Company: THIRD ROCK VENTURES, LLC
Posted on: April 10, 2021
Medical Director at Decibel Therapeutics We are seeking a
motivated, skilled, and articulate Medical Director to play a key
role in the development, conduct, and analysis of gene therapy
clinical programs in the field of hearing and balance. The position
will report to the Vice President of Clinical Research and will
collaborate 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
- Develop and maintain 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
- 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
- As business needs require, provide technical evaluation of
business development activities for proof of concept stage hearing
- Professional credentials as a physician (MD)
- Prior clinical development experience in pharmaceutical
industry leading the design and execution of clinical trials,
supporting registration, and interacting with global regulatory
- Strong scientific skills in addition to clinical training
- Experience in audiology, otolaryngology, ophthalmology, or
- 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) and interactions with regulatory
- 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
- Demonstrated ability to manage multiple priorities to achieve
results and meet milestones in a "hands-on" fashion. Decibel
Therapeutics, Inc. is proud to be an Equal Opportunity Employer.
Our goal is to have a diverse workforce. We do not discriminate on
the basis of race, age, color, religion, national origin, gender,
sexual orientation, gender identity or expression, veteran status
or disability, or any other status protected under federal, state,
or local law.--All employment is decided on the basis of
qualifications, merit, and business need. 29 Newbury Street
Boston, MA 02116
P (617) 585-2000
Keywords: THIRD ROCK VENTURES, LLC, Boston , Medical Director, Executive , Boston, Massachusetts
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