Careers

Director/Senior Director Clinical Development

CAMBRIDGE, MA

About Aura:

At Aura Biosciences, we are developing a new class of therapies to target and destroy cancer cells selectively, while leaving surrounding tissue unharmed – an approach we call molecular surgery.  By safely eliminating cancer locally, we can treat early and transform the lives of people with a wide range of cancers that are poorly managed today.

Our lead program in ocular melanoma is designed to remove cancer cells in the back of the eye as a first-line therapy potentially long before the disease progresses and metastasizes to the liver, where it almost always is fatal. Development of a first-in-class treatment option to selectively destroy cancer cells would create the possibility of a cure in this and other cancers where the disease can be detected early.

Position Summary:

Aura Biosciences is actively recruiting for a Director/Senior Director Clinical Development.  The successful candidate will have significant experience in ophthalmology R&D, be a critical member of the R&D leadership team, work in partnership with the Executive Medical Director to lead Aura’s clinical development pipeline and be a key contributor to the Company’s drug development programs.

 The candidate will perform various duties including helping to set the strategic direction for clinical development, generating and reviewing key data/results and clinical documents, and representing the company in investigator meetings and key relationships in the field

Essential Functions

To perform this job successfully, the individual must be able to:

  • Be responsible for all areas of clinical affairs including clinical trial strategy and design, preparation of the clinical development plan, and contribution to regulatory strategy

  • Collaborate closely with Clinical Operations colleagues on clinical trial activities, including oversight of CROs, consultants, clinical investigators, and vendor management

  • Stay current with GCP and regulatory requirements in the preparation and review of the clinical submission in the US and EU.

  • Manage relationships with KOLs and communicate clinical strategy to investors; manage data monitoring committees

  • Obtain key stakeholder review and endorsement of clinical and medical aspects of all development programs

  • Interface with preclinical research and development leadership in the evaluation and analysis of product opportunities

  • Develop clear clinical trial strategies, lead the design and authorship of trial protocols, conduct ongoing review of clinical trial safety and efficacy data and interpret clinical trial results.

  • Author/contribute to other clinical documents such as IB and clinical sections of Integrated Development Plan.

  • Be responsible for preparation of clinical sections of regulatory documents (INDs, IND annual reports, briefing packages, etc.); collaboratively prepare for meetings with FDA/EMA

  • Interface with key therapeutic experts and Aura staff to provide subject matter expertise on clinical strategic initiatives, including competitive and complementary products, technologies and companies

  • Manage the clinical development budget, along with Clinical Operations leadership

  • Be part of the Clinical Leadership Team along with the Executive Medical Director and the Senior Director, Clinical Operations.

Qualifications

The ideal candidate will offer:

  • M.D, PhD or PharmD with at least 3 years of experience leading Clinical Development

  • Ophthalmology pharmaceutical experience required and ophthalmic device experience and/or  oncology therapeutic experience a plus

  • 5-10 years of full-time industry experience in drug development preferred; direct experience managing, planning, organizing, implementing, and completing phase I-III clinical trials

  • Experience working with small companies in the start-up environment is a strong plus

  • This person will ‘own’ clinical development and have a ‘role up your sleeves and get it done’ approach that is critical in biotech

Location:

Based in the Company’s North Cambridge office, with <20% travel required.

How we Work:

Aura is powered by a passion for bringing together diverse people, ideas and technologies behind common purpose: to create breakthroughs in diseases with significant unmet medical needs.  We constantly seek opportunities to broaden our impact and reach, using new platforms and technologies, and partnering to ensure that our drug development expertise reaches its full therapeutic potential.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.

Interested?

Email a cover letter and a copy of your CV to HR@aurabiosciences.com referencing the position description in the subject line.

Apply