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Associate Director, Clinical Outsourcing

CRISPR Therapeutics AG

This is a Full-time position in Cambridge, MA posted November 21, 2021.

Company Overview

CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform.

CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA.

CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, and rare diseases.

To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc.

CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S.

subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom.

Job Summary

The position reports to the Sr. Director, Clinical Outsourcing.

The Associate Director, Clinical Outsourcing will be responsible for managing outsourcing of clinical research related tasks to external services providers on a global basis and acting a vendor management lead.

The successful candidate must be hands-on and comfortable developing procedures, templates and building relationships.

Responsibilities

• Lead the clinical outsourcing process for assigned studies and work with Clinical Operations Teams to deliver robust contracting agreements:

– upfront assessment of risk

– development of detailed specifications

– selection of suitable suppliers

– leading the analysis and comparison of proposals
– for both service (activity) and cost provision

– negotiating costs and content

– negotiating and executing contracts

– negotiating and executing contract amendments

• Ensuring that contracts maximize value whilst minimizing risk across a broad scope of clinical / therapeutic outsourcing services (including Full Service Outsourcing) as well as regional, regulatory and legal requirements.

• Manages the identification and selection process of clinical vendors such as CROs, central labs, etc.

Vendor Selection and Qualification 

• Lead and manage the Request for Information (RFI) and Request for Proposal (RFP) process for outsourced providers, ensuring a thorough evaluation and selection process.

• Act as the quality liaison for vendor qualification; ensure that sponsor obligations for vendor selection and qualification are followed, including vendor audits, as applicable.

• Proactively manage and lead outsourcing contracting activities for assigned clinical study programs, ensuring adherence to the outsourcing strategy, company policy and procedures, as well as legal, government and regulatory requirements where relevant.

• Build cross-functional partnerships with clinical development leadership, procurement, project management, legal, finance, quality assurance and other departments as appropriate to ensure that outsourcing and contracting needs are met and handled in an optimal and efficient manner.

Vendor Oversight

• Oversee and lead supplier governance activities; coordinate Joint Steering Committee (JCS) meetings and monitor key performance indicators (KPIs) and performance metrics; facilitate early escalation of cross-functional vendor issues; collaborate with study teams to create and manage risk mitigation plans or corrective action plans for vendor performance or quality issues.

• Assist in the creation and management of overall outsourcing strategy, including potential preferred provider relationships, functional service provider, negotiated rate cards, volume discounts, etc.

• Establish and support vendor relationships.

Contribute to the development of an established preferred clinical vendor list.

May serve on preferred provider committees and/or governances as needed.

• Meet with clinical trial managers, functional managers, and QA as needed to ensure vendors are meeting expectations and review progress against contract.

• Ensures that expectations within and between organizations with regard to establishing costs, budgeting and reporting, invoicing, turnaround times, contractual documentation and approach, payment schedules and other business practices are established and managed.

• Maintain outsourcing SOPs, RFP templates, Change Order and Change Notification Form trackers, Confidentiality Agreements (CDAs), Master Service Agreements (MSAs) and project-specific agreements.

Finance

• Assist in the management of clinical trial budgets and development of strategic collaborations

• Develop cost estimates for study scenarios, forecast full study budgets and keep them up-to-date, working closely with each study manager

• Work closely with finance to assure the assumptions for studies are aligned between finance and clinical forecasting

• Review invoices of significance against vendor contracts to ensure accuracy against contracts, and raise any concerns in a timely manner to finance and Sr. Director, Clinical Outsourcing

Qualifications

• Bachelor’s Degree in scientific or business discipline.

• Experience working with clinical vendor contracts (e.g.

CRO, Central Laboratory, etc)

• Minimum 10 years’ experience in a clinical outsourcing function in the pharmaceutical, biotech or medical device industry.

• Ability to successfully interface with vendors, collaborators, all internal departments and at all levels of leadership within the organization

• Working knowledge of Clinical/Drug Development/Clinical Operations vendor contract best practices; familiarity with Regulatory Guidelines including ICH GCP. 

• Previous experience working with clinical operations and finance is strongly preferred.

• Excellent interpersonal, organizational and multi-tasking skills.

CRISPR Therapeutics, Inc.

is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.