Associate Director, TMF Operations

Cytokinetics•Radnor, CA

2d•Remote

About The Position

Cytokinetics is a specialty cardiovascular biopharmaceutical company focused on muscle biology and developing potential medicines for diseases of cardiac muscle dysfunction. The Associate Director, TMF Operations leads TMF transformation and ongoing operations to deliver a governed, inspection-ready TMF operating model. The role drives TMF strategy, quality, oversight, and inspection readiness, including governance, a harmonized Sponsor TMF definition across systems and partners, and sponsor oversight of CROs. It advances process-centric TMF management by embedding TMF outputs into core clinical processes, implementing risk-based oversight, and developing KPIs and dashboards for completeness, timeliness, and risk. The position partners with Clinical Operations, Clinical Research, Quality/Compliance, Regulatory, CMC, IT, Procurement, Legal, and external partners to ensure compliant processes, systems, training, and documentation. It leads TMF governance and operating standards across the portfolio; oversees TMF quality, reconciliation, metrics, and risk management; and supports health authority inspections, audits, remediation, and CAPAs. It also drives eTMF system strategy and governance, including configuration, taxonomy, metadata, cross-system artifact mapping, validation, change control, enhancements, releases, and UAT. The role provides leadership and capability building for TMF staff and vendors and supports migrations, implementations, and vendor transitions. The work environment is described as dynamic, interactive, fast-paced, and entrepreneurial. The position is remote, with domestic travel required up to 10%. The advertised base salary ranges are $186,750–$217,875 in South San Francisco, California, and $172,800–$201,600 in Radnor. Compensation may vary based on factors including geographic region, knowledge, skills, and experience. The total compensation package includes equity in the form of stock options and/or restricted stock units, insurance coverage, 401(k) retirement benefits with employer match, learning and wellness stipends, and paid time off; benefits may vary by jurisdiction and are subject to change.

Requirements

BS/BA degree required.
6–8 years of clinical research experience, including significant TMF/eTMF leadership experience for the Associate Director level.
Proven experience building and leading TMF frameworks in an outsourced or hybrid operating model.
Deep expertise in TMF strategy, governance, inspection readiness, and health authority inspections, including FDA and EMA.
Strong knowledge of ICH-GCP, the TMF Reference Model, and global regulatory requirements.
Extensive experience with eTMF systems, such as 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 skills and ability to represent TMF in regulatory-facing settings.
Demonstrated excellence in complex project management and effective management of multiple projects and priorities.
Demonstrated ability to solve problems with innovative solutions and strong organizational skills.
Demonstrated ability to lead cross-functional initiatives and influence at a senior level.
Strong leadership, strategic thinking, and decision-making skills.

Nice To Haves

Advanced degree is highly desirable.

Responsibilities

Lead the TMF operating model, including strategy, governance, standards, and portfolio-supporting operations.
Define and implement TMF processes, standards, and KPIs to promote consistency, quality, compliance, and risk-based sponsor oversight across studies and vendors.
Oversee TMF across programs to ensure alignment with ICH-GCP, the TMF Reference Model, and global regulatory expectations.
Lead TMF oversight in an outsourced model and drive 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, guide cross-functional teams, influence best practices, support role-based sponsor and CRO training, and monitor adoption through metrics and governance.
Lead and support TMF activities for health authority inspections, including 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 or SME for TMF-related inspections and QA audit activities.
Drive inspection preparation, SME briefings, document retrieval, response coordination, 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 systems to support trial reconstruction.
Oversee vendor and system performance and optimization.
Partner with IT and quality systems on validation and change control for eTMF and related systems, as applicable; oversee enhancements, releases, and UAT.
Establish QC/QR frameworks and oversight models, drive effective TMF reconciliation across functions and vendors, and identify systemic gaps and 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 and Legal to embed TMF expectations in contracts and SOWs, including access, reporting, audit rights, and inspection support.