Associate Clinical Trials Director

Neurocrine Biosciences • San Diego, CA

2d • $173,600 - $237,000

About The Position

Responsible for the overall management of the Clinical Operations team and may contribute to the development of strategic plans and objectives of the Clinical Operations team by executing Neurocrine's clinical studies (all phases). Ensures clinical study activities are conducted in compliance with FDA regulations, European Union (EU) Directive, International Conference of Harmonization (ICH) guidelines, and are in adherence with corporate and departmental Standard Operations Procedures (SOPs) and Good Clinical Practice (GCP). A key focus will be on the oversight of CROs, external vendors and internal stakeholders to ensure studies are conducted according to timelines, budgets, and resources to achieve program objectives and corporate goals. The Associate Director will also support the career development of multiple direct reports within the clinical operations group.

Requirements

• BS/BA degree AND 12+ years of clinical trial management experience, including CRO/vendor management (domestic and international), monitoring of budget scope, clinical site monitoring or related experience required. OR Master’s AND 10+ years of similar experience noted above
• Anticipates business and industry issues; recommends relevant process / technical / service improvements
• Demonstrates broad expertise or unique knowledge
• Considered an expert within the company and may have external presence in area of expertise
• Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team
• Ability to work as part of and lead multiple teams
• Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams
• Excellent computer skills
• Excellent communications, problem-solving, analytical thinking skills
• Sees broader picture and longer-term impact on division/company
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Excellent project management, strong project leadership skills
• Proven ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback; experience productively partnering cross functionally and with customers to advance work effectively and efficiently
• Proven ability at analyzing data and information to derive conclusions and drive sound decision making
• Works to improve tools and processes within functional area
• Detailed knowledge of clinical drug development process including working knowledge of ICH, GCPs, FDA regulations and EU directive
• Ability to effectively manage, mentor and train personnel and ability to motivate and influence personnel to achieve goals
• Expertise directing global studies, particularly in endocrine related indications and/or rare diseases
• Strategic vendor management skills, particularly CROs or similar complexity
• Must possess strong presentation and communication skills for internal and external presentations
• Strong computer skills, organizational skills, interpersonal and team participation skills are essential

Responsibilities

• Contribute to the design and implementation of clinical strategies for area of responsibility and participate in formulating strategic plans and objectives for broader organization using internal and external resources
• Provides leadership to the Clinical Operations study team (Clinical Trial Managers, Specialists, Clinical Trial Associates, and other subordinate employees)
• Supports the tactical implementation and execution of the clinical development process (all phases) primarily for selected programs
• Accountable for smaller subfunctions
• Ensures program activities are conducted in compliance with FDA regulations, EU Directive and ICH guidelines, and are in adherence with corporate and departmental Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP)
• In collaboration with the Outsourcing function, works with the Clinical Trial Manager or Sr. Clinical Trial Manager to manage vendor scopes individual study budgets, and change orders
• Maintains clinical trial timelines to achieve corporate goals
• Supports the creation and establishment of critical metrics to benchmark activities needed to develop and revise performance and reach and maintain the highest possible standards of excellence
• Identifies and introduces process improvements within the clinical organization
• In collaboration with Outsourcing, manages relationships and expectations with CROs, external vendors, and other clinical contract service providers. Act as point of contact with external bodies
• Manages inter-department relationships (e.g., Regulatory, QA, DM, Stats, etc) to ensure adequate support for clinical programs as well as provide input into cross-functional meetings and documentation
• Interfaces with Clinical Development by providing operational input to clinical protocols, clinical development plans, and clinical study reports
• Support the recruitment, training, management, and career development of subordinates within the clinical operations group
• Manages operational activities of clinical programs with corporate partners
• Performs additional tasks and duties as assigned

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior