At Clearside Biomedical, we strive to recruit people who share our vision to develop technology that provides a ground-breaking impact to medicine and superior care to patients. We are proud of what we do and believe we create an excellent working environment where every employee contributes to the development of the company.
Clearside Biomedical offers a competitive total compensation package including but not limited to medical, dental, and vision benefits, paid time off, and a matching 401(k) program.
We currently have an opening for a Medical Director to join our team. This role will collaborate with the CSO to assist the company in executing a global strategy for development, submission, approval and life cycle management of a Clearside product. This position is a great opportunity in a Drug & Medical Device Biotech company.
The key responsibilities are:
Collaborates and assists in developing scientifically sound and business driven project strategies including risk assessments and contingency planning in line with the overall strategy of the company
Under the guidance of the Head of Pharmacovigilance, perform medical review of safety information, and specifically SAE’s, from all clinical trials
In conjunction with the Head of Pharmacovigilance, perform monthly reviews of masked safety data from all ongoing clinical trials
Responsible for medical review of all protocols and protocol amendments, including medical review of ICF’s, protocol amendments, case report forms
Perform medical review of protocol deviations
Collaborate in the design of clinical trials from the standpoint of medical strategy
Assist the engineering team in risk management activities including health hazard analyses, DFMEA’s, Use FMEA’s, and Risk Management Plans
May represent the company in scientific organizations, industry associations, standards organizations, and regulatory group meetings regarding clinical and regulatory expertise
Education: PhD, MD, PharmD or Equivalent
Experience: 3 – 6 years of relevant experience with direct involvement in complex research and drug development programs within the pharmaceutical industry
Extensive experience within research and development at any level in the development continuum but with cross-functional experiences