Careers

Vice President, Clinical Development at Decibel Therapeutics
Boston, MA, US

Position Overview & Responsibilities

 

As VP Clinical Development, reporting to the Chief Medical Officer, you will be accountable for leading the clinical development of Decibel’s products from early phase through Phase 3 and product approval. The VP/Senior Medical Director will work closely and collaboratively with other executive and functional leaders to ensure implementation of well-integrated development strategies and to drive portfolio prioritization. In this role, you will serve as a Decibel spokesperson in external interactions with health authorities, at scientific meetings, and when working with collaborators.

This is both a strategic and an executional role that offers significant opportunities to drive the development of novel, first-in-class therapeutics for protection from hearing loss and genetic restoration of hearing and balance.

 

The Decibel Clinical Development team is focusing on several critical strategic areas, including:

 

  • Changing the way hearing and balance disorders will be diagnosed and treated
  • Evolving the therapeutic area in terms of clinical infrastructure, including the integration of new diagnostic tools and endpoints required to conduct clinical trials for novel therapeutic hearing and balance products
  • Creating a global registry to capture incidence, prevalence, and natural history of target patient populations which will provide new avenues for patient access to clinical trials
  • Executing on early-stage clinical trials that take our lead products through proof of concept
  • Working with a cross-functional team to develop and execute on registration strategies

 

Responsibilities

 

Clinical Programs

  • Identifying, coordinating, and prioritizing unmet need and feasibility for hearing- and balance-related indications
  • Leading the design and development of innovative clinical trials from translational stage through global Phase 3 trials and registration
  • Ownership of medical review and safety oversight for clinical trials
  • Developing and managing product profiles, Integrated Development Plans, and Clinical Development Plans
  • Piloting development of new non-audiometric diagnostic, prognostic, and monitoring tools for determining inner ear health and auditory/vestibular function (e.g., surrogate biomarkers, including imaging, non-audiometric electrophysiologic, behavioral/cognitive tasks, systemic biomarkers of ototoxicity)
  • Ownership of clinical sections of documents for regulatory submissions
  • Collaborating with the leaders of Clinical Operations, Program Management, Regulatory, and Business Development
  • KOL identification and relationship development
  • Developing data-mining strategy and plans for clinical hearing databases to generate a current understanding of the epidemiology and natural history of populations of interest, with a focus on determining elements that must be included in next-generation hearing registries that support drug development

 

Target Identification and Validation

  • Identifying and overseeing efforts to link the most promising preclinical biomarkers with clinically feasible outcome measures for both preclinical and clinical POC
  • Collaborating with the Computational Biology team to develop and mine novel integrated preclinical and clinical databases for target ID and validation
  • Providing the clinical and translational scientific filters required to accurately identify and prioritize novel targets

 

Other Activities

  • Preparing and presenting clinical trial data for internal and external advisory boards and scientific meetings
  • Leading, on behalf of the company, agreed-on strategic, collaborative foundation, government, academic, and/or public/private partnerships that enhance Decibel’s ability to contribute to and influence the field
  • Helping drive strategy and planning for studies, labeling, and target populations
  • Preparing and/or reviewing ancillary study documents (e.g., study guidelines, training materials)
  • Authoring and preparing Annual Reports/DSURs and Investigator Brochures
  • Identifying and vetting collaboration partners/stakeholders
  • Ensuring consistency in approaches and knowledge sharing throughout the organization, with the aim to ensure excellence in collaborative ventures with both our scientific and clinical partners
  • Working collaboratively with the Clinical team to develop Clinical COE brand positioning, key messages, and strategic imperatives

 

Requirements

  • MD PhD or MD with an international reputation and excellence in translational medicine
  • Demonstrated significant experience in authoring regulatory documents, submissions, and interactions with regulatory agencies across all development stages
  • Track record of building highly productive collaborative scientific relationships globally as reflected in peer-reviewed publications
  • Direct experience with the FDA in investigational new drug applications, new drug applications, and biologic license applications
  • Ability to understand novel complex domains and communicate key messages clearly
  • Strong writing and presentation skills
  • Excellent influencing skills
  • Ability to outperform both as a leader and as a team member, valuing collaborative culture over individual contribution
  • Willingness to “roll up the sleeves” to contribute to team efforts
  • At ease working with Executive Leadership, Board members, KOLs, regulatory bodies, and investors
  • Appetite for working in a small company with a highly matrixed style

 

Additional Desirable Experience

  • Strong background in medical genetics
  • Strong background in epidemiology/biostatistics
  • Background datamining and interpreting CNS or auditory systems biology databases
  • Deep understanding of biologic and genetic pathways relevant to CNS and/or hearing sciences

 

Travel

Travel is expected for this position, both domestic and international

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