Associate Director, TMF Operations

Cytokinetics; San Francisco (CA); Remote; USD 187.000 - 218.000; Vollzeit

Benefits dieser Stelle

Equity (stock options/RSUs)

Health, dental, vision, life and disa​

401(k) with employer match

Learning stipend

Wellness stipend

Paid time off

Zusammenfassung

Cytokinetics is seeking a Director of TMF Operations to lead transformation and ongoing TMF governance for inspection-ready processes across studies and vendors. The role partners with Clinical Operations, Quality/Compliance, Regulatory, IT, and Procurement to embed TMF into core clinical processes.

You will drive risk-based oversight, KPIs, and dashboards, while managing CROs and ensuring compliance with ICH-GCP and TMF Reference Model.

Qualifikationen

• Bachelor-level degree required; advanced degree highly desirable.
• Significant TMF/eTMF leadership experience for Associate Director level.
• Deep expertise in TMF strategy, governance, inspection readiness, and health authority inspections (FDA/EMA).
• Extensive experience with eTMF systems and vendor management.

Aufgaben

• Lead the TMF operating model: strategy, governance, standards and operating model.
• Define TMF processes, KPIs, and risk-based oversight for consistency and compliance.
• Oversee TMF across programs ensuring alignment with ICH-GCP and TMF Reference Model.
• Lead TMF oversight in outsourced models; drive CRO/vendor accountability and dashboards.
• Establish health metrics, risk indicators, and escalation pathways across studies.
• Act as TMF SME, guide cross-functional teams, and support sponsor/CRO training.
• Lead TMF-related inspections readiness and responses (FDA/EMA) and QA audits.
• Drive TMF system strategy and governance across eTMF/CTMS/eDC/regulatory/QMS.
• Lead or support migrations, system implementations, and vendor transitions.

Kenntnisse

TMF leadership

Regulatory inspections

Cross-functional leadership

CRO/vendor management

Project management

ICH-GCP knowledge

eTMF systems

Veeva Vault TMF

Ausbildung

BS/BA degree

Advanced degree

Tools

Veeva Vault TMF

Jobbeschreibung

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 portfolioDefine 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 oversightOversee TMF across all programs, ensuring alignment with ICH-GCP, TMF Reference Model, and global regulatory expectationsLead TMF oversight in an outsourced model, driving CRO/vendor accountability for TMF completeness, quality, and timeliness, including dashboards and governance reporting to senior leadershipEstablish and drive TMF health metrics, risk indicators, and escalation pathways across studiesServe 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 governanceLead 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 programServe as TMF lead/SME for TMF-related inspections and QA audit activitiesDrive TMF inspection preparation, SME briefing, document retrieval, and response coordination including TMF demonstrations, evidence packages and remediation planningLead or support remediation and CAPA development for TMF-related inspection findingsDrive eTMF system strategy and governance, including:System configuration, taxonomy, and metadata standardsLead cross system TMF artifact mapping and reconciliation across eTMF, CTMS, eDC, safety, regulatory and QMS to support trial reconstructionVendor/system performance and optimizationPartner with IT and quality systems on validation and change control for eTMF and related systems, as applicableOversight of enhancements, releases, and UATDrive TMF quality at scale by:Establishing QC/QR frameworks and oversight modelsDriving effective TMF reconciliation practices across functions and vendorsIdentifying systemic gaps and implementing continuous improvement initiativesProvide leadership and oversight to TMF staff and/or vendors, including mentoring and capability buildingPartner cross-functionally with Clinical Operations, Study Teams, QA, Regulatory, and external partners to drive end-to-end TMF alignmentLead and support TMF-related risk management, including proactive identification and mitigation of compliance risksLead or support TMF migrations, system implementations, and vendor transitionsPartner 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 desirable6-8 years of clinical research experience, including significant TMF/eTMF leadership experience for Associate Director levelProven experience in building and leading TMF frameworks in an outsourced or hybrid operating modelDeep expertise in TMF strategy, governance, inspection readiness, and health authority inspections (FDA, EMA)Strong knowledge of ICH-GCP, TMF Reference Model, and global regulatory requirementsExtensive experience with eTMF systems (e.g., Veeva Vault TMF or equivalent), including system governance and optimizationExperience managing CROs/vendors and holding them accountable for TMF quality and deliveryExcellent communication and ability to represent TMF in regulatory-facing settingsDemonstrated excellence in complex project management and effective management of multiple projects/prioritiesMust 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 levelStrong leadership, strategic thinking, and decision-making skillsWork Environment:Dynamic, interactive, fast-paced, and entrepreneurial environmentThe position is for remote workDomestic travel required (up to 10%)#LI-HYBRIDPay Range:The salary range for this position is:South San Francisco, California: $186,750-$217,875Radnor: $172,800-$201,600The 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 OffersRecently, 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 applicationsWe will never request personal information such as banking details until after an official offer has been accepted and verifiedWe will never request that you purchase equipment or other items when interviewing or hiringIf you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at [e-mail] visit our website at: www.cytokinetics.comCytokinetics is an Equal Opportunity Employer