Associate Director, Clinical Trial Transparency

Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.

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
  
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Pay Range:

Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.

Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.  

Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.

Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers

Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.

Here are some ways to check for authenticity:

• We do not conduct job interviews through non-standard text messaging applications

• We will never request personal information such as banking details until after an official offer has been accepted and verified

• We will never request that you purchase equipment or other items when interviewing or hiring

• If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer