Associate Director, Clinical Trial Transparency

Role Summary

The Associate Director, Clinical Trial Transparency (CTT) will be responsible for supporting and overseeing all aspects of CTT at Cytokinetics, working in partnership with Regulatory Strategy, Medical Writing, and functional area subject matter experts (SMEs). This individual will lead development of or contribute to several CTT deliverables including but not limited to: Clinicaltrials.gov postings, EU Clinical Trials Information System (CTIS) postings, other clinical trial registry postings, plain language summaries, and redaction packages for submission and publication. In addition, the Associate Director, CTT will play a key role in assessing Cytokinetics processes and standards for developing CTT-related content, working in close partnership with Medical Writing and other functions.

Responsibilities

• Participate in and/or lead development of clinical trial registry postings to registries/databases including: Clinicaltrials.gov, EU CTIS, and other local/regional clinical trial registries
• Oversee activities related to preparation of redacted information to be submitted to health authorities and published to clinical trial registries, including but not limited to EMA Policy 0070 packages, EU CTIS redacted document postings, and other CTT-related redacted document packages needed
• Manage development of clinical trial plain language summary documents, in conjunction with Medical Writing and SMEs, as needed
• Manage vendors and/or consultants supporting development of CTT-related documents/postings
• Develop and manage consistent, clear timelines for authoring, review, and approval of CTT-related items, and ensure stakeholders are adequately informed of responsibilities and status of each deliverable in a timely manner
• Proactively escalate potential timeline and/or content issues to management and/or appropriate functions within Cytokinetics
• Lead and participate in CTT-related process development initiatives at Cytokinetics including but not limited to: SOP development, project tracker development/maintenance, best practice development
• Participate in Regulatory Affairs-specific and cross-functional initiatives related to CTT (e.g., EU CTR/CTIS process development)
• Proactively monitor new and emerging CTT regulations and guidelines, providing clear and concise updates to impacted Cytokinetics functions including Regulatory Affairs, and Research and Development functions

Qualifications

• BA or BS in a life sciences-related discipline with a minimum of 9 years of combined experience relevant to CTT
• Ability to work both independently and in cross-functional team environments with minimal supervision
• Strong written and verbal communication skills. Ability to engage and disseminate information among appropriate stakeholders for effective development of CTT-related materials
• Demonstrated ability to lead development of CTT-related deliverables. This includes excellent project-related written and verbal skills, timeline management, and issue identification/escalation
• Ability to manage consultants/contractors
• Demonstrated success in working cross-functionally and within a department on process initiatives including; Process development, SOP development, and initiatives related to new and emerging regulations/guidelines
• Deep knowledge of CTT-related regulations and guidelines related to Clinicaltrials.gov, EU CTR, EMA Policy 0070, etc.
• Ability to interpret and assess impacts of new and emerging regulations and guidelines
• Attention to detail with an ability to detect errors and inconsistencies in various types of documents