Senior Director, Regional Pharmacy Operations

Posted 14 Hours Ago
Be an Early Applicant
Hiring Remotely in United States
Remote
220K-230K Annually
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
Provides enterprise leadership for pharmacy operations across START’s U.S. clinical research sites. Responsibilities include standardizing investigational drug services, sterile compounding, clinical documentation, procurement, compliance, quality systems, KPIs, technology strategy, audits, and site launches. The role develops pharmacy leaders, manages budgets and change initiatives, ensures regulatory and GCP readiness, and serves as a subject-matter expert in investigational drug management for early-phase oncology trials.
Summary Generated by Built In

The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering "Hope Through Access” to cutting edge trials throughout the United States and Europe.   

  

We are seeking a Sr. Director, Regional Pharmacy Operations. The Sr. Director of Regional Pharmacy Operations provides executive leadership and strategic oversight of pharmacy services across all START USA sites, including Investigational Drug Sections (IDS), clinical pharmacy operations, and compliance with regulatory requirements. This role is accountable for developing and executing operational strategies, standardizing processes, and ensuring regulatory readiness and excellence in clinical trial drug handling and patient care. The Sr. Director is a seasoned pharmacy leader with deep expertise in investigational drug management, sterile compounding, and clinical trial pharmacy operations.

The successful candidate will bring a strong background in pharmacy regulations, quality improvement, operational efficiency, and people leadership. This role is pivotal in shaping the future direction of START’s pharmacy services and ensuring sustainable growth and excellence in oncology research.

The Sr. Director serves as both an operational leader and a strategic architect — driving continuous improvement as an enterprise operating philosophy, building infrastructure and systems that scale with organizational growth, and positioning pharmacy operations as a growth enabler for the business. This role demands the ability to lead with clarity and cohesion across geographically distributed sites, balancing the urgency of growth with the non-negotiable boundaries of patient safety and regulatory compliance.

A primary and critical success factor for this role is the degree to which the Sr. Director actively partners with peer regional pharmacy leaders to achieve and maintain complete consistency in pharmacy operations, metrics, and standards across all START regions — now two regions, and potentially expanding to three or four — except where local regulatory or legal requirements necessitate documented variation. 

The annual base salary for this remote role is $220,000 - $230,000. However, base pay may vary depending on multiple individualized factors including market location, job-related knowledge, skills, and experience. 

  

Work Schedule:  Monday - Friday

  

Essential Responsibilities: 

  •   Provide enterprise-wide pharmacy leadership across all START USA sites, ensuring consistent, compliant, and high-quality pharmacy operations.
  • Partner closely with the executive team, site leadership, and clinical operations to align pharmacy strategy with organizational goals.
  • Lead the design, implementation, and continuous improvement of standardized pharmacy workflows, including investigational drug accountability, sterile compounding, and clinical documentation.
  • Monitor and ensure compliance with federal and state regulatory requirements (e.g., FDA, USP <797>/<800>, DEA, State Boards of Pharmacy) and Good Clinical Practice (GCP) standards.
  • Align drug procurement workflows, in partnership with affiliate practices/hospitals to ensure streamlined effort and reduced cost.
  • Establish pharmacy-specific KPIs and dashboards to monitor operational performance and identify areas for efficiency gains.
  • Mentor and develop pharmacy leadership at each site, creating a strong bench of talent and fostering a high-performing, service-oriented culture.
  • Lead large-scale change management initiatives, including integration of new sites, implementation of new technology platforms, and regulatory readiness audits.
  • Maintain strong relationships with external regulatory bodies, vendors, partner practices, sponsors, and audit teams as needed.
  • Oversee pharmacy-related planning for new protocol activation, site launches, and volume forecasting.
  • Serve as a senior subject matter expert on investigational drug management in early-phase oncology trials.

Required Education and Experience: 

  • Graduate of an ACPE-accredited School of Pharmacy (PharmD or equivalent).
  • Active and unrestricted State Pharmacist License.
  • 10+ years of progressive pharmacy leadership experience, including direct oversight of investigational pharmacy operations.
  • Deep knowledge of investigational drug services, clinical trial protocols, and regulatory standards.
  • Demonstrated success in leading multi-site pharmacy operations or healthcare systems.
  • Proven ability to lead people, drive strategic initiatives, and manage organizational change.
  • Familiarity with pharmacy automation systems, EMR platforms, and drug accountability technologies.
  • Proficiency in sterile compounding practices, hazardous drug handling (USP <797>/<800>), and chemotherapy preparation.
  • Advanced understanding of GCP, ICH, and regulatory inspection readiness.
  • Proven experience applying continuous improvement methodologies (Lean, Six Sigma, or equivalent) in pharmacy or clinical operations environments, with demonstrated measurable outcomes.
  • Experience owning or co-owning a pharmacy quality management system, including SOP governance, deviation management, and CAPA program oversight.
  • Demonstrated financial accountability, including budget ownership, variance management, and business case development for operational or capital investments.
  • Experience leading pharmacy technology strategy, including evaluation, implementation, and optimization of automation systems, drug accountability platforms, or EMR integrations.
  • Competency in data analytics and operational reporting, including KPI framework development, dashboard design, and translating data into operational decisions.
  • Knowledge of investigational product supply chain management, including cold chain integrity, chain of custody compliance, and drug logistics in a regulated environment.

