Ruderfer & Associates
Biopharmaceutical Search Consultants

#2098

Clinical Trial Disclosure & Transparency, Associate Director/Director

Position:                    Clinical Trial Disclosure & Transparency, Associate Director/Director     Job #2098

Location:                    Southern NY

Compensation:          Based Upon Experience

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Job Summary:

The Associate Director / Director of Clinical Trial Disclosure and Transparency is responsible for leading and managing global Clinical Trial Disclosure and Data Transparency activities. This role will serve as a subject matter expert and primary point of contact for transparency and disclosure activities. The Director will partner with and lead interactions with senior management in relevant functional areas, and manage staff who are directly involved in activities related to disclosure and transparency. Oversight of clinical trial registry activities, lay language results summaries and clinical data sharing may also be in scope.

Duties & Responsibilities:

  • Serves as a subject matter expert and advisor on international clinical trial disclosure strategies

  • Support strategic Disclosure and Transparency initiatives with internal core team and cross functionally

  • Interprets rapidly changing domestic and international laws and requirements for clinical trial results disclosure to maintain compliance

  • Ability to anticipate and identify areas of change, assess potential impact, propose strategic adaptability, and lead and oversee change management efforts

  • Manages redaction of clinical trial documents for EMA Policies and Clinical Registry results postings

  • Ensures disclosures and transparency activities are performed on time and with the highest of standards

  • Works with internal core team to drive development and implementation of processes, standards, and training material for Disclosure and Transparency activities

 Qualifications:

  • Bachelor's degree (advanced degree preferred) in science or a health profession experience

  • Eight+ years in the biotechnology/pharmaceutical industry; experience in Clinical Science, Clinical Operations, or Medical Writing preferred

  • Demonstrated understanding of global regulatory requirements and other policies (eg, ICMJE) related to clinical trial disclosure

  • Understands the clinical drug development process, including clinical trial design, operations and results analysis

  • Strong leadership, planning, and project management skills, along with initiative and ability to be productive with minimal supervision and minimal administrative support

  • Outstanding oral and written communication skills

  • Flexible; adapts work style to meet organization needs

  • Has well-developed computer skills including proficiency in MS Office, Adobe, and Regulatory Document Management Systems

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