Position Overview & Responsibilities
We are seeking a motivated, skilled, and articulate Medical Director, Clinical Development, to play a key role in the development, conduct, and analysis of clinical programs in the field of hearing, including drugs to protect, repair, and restore hearing. The position will report to the Chief Medical Officer and will involve intense collaboration with academic investigators/ scientific experts to develop outstanding clinical protocols and ensure optimal study conduct, including development of data collection and study reporting systems and adherence to GCP guidelines and other relevant health authority regulations.
- Responsible for developing and implementing the Development Strategy for assets assigned, including the design, conduct, and interpretation of data from Phase 1 and 1/2 studies, as well as oversight of clinical pharmacology and pediatric studies as required to fulfill regulatory requirements.
- Provide clinical development input to pre-clinical programs approaching IND-enabling tox.
- Bring programs into the clinic.
- Direct all aspects of activities relating to: preparation of protocols, clinical trials, data analyses, and written study reports, including being the medical monitor for clinical trials.
- Develop strong network of clinical advisors to provide input on Decibel’s clinical development programs and to serve as investigators on studies.
- Lead study teams to ensure that the clinical aspects of protocols are properly executed.
- Oversee feasibility assessment and investigator/site selection.
- Interact with CRO and other vendor relationships.
- Serve as primary interface with internal stakeholders as well as external thought leaders and regulatory authorities for assigned programs.
- As business needs require, provide technical evaluation of business development activities for proof of concept stage hearing assets.
- At least 3 years in pharmaceutical industry with experience in leading clinical trials supporting registration and interaction with global regulatory authorities.
- Professional credentials as a physician (MD).
- Experience in audiology, otolaryngology, or neurology preferred.
- Experience in running gene therapy trials preferred.
- Experience in leading and managing project teams and managing multiple projects concurrently.
- Thorough knowledge of clinical trial approval processes, including a strong grasp of international guidelines and regulations (FDA, ICH, and GCP).
Additional Desirable Experience
- Excellent oral and written communication skills as well as the ability to facilitate analysis and problem solving through the effective facilitation of group activities.
- Strong organizational and time management skills, including the ability to function effectively in a team environment.
- Demonstrated professionalism and adherence to high ethical standards.
- Demonstrated ability to manage multiple priorities to achieve results and meet milestones in a “hands-on” fashion.