Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.
Reporting to the Head of Operational Excellence, the Director, TMF Operations leads Cytokinetics TMF transformation and ongoing TMF operations to deliver a governed, inspection-ready TMF operating model. The role will drive TMF strategy, quality, oversight, and inspection readiness, including TMF governance, a harmonized Sponsor TMF definition across systems and partners, and a CRO model that demonstrates sponsor oversight. The Director drives the shift to process-centric TMF management by embedding TMF outputs into core clinical processes, implementing risk-based oversight, and delivering KPIs and dashboards for completeness, timeliness, and risk.
This role partners with Clinical Operations, Clinical Research, Quality/Compliance, Regulatory, CMC, IT, and Procurement/Legal to ensure compliant processes, systems, training, and documentation.
Key Responsibilities:
- Lead the TMF operating model, including strategy, governance, standards, and operating model to support portfolio
- Define and implement TMF processes, standards, and KPIs to promote consistency, quality, and compliance across studies and vendors utilizing a risk-based approach to ensure sponsor oversight
- Oversee TMF across all programs, ensuring alignment with ICH-GCP, TMF Reference Model, and global regulatory expectations
- Lead TMF oversight in an outsourced model, driving CRO/vendor accountability for TMF completeness, quality, and timeliness, including dashboards and governance reporting to senior leadership
- Establish and drive TMF health metrics, risk indicators, and escalation pathways across studies
- Serve as the TMF subject matter expert, guiding cross-functional teams, influencing best practices, supporting role-based training for sponsor and CRO teams, and monitoring adoption and uptake through metrics and governance
- Lead and support TMF-related activities for health authority inspections (FDA, EMA, and other regulatory agencies)
- Drive continuous inspection readiness by defining, implementing and improving the TMF/eTMF operating model and performance program
- Serve as TMF lead/SME for TMF-related inspections and QA audit activities
- Drive TMF inspection preparation, SME briefing, document retrieval, and response coordination including TMF demonstrations, evidence packages and remediation planning
- Lead or support remediation and CAPA development for TMF-related inspection findings
- Drive eTMF system strategy and governance, including:
- System configuration, taxonomy, and metadata standards
- Lead cross system TMF artifact mapping and reconciliation across eTMF, CTMS, eDC, safety, regulatory and QMS to support trial reconstruction
- Vendor/system performance and optimization
- Partner with IT and quality systems on validation and change control for eTMF and related systems, as applicable
- Oversight of enhancements, releases, and UAT
- Drive TMF quality at scale by:
- Establishing QC/QR frameworks and oversight models
- Driving effective TMF reconciliation practices across functions and vendors
- Identifying systemic gaps and implementing continuous improvement initiatives
- Provide leadership and oversight to TMF staff and/or vendors, including mentoring and capability building
- Partner cross-functionally with Clinical Operations, Study Teams, QA, Regulatory, and external partners to drive end-to-end TMF alignment
- Lead and support TMF-related risk management, including proactive identification and mitigation of compliance risks
- Lead or support TMF migrations, system implementations, and vendor transitions
- Partner with Procurement/Legal to embed TMF expectations in contracts and SOWs (access, reporting, audit rights, inspection support)
Requirements:
- BS/BA degree required, advanced degree highly desirable
- 6-8 years of clinical research experience, including significant TMF/eTMF leadership experience for Associate Director level
- Proven experience in building and leading TMF frameworks in an outsourced or hybrid operating model
- Deep expertise in TMF strategy, governance, inspection readiness, and health authority inspections (FDA, EMA)
- Strong knowledge of ICH-GCP, TMF Reference Model, and global regulatory requirements
- Extensive experience with eTMF systems (e.g., Veeva Vault TMF or equivalent), including system governance and optimization
- Experience managing CROs/vendors and holding them accountable for TMF quality and delivery
- Excellent communication and ability to represent TMF in regulatory-facing settings
- Demonstrated excellence in complex project management and effective management of multiple projects/priorities
- Must have demonstrated ability to solve problems with innovative solutions along with strong organizational skills.
- Demonstrated ability to lead cross-functional initiatives and influence at a senior level
- Strong leadership, strategic thinking, and decision-making skills
Work Environment:
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic travel required (up to 10%)
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Pay Range:
The salary range for this position is:
South San Francisco, California: $186,750-$217,875
Radnor: $172,800-$201,600
The base pay offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Base salary is just one component of our competitive total compensation package, which includes equity in the form of stock options and/or restricted stock units, comprehensive health, dental, vision, life and disability insurance coverage, 401k retirement benefits with employer match, learning and wellness stipends, and paid time off. Note that benefits are subject to change and may vary based on jurisdiction of employment.
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
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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