Preferred Education and Experience: 

  • Board Certification in Oncology Pharmacy (BCOP).
  • Completion of a PGY2 residency in oncology or health-system administration.
  • Lean Six Sigma or other process improvement certification.
  • Experience in supporting early-phase oncology research and regulatory audits (FDA, EMA, sponsor).
  • Lean Six Sigma Green Belt or Black Belt certification.
  • Experience building or leading pharmacist residency or academic pipeline development programs.
  • Demonstrated experience in regulatory horizon scanning and proactive compliance adaptation across multiple jurisdictions.
  • Experience with cross-regional pharmacy governance in a distributed CRO, health-system, or pharmaceutical manufacturing network.

  Physical and Travel Requirements:

  • 60–80% of time may be spent walking, standing, or moving between clinical areas.
  • Ability to lift up to 25 pounds.
  • Travel expected up to 25-50%, including visits to START USA sites and participation in leadership or audit meetings.

Best-in-Class Benefits and Perks  

We value the time, talent, and dedication our employees bring to START. Our commitment to your well-being and growth is reflected in a competitive compensation package—based on experience—along with comprehensive benefits designed to support you both personally and professionally:  

  

  • 401(k) retirement savings plan with employer match  
  • Eligibility for an annual performance bonus, based on role and company results  
  • Generous paid time off and paid holidays  
  • Comprehensive medical, dental, and vision coverage and optional insurance options  
  • Company paid life and disability insurance for added financial protection  
  • Employee Assistance Program (EAP) providing confidential, no ‑cost support for you and your family from day one  
  • Flexible FSA and HSA plans to support your financial wellness  
  • Commitment to a supportive environment that values balance, wellbeing, and flexibility  
  • We’re committed to fostering a collaborative, creative workplace where every team member is encouraged to contribute. At START, you’ll join a team that values continuous learning, professional growth, shared ideas, and a culture built on inclusivity and innovation.  

  

More About START  

START clinical trial sites have conducted more than 1,000 early-phase clinical trials, including dozens of therapies that were approved by the FDA or EMA. START represents the world’s largest roster of early-phase principal investigators across its Network of clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world via our mission of “Hope Through Access”. 

  

Learn more at STARTresearch.com.   

  

Ready to be part of a team changing the future of cancer treatment?  

Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online.  

  

We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.  

  



Skills Required

  • Graduate of an ACPE-accredited School of Pharmacy with a PharmD or equivalent
  • Active and unrestricted state pharmacist license
  • 10 or more years of progressive pharmacy leadership experience, including direct oversight of investigational pharmacy operations
  • Deep knowledge of investigational drug services, clinical trial protocols, and regulatory standards
  • Experience leading multi-site pharmacy operations or healthcare systems
  • Experience leading people, strategic initiatives, and organizational change
  • Familiarity with pharmacy automation systems, EMR platforms, and drug accountability technologies
  • Proficiency in sterile compounding, hazardous drug handling under USP 797 and USP 800, and chemotherapy preparation
  • Advanced understanding of GCP, ICH, and regulatory inspection readiness
  • Experience applying Lean, Six Sigma, or equivalent continuous improvement methodologies with measurable outcomes
  • Experience owning or co-owning a pharmacy quality management system, including SOP governance, deviation management, and CAPA oversight
  • Financial accountability including budget ownership, variance management, and business case development
  • Experience leading pharmacy technology strategy, including automation, drug accountability platforms, or EMR integrations
  • Competency in data analytics, operational reporting, KPI frameworks, and dashboard design
  • Knowledge of investigational product supply chain management, cold chain integrity, chain of custody, and regulated drug logistics
  • Board Certification in Oncology Pharmacy (BCOP)
  • PGY2 residency in oncology or health-system administration
  • Lean Six Sigma or other process improvement certification
  • Experience supporting early-phase oncology research and FDA, EMA, or sponsor regulatory audits
  • Lean Six Sigma Green Belt or Black Belt certification
  • Experience building or leading pharmacist residency or academic pipeline programs
  • Experience with regulatory horizon scanning and proactive compliance adaptation across multiple jurisdictions
  • Experience with cross-regional pharmacy governance in a distributed CRO, health system, or pharmaceutical manufacturing network
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The Company
294 Employees
Year Founded: 2007

What We Do

Deeply rooted in community oncology centers globally, the START Center for Cancer Research ('START') provides patients with access to specialized Phase 1 clinical trials for novel anti-cancer agents. With research sites in the United States and in Spain, Portugal, and Ireland, START’s clinical trial sites have conducted more than 1,500 early phase clinical trials, including for 50 therapies that have gained FDA/EMA approval.

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