Director/Senior Director, Clinical Science

Akouos

Boston, MA, US
  • Job Type: Full-Time
  • Function: Clinical Research
  • Post Date: 05/04/2021
  • Website: akouos.com
  • Company Address: 645 Summer St, suite 200, Boston, MA

About Akouos

Akouos is a biotechnology company focused on restoring and preserving hearing.

Job Description

Akouos is building a leading gene therapy company focused on hearing disorders. We are a precision genetic medicine company focused on developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals who live with disabling hearing loss worldwide.

Restoring, improving, and preserving high-acuity hearing is an area of high unmet need in medicine: 466 million people worldwide have disabling hearing loss, and there are no FDA-approved pharmacologic therapies to address its underlying causes.

Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy. Listening is in our DNA. We believe the only way to achieve our ambitious goals is to engage as one team, listen to each other, and trust in ourselves and our science.

Job Summary:

The Director/Senior Director Clinical Science is a senior leader and experienced clinical trialist responsible for the clinical and scientific execution of global clinical programs. S/he will play a key role in defining development strategy (including production of the target product profile and clinical development plan) and will ensure timely planning, implementation, managing, and reporting of clinical studies and trials. S/he will collaborate cross-functionally to apply clinical learnings across all clinical programs as needed and will provide insight into clinical development programs both externally and internally (e.g., Medical Affairs, Commercial, CROs, etc.). S/he will provide clinical / scientific support for business development activities by evaluating potential new product and partnerships.

Job Responsibilities:

  • Assists in defining global clinical strategy, based on medical need and development requirements; adapts as necessary to evolving conditions.
  • Serves as the clinical / scientific lead for the clinical trial / program; accountable for the clinical / scientific execution of clinical protocol(s) / programs (including interventional, non-interventional, validation, natural history, and registry trials / studies).
  • Supports the clinical operations team, including clinical trial manager, in achieving study deliverables, including adherence to budget and timelines.
  • Lead for scientific aspects of the implementation and conduct of clinical studies and trials (g., scientific advisory committees, data safety monitoring boards, medical monitoring)
  • Guides the evaluation of emerging clinical trial data and oversees data interpretation; supports Medical Affairs in publication of data and development of materials (g., slide decks, posters, manuscripts, abstracts, etc.) based on clinical trial data.
  • Supports authorship and review of clinical / regulatory documents (g., protocols, Investigator Brochures, clinical study reports, briefing packages, etc.); collaborates cross-functionally in planning regulatory strategy and communications.
  • Serves as primary clinical representative on internal and external teams; participates in development, review, and / or presentation of clinical data in internal and external meetings, as needed (g., DSMB, training, Investigator meetings, Board presentations, etc.).
  • Develops professional relationships with external clinical opinion leaders, investigators, consultants, advocacy groups, and others. Works closely with these experts to design, develop, and advance clinical programs.
  • Builds talent and capabilities of junior team members through proactive coaching, mentoring, and identification of development opportunities. May include management of direct reports.
  • Other duties as assigned or as business needs require.

Job Qualifications:

  • Degree in the Life Sciences required.
  • Generally, has 10+ years of pharmaceutical and/or clinical experience, with global experience preferred.
  • Prior pharma / biotech or academic experience in rare disease, otology, audiology, conducting clinical research, gene therapy, cellular therapy, biologics a plus.
  • Proven track record of successfully conducting clinical trials and regulatory interactions and approvals.
  • Comprehensive understanding of the drug development and approval process and clinical trial design.
  • Strong interpersonal and leadership skills required.
  • Strong analytical and problem-solving skills, including the ability to identify and evaluate the critical issues of problems or opportunities; given background, experience, and judgment, able to understand potential causes and deliver potential solutions.
  • Ability to plan and think strategically and critically; intellectually curious, willing to take ownership of the assigned clinical programs.
  • Ability to critically evaluate and analyze scientific data and literature.
  • Strong communication skills (written and verbal) including the ability to express oneself clearly and concisely, and to message and document key progress and challenges appropriately; excellent presentation skills required.
  • Knowledgeable in budget and finance processes appropriate to the pharmaceutical industry
  • Capable of representing Akouos professionally with external global opinion leaders, investigators, vendors, regulatory agencies, and others.
  • Ability to work effectively cross-functionally, and to serve as clinical resource within the company.
  • Self-motivated and detail-oriented with ability to prioritize and handle multiple projects.

 

Akouos is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.