Director for Clinical Development
We are searching for a Director for Clinical Development to work in our Baltimore, Maryland, facility. He/she 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 CROs as needed to support human clinical trials.
- 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 project management. Strong writing skills. Knowledge of the US regulations concerning the conduct of clinical studies is a plus. Experience with infectious diseases is not required, but is preferred.
Please send a cover letter with a summary of experience, resume, and the names and contact information of at least two references to:
Dr. Alexander Sulakvelidze
The Columbus Center
701 E. Pratt Street
Baltimore, MD 21202.
Applications also can be faxed to 410-625-2506, or e-mailed to firstname.lastname@example.org. No phone calls please.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire. At the present time, Intralytix, Inc. is unable to support visa applications; therefore, all applicants must be already eligible for employment in the United States. Intralytix, Inc. is an equal opportunity employer.