvals for various phage-based products for different human health applications.
• Analyzing incoming clinical data to ensure that documentation from investigators and investigational sites meets FDA requirements.
• Preparing and reviewing documents for publication, presentation, and/or regulatory submission (including IND submissions); working with CRO/s as needed to support human clinical trials; coordinating submission of documents to regulatory agencies and local site IRBs.
• Designing and developing study protocols, case report forms, and informed consent forms.
• Managing and serving as the main liaison for the performance of clinical trials by the CROs, Company partners, and third parties that conduct those trials under the contract with the Company.
• Analyzing and controlling expenditures of the division to conform to budgetary requirements.
• Helping identify potential licensing opportunities and partners for distributing our human health products globally.

Skills / Qualifications

An M.D. (preferred) and/or PhD degree, and a demonstrated experience in clinical trial design and management (including interactions with IRBs and FDA). Strong writing skills. Good knowledge of the US regulations concerning the conduct of clinical studies. Experience in infectious diseases is a plus.