Sr. Director, Clinical Operations

ACADIA Pharmaceuticals   •  

Princeton, NJ

Industry: Biotech/Pharma

  •  

11 - 15 years

Posted 355 days ago

This job is no longer available.

The Senior Director, Clinical Operations will be a highly qualified and motivated individual who will have a leadership role in the clinical development of NUPLAZID (pimavanserin). This person will have extensive leadership and management experience, including demonstrable expertise in the successful planning and execution of clinical development plans and studies within neurology or psychiatry therapeutic areas. This is a high-profile management position, reporting to the Vice President of Clinical Operations. This position will be based in either the NJ or CA office. This is an office-based position.

Primary Responsibilities:

  • Leads the strategy and tactics to successfully work with vendors, investigators internal scientists, other departments within ACADIA, and the program clinicians to develop, execute and deliver clinical studies/programs supporting drug development with focus on quality, speed and cost.
  • Nurtures, promotes, and speeds the development of high-quality, high-performing study sites to support clinical trials.
  • Has broad experience selecting, managing, troubleshooting and negotiating with (CRO) vendors
  • Evaluates, refines, and makes recommendations for various operational constructs for study execution.
  • Cultivates a sustained and synergistic partnership with clinical investigators and institutions focused on science and clinical excellence
  • Leads strategies for patient recruitment and retention in clinical trials
  • Leads and shares best practices with internal and external stakeholders, as appropriate
  • Collaborates, where appropriate, with other areas of the business in the identification of study sites with potential value for the conduct of late phase trials
  • Establishes performance, quality, customer service, and business efficiency and innovation metrics for clinical sites; addresses systematic deficiencies and seeks to improve quality across study programs.
  • Maintains awareness of industry trends and developments to help define the future strategic direction for the clinical programs
  • Develops, oversees and implements study plans to ensure quality processes are followed
  • Supports mentoring and training of junior and cross-functional staff
  • Participates in and/or leads process improvements within/between lines to increase efficiencies and manage costs
  • Develops and measures appropriate metrics to assess and improve vendor and site performance.
  • Ensures that cross-functional process efficiencies are identified and maximized in accordance with project goals 
  • Works to the highest standards of Good Clinical Practice
  • Oversees and is accountable for program budgets, staffing and timelines.
  • Participates in the selection, management and oversight of CRO vendor partners, driving quality performance to milestones and deliverables

Education/Experience/Skills:

  • Bachelor’s degree in the life sciences or related field. Advanced degreepreferred.  Minimum 12years’ clinical development and management experience, with significant late-stage clinical trials experience in neuroscience with a focus on schizophrenia, dementia or depression preferred, and 8years’ proven experience in a leadership and people management role.
  • Experience leading and managing complex global clinical development programs is required
  • Superior verbal, written, and presentation communication skills in relating to colleagues and associates both inside and outside the organization.
  • Demonstrated track record of translating senior level research/scientific business requirements into operational strategies globally. 
  • Thorough understanding of local and international regulations applicable to clinical development; demonstrative knowledge of regulatory requirements globally and prior success in providing timely and quality support of regulatory submissions. 
  • Practical experience in clinical trial strategies, methods and processes; deep knowledge of clinical trial design. 
  • Demonstrated technical, administrative, and project management capabilities.  
  • Adept at creating and communicating a clear vision among direct reports, effectively aligning resources and motivating teams to achieve goals.
  • Demonstrated analytical abilities and proficient planning and negotiation skills.
  • Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills.
  • Demonstrated success with cross-functional collaboration and managing multiple assignments with timely and accurate output.
  • Travel 25%