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Visterra, Inc.
Waltham, Massachusetts, United States
14 days ago
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Visterra, Inc.
Waltham, Massachusetts, United States
14 days ago

Description

Visterra is a clinical stage biotechnology company committed to developing innova­tive biologic therapies (monoclonal antibodies and therapeutic muteins) for the treatment of kidney diseases, with an immuno-nephrology focus in drug development. Our proprietary technology platform enables the design and engineering of precision antibody or protein-based drug candidates to modulate key disease targets. We are de­veloping a robust pipeline of novel therapies for patients with unmet needs.

Visterra is a wholly owned subsidiary of Otsuka America, Inc., which is a U.S. holding company subsidiary of Otsuka Pharmaceutical Co., Ltd. of Japan.  Visterra has approximately 85 employees, and is located in Waltham, Massachusetts.

Summary

The Associate Director, Clinical Development will report to the Vice President, Translational Medicine and will independently lead clinical development of our novel biological candidates with an emphasis on nephrology and immunology/rheumatology indications. This is a full-time position located at Visterra’s facility in Waltham, MA.

Responsibilities

  • In matrix environment, provide leadership and medical and basic science insight to clinical development group functions including clinical operations, biostatistics and clinical pharmacology.
  • Develop, write and execute clinical development plans and protocols from phase 1 through 3.
  • Work with regulatory personnel to develop strategy and file necessary documentation.
  • Collaborate with clinical operations team and CROs to successfully execute studies, including regular interactions with and support for clinical trial site investigators and coordinators.
  • Integrate pharmacokinetics, biomarkers, pharmacogenetics and pharmacogenomics, biostatistics and regulatory strategy into clinical development plans with appropriate cross-disciplinary support.
  • Supervise and be accountable for the production of clinical study reports.
  • Provide guidance for clinical data organization and interpretation.
  • Monitor clinical trials for safety and, when appropriate, efficacy.
  • Assist in the development of case report forms used to capture data from clinical protocols.
  • Identify clinical investigators and coordinate their activities in the conduct of clinical trials and advisory board meetings.
  • Assist in the identification and relationship management with key opinion leaders serving Visterra as clinical trial investigators or through their participation in consulting relationships or scientific advisory board membership.
  • Manage the preparation of data presentations for manuscripts, and congress presentations.
  • Present clinical trial data and development plans to senior management team.


Requirements

Requirements

  • Medical degree (MD, DO) with Nephrology or Rheumatology Board Certification.
  • Candidates who are completing or have recently completed fellowship training welcome.
  • Additional clinical research or statistics training reflected in M.S. or M.P.H. degree desirable, but not a prerequisite.
  • Ideal candidates will have firm grasp of immunopathologic renal disease or basic immunology expertise.
  • Excellent interpersonal, oral and written communication skills. 
  • Strong organizational skills, attention to accuracy and detail, and the ability and willingness to multi-task as needed.
  • Limited travel (< 5%) may be required to attend conferences and industry events.

Visterra provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Job Information

  • Job ID: 59439155
  • Location:
    Waltham, Massachusetts, United States
  • Position Title: Associate Director, Clinical Development
  • Company Name: Visterra, Inc.
  • Job Function: Clinical,
    Drug Development,
    Immunology
  • Job Type: Full-Time
  • Job Duration: Indefinite
  • Min Education: Ph.D.
  • Min Experience: 0-1 Year
  • Required Travel: 0-10%

Please refer to the company's website or job descriptions to learn more about them.

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