June 13th, 2024 Clinical Operations

Senior Director, Clinical Vendor Management and Operations

San Diego, California, United States

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Please note that this position is based in San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.

The Senior Director, Clinical Vendor Management, DEI & FSP Operations plays a strategic and operational leadership role in delivering clinical trial services to the Clinical Operations organization. As a member of the Clinical Operations Leadership Team, the Senior Director develops and leads Contract Research Organizations (CRO), Flexible Service Providers (FSP), vendor and DEI strategies for the department and is accountable for Business Operations, Systems & Metrics, as well as oversight of the FSP. This role will lead a specialized team of individuals and be accountable for > $100M in contract value in support of all clinical trials in the Development portfolio.

Primary Responsibilities

Vendor Management

  • Sets the strategic direction for CRO, central lab, and preferred clinical trial vendor providers used in support of all clinical trials supported by Clinical Operations
  • Leads the develop robust vendor performance and governance programs, including the establishment of key performance indicators, key risk indicators, and effective vendor oversight to provide global, high-quality clinical trial services; ensures CRO/vendors alignment with relevant Acadia company goals and drives operational efficiencies
  • Develops preferred CRO and vendor partnerships and maintains relationships with external providers
  • Leads governance forum (Executive Steering Committees, Joint Operating Committees etc.) across clinical trial vendor relationships (CRO, central lab and other key clinical trial vendors)
  • Accountable for CRO, central lab, and key clinical trial vendor provider performance; ensures clear focus and understanding of all issues surrounding performance
  • Responsible for ensuring support received from CRO, central lab, and key clinical trial vendor provider is industry-leading in cost, speed, and quality, and provides value for the company through increased savings and efficiencies.
  • Provide expert insight and knowledge regarding rates, unit costs, and costing structures to enable optimal negotiations with study vendors, with emphasis on vendor performance, financial risk management, and compliance requirements
  • Leads ongoing review of external CRO and key clinical trial vendor environment and performance metrics benchmarking
  • Oversee vendor contracting, in partnership with Clinical Operations study teams, Procurement, Legal and Finance, overseeing Master Service Agreements, Work Orders and Change Orders
  • Serve as an escalation point for CRO and key vendor relationships; address and/or escalate vendor performance issues; identifies probable vendor risks and potential mitigation strategies

FSP Operations

  • Leads financial and resourcing demand forecast planning and management for Clinical Operations
  • Partners with study teams to ensure appropriate tracking of all study budgets, accruals, projections, invoices, etc.
  • Reviews operational budgets quarterly to ensure adherence to projections; monitors and optimizes operational costs and trial resourcing while maintaining high-quality standards
  • Serves as strategic thought partner and drives efforts and strategic initiatives; works closely with the leadership team to lead, develop, and implement critical cross-functional initiatives and organizational change workstreams

Diversity, Equity, and Inclusion

  • Provide overarching strategic direction for the implementation of Diversity, Equity, and Inclusion (DEI) initiatives within the Clinical Operations group
  • Foster a culture of collaboration, inclusion, and diversity advocacy, working closely with cross-functional teams and stakeholders
  • Oversee the development and implementation of DEI policies and procedures within Clinical Operations, ensuring alignment with organizational goals
  • Establish and monitor key metrics to assess the effectiveness of DEI initiatives, providing regular reports to leadership and identifying areas for improvement
  • Cultivate external partnerships and collaborations that align with DEI goals, promoting the organization's commitment to diversity in the clinical research landscape
  • Engage in ongoing evaluation and refinement of DEI strategies, staying informed about industry best practices and evolving standards to continuously enhance the organization's commitment to diversity, equity, and inclusion

Education/Experience/Skills

MSc, MBA, PhD or equivalent or related field.  Targeting 12 years within the pharmaceutical industry with Clinical Operations experience, including global experience and 8 years of leadership experience building strong technical & operations-based teams with business acumen, consultative skills, results orientation and influencing capabilities.  An equivalent combination of relevant education and experience may be considered.

Key Skills:

  • Extensive financial experience, including direct oversight of clinical trial and department level budgets, tracking and reporting
  • Clinical trial costing and resource benchmarking and forecasting experience
  • Extensive knowledge of a broad array of systems including Clinical Trials Management System (CTMS); Risk Based Monitoring (RBM); Electronic Trial Master File (eTMF); Electronic Data Capture (EDC); Clinical Studies Operational Data Warehouse & Analytics; Site Training and Resource Management etc.
  • Demonstrated ability to deliver results and achieve objectives within budget and timeline constraints. Proven experience in cost optimization and reduction
  • Significant experience in pharmaceutical/biotechnology and extensive knowledge of drug development processes, ICH-GCP guidelines, 21 CRF Part 11, and major Health Authority regulations as they pertain to the operational aspects of clinical trials
  • Comfortable working with Senior Executive Teams
  • Well networked with industry peers
  • Strong project management skills and effective matrix leader. Able to hold teams accountable to deliverables
  • Ability to travel up to 20%

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds.  Ability to travel independently overnight and work after hours if required by travel schedule or business needs.

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In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location. 

Salary Range
$223,000$278,700 USD

 

What we offer you (US-Based Employees):

  • Competitive base, bonus, new hire and ongoing equity packages
  • Medical, dental, and vision insurance
  • 401(k) Plan with a fully vested company match 1:1 up to 5%
  • Employee Stock Purchase Plan with a 2-year purchase price lock-in
  • 15+ vacation days
  • 14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st
  • 10 days of paid sick time
  • Paid parental leave
  • Tuition assistance

EEO Statement (US-Based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply – especially if the reason you are the best candidate isn’t exactly as we describe it here.

It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.

As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at talentacquisition@acadia-pharm.com or 858-261-2923.

Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.

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Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (“Acadia”). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in absence of an executed search agreement will not obligate Acadia in any way with the respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.