Assoc. Director, Clinical Outsourcing- San Diego based preferred

Clinical Group            ·                Hybrid            ·           Full-time

Remote type: Hybrid
Locations: US CA San Diego
Time type: Full time
Posted on: July 14, 2023
Job Requisition ID: R3881

Who We Are:

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose – to relieve suffering for people with great needs, but few options.

What We Do:

Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine and psychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson’s disease, endometriosis* and uterine fibroids*, as well as clinical programs in multiple therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. *in collaboration with AbbVie

About the Role:

Responsible for providing day-to-day leadership, planning, organizing and executing of the sourcing process for clinical trials, while maintaining a focus on supplier quality and continuous process improvement. Serves a subject matter expert and owner of the vendor service portfolio(s) which includes, delivering the business objectives (Key performance indicators), the successful transitions, service delivery and cost effectiveness. In addition, responsible for issue resolution, managing vendor relationship (portfolio based), stakeholder management and effective communication. Provide operational expertise and strategic leadership, support, guidance and training to teams on all aspects of outsourced work.

Your Contributions (include, but are not limited to):

• Serve as a key partner to the clinical study teams, organizing the selection of service providers, coordinating requests for proposal and bid defenses, and negotiating work orders and change orders
• Ensure documentation and records related to these responsibilities are maintained in a GxP-compliant manner, and partner with QA to maintain a state of ‘inspection-readiness’ in the area of vendor identification, selection, qualification and routine oversight
• Ensure compliance with regulatory standards, ethical practices, outsourcing and procurement policies and procedures
• Lead the coordination of internal stakeholders to prioritize, identify, classify, qualify, and oversee third-party vendors that meet the company’s business requirements related to quality, expertise, cost, cybersecurity, deliverables, and timelines
• Provide guidance for outsourcing services and change management by leading the process following an RFP for contract negotiation, change order review and final reconciliation of contracts
• Manage the Approved Supplier List (ASL) of clinical service providers
• Develop and implement a vendor performance program that includes a sponsor oversight plan outlining analytics/metrics that measure value, including development of Key Performance Indicators (KPIs) to measure performance and drive business goals and improvements
• Drive Requests for Information and Requests for Proposals process for all phases of clinical trials and perform comparative bid analyses to ensure cost-effective value
• Establish, track, and maintain appropriate vendor issue management processes, including issue escalation and establish resolution plans for executing mitigation strategies
• Manage the evolution of vendor partnerships through their life cycles, including off-boarding and optimizing the vendor portfolio for enhanced purchasing power and reduced oversight needs
• Responsible for seeking updates from vendors on program metrics, deliverables, accomplishments, and delays
• Translate the usage of industry best practices, utilizing external sources such as benchmarking, data, and processes to continually drive improvements linked to an overall strategy for vendor selection and management
• May provide guidance on clinical trial site and investigator budgets to ensure clinical trial agreements and investigator budgets are executed timely while ensuring performance and value

Requirements:

• BS/BA degree and 10+ years of relevant business experience. and a minimum of 3 years in support of groups such as Clinical Development and/or R&D Operations OR
• Masters degree and 8+ years of similar experience as noted above
• Previous work in a clinical outsourcing role managing multiple studies in a full outsourcing model preferred
• Emerging as an internal thought leader with technical and/or business expertise
• Applies in-depth knowledge of own area of expertise to solve problems
• Applies expertise to manage critical projects and/or relationships
• Integrates analysis of business objectives and strategic direction to resolve problems and recommend solutions
• Has input into short-term strategy and may be involved in long-term strategy on a functional level
• Detail oriented, attention to accuracy and ability to consistently complete tasks on time
• Strong communications, problem-solving, analytical thinking, influencing skills
• Strong knowledge of FDA and other global clinical trial regulations and detailed knowledge of ICH and GCP guidelines
• Excellent leadership skills including ability to prioritize critical needs, act decisively, and handle a high volume of complex tasks within a given timeframe
• Experience interacting with a wide range of suppliers (e.g. Contract Research Organizations, Cooperative groups, Clinical laboratories, Core laboratories including ECG and Imaging service providers) to initiate, negotiate and execute legal and/or financial agreements in the clinical trials environment (biotech or pharmaceutical industry)
• Proficient with various desktop applications such as Microsoft Excel, Word, PowerPoint and/or Access
• Must be a team player – Willing to help and go the extra mile to get the job done but also know when to ask for support as well
• Experience in the creation policies and procedures, standard operating processes, job aids, training documents needed for the portfolio of outsourcing of clinical trials
• Experience in communication to both teams and executives, and time-management skills
• Ability to work with key stakeholders to anticipate new business needs
• Ability to work independently with little supervision and seek guidance as needed to clarify assignments or request for information

#LI-TM1

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.

The annual base salary we reasonably expect to pay is $161,800.00-$234,250.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

Please click here to apply.