Senior Clinical Outsourcing Consultant, Clinical Operations (Contract)

Who We Are:

ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode’s proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs, tissues and cells implicated in disease, enabling improved efficacy and potency. ReCode’s lead programs include RCT1100 for the treatment of primary ciliary dyskinesia caused by pathogenic mutations in the DNAI1 gene, and RCT2100 for the treatment of the 10-13% of cystic fibrosis patients who have Class I mutations in the CFTR gene and do not respond to currently approved CFTR modulators. RCT1100 and RCT2100 are inhaled disease-modifying mRNA-based therapies formulated using the SORT LNP delivery platform. ReCode is expanding its pipeline to develop potential therapies for other rare and common genetic diseases, including musculoskeletal, central nervous system, liver and infectious disease indications.

Summary of Position: 

ReCode Therapeutics is seeking a highly skilled and experienced Senior Clinical Outsourcing Consultant to join our dynamic team. In this role, you will report to the Head of Clinical Operations and will play a crucial role in managing and optimizing our clinical outsourcing activities in support of our clinical development programs. You will be responsible for collaborating with our cross-functional teams to deliver on ReCode’s mission of powering the next wave of genetic medicines. 

Responsibilities: 

• Partner with Clinical Project Teams/FP&A to create enrollment assumptions, clinical study budgets and clinical study forecasts to ensure financial estimate/spend harmonize with project timelines
• Track clinical trial accruals and forecasts related to CRO and service provider spend. Highlight to senior management potential financial risks and fluctuations
• Manage or support monthly clinical trial reporting activities including study enrollment, work completed to date, current and estimated budget spend, study budget projections for new studies, etc.
• Partner with Legal Contracts Team on all vendor, KOL, and clinical trial agreements
• Manage and review CTA budgets in partnership with Legal team
• Manage all stages of contract lifecycle including risk management analysis, due diligence, requirements and information gathering, RFP preparations, selection, negotiation, and termination.  
• Recommend and implements outsourcing parameters regarding production and quality in support of business objectives,
• Analyze and manage partner’s performance to ensure financial and operational objectives
• Review key performance scorecards and seek feedback from key internal stakeholders. Address areas of concern effectively and provide recommendations to mitigate against poor performance.
• Collaborate with management to prioritize prospecting efforts and lead follow-up.  
• Facilitate the creation and management of a preferred partner environment, enabling streamlined selection and strategic pricing negotiations with partners;
• Lead and manage the development of standards for vendor interaction and processes
• Liaise cross-functionally to troubleshoot and provide resolution to vendor issues;
• Possess solid understanding of outsourcing processes from RFI/RFPs to vendor selection/management  
• Demonstrate thorough knowledge of contracting and ability to negotiate business terms and conditions
• Lead Clinical Outsourcing activities for Clinical Operations Department and other functional areas as necessary
• Support clinical trial vendor financial-related matter/issues including invoice issues
• Provide input to continuously improve financial and business operations processes 

Qualifications: 

• BS/BA required in life sciences, business, or related field 
• 8+ years of Clinical Outsourcing experience in the biotech/pharma industries with knowledge of strategic sourcing  
• Clinical Outsourcing experience across all phases of development from Phase 1-3 with emphasis on early phase development   
• Track record of success with vendor management and CROs and representing the sponsor to internal and external stakeholders (ie site/vendor relationships) 
• Strong organizational skills and able to prioritize and manage multiple ongoing projects simultaneously 
• Strong knowledge of clinical trial vendor budgets and scopes  
• Excellent oral and written communication skills
• Champion for change within a fast-growing company/department  
• Strong knowledge of clinical vendor management best practices, regulations, and industry trends
• Demo