Manager/Senior Manager, Clinical Research

Optinose US, Inc. Yardley , PA 19067

Posted 4 months ago

Primary Role / Job Purpose

The Manager/Senior Manager, Clinical Research oversees the direction, planning, execution, and interpretation of clinical trials research and data collection activities; steering coordination with clinical operations, reviewing and writing of clinical study reports and regulatory submission documents. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Supports new and ongoing clinical research and ensures efficient and timely processing of confidentiality agreements and clinical agreements. The incumbent is accountable for scientific aspects of global clinical development programs for Phases 1-4.

Key Responsibilities

  • Plan, design, and oversee Phases 1 through 4 clinical programs, primarily but not exclusively in Phase 3

  • Select and manage clinical vendors, including, but not limited to statistical services, medical writing, Key Opinion Leaders, consultants, and laboratories

  • Work with internal colleagues in steering scientific contributions for programs, protocols, IBs, and other clinical research projects

  • Serve as an active team member for IND and NDA submissions

  • Support program-wide quality assurance through various methods including sponsor monitoring and point of contact with QA department for auditing plans

  • Work with internal colleagues on creation of internal SOPs for clinical development; participating in training and periodic revisions

  • Work with internal colleagues on periodic safety review, including annual IB revisions

  • Oversee and challenge planning for study implementation

  • Work with medical and clinical colleagues to ensure coordination of data management, drug supply, clinical operations and drug safety

  • Participate and present at investigator meetings, ad hoc meetings, and various internal teams

  • Review literature and prepare summary documents for inclusion in IB, protocols, and regulatory submission documents

  • Participate in development planning for assigned compounds

  • Prepare/lead on preparation of key documents, including Investigator Brochures, regulatory submission documents, and internal or external presentations

  • Complete protocol preparation, including writing, reviewing, amending and steering cross-functional facilitation as appropriate

  • Clinical study report presentation

Qualifications

  • Graduate degree (PharmD or PhD) required in scientific or other relevant advanced degree

  • 3-4 years of clinical/scientific/research experience in the pharmaceutical industry and in academia, including a minimum of 2 years in clinical research related roles

  • Allergy, ENT, pulmonology and/or respiratory scientific/therapeutic knowledge/expertise a strong plus

  • Excellent written and verbal communication skills

  • Demonstrated experience in writing, reviewing and editing protocols and clinical study reports

  • Expert level knowledge of regulatory guidelines and FDA regulations for clinical research/trials

  • Proven track record and expertise with entire clinical research process, FDA, and other regulatory requirements that may impact clinical studies as well as ICH and GCP guidelines

  • Strong team effectiveness and collaboration skills; capability to prioritize and work effectively in a dynamic and cross-functional environment

  • Strong project management skills, including meeting project timelines and budgets

  • Required travel up to 20%, including domestic and international travel

  • Ability to review, comprehend, and discuss scientific literature in various therapeutic areas

  • Adept in initiating, developing, cultivating and maintaining relationships with external experts

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Manager/Senior Manager, Clinical Research

Optinose US, Inc.