
Protara Therapeutics
Remote Jobs
Tenacious in our search for transformative therapies
2 Jobs
Executive Director – Market Access, Trade, GPOs, Patient Services
Protara TherapeuticsTenacious in our search for transformative therapies
• Develop, implement and continual evaluation of the Trade Distribution model to meet the needs of Protara customers and patients. • Own relationships with channel partners; leverage available data to identify trends and opportunities to improve distribution efficiencies, address risks and manage budget. • Oversee returns, adjusting transactions, new customer set-ups, credit limit requests, Trade notifications, and order reviews. • In partnership with IT, ensure quality of ex-factory sales data. • Oversee management of relationships and contracts with US Specialty Distributors. • Partner with Supply Chain to manage product dating and maintain appropriate inventory at 3PLs. • Liaise with Protara Legal team to ensure compliance to applicable laws and regulations. • Serve as a subject matter expert as a member of New Product Launch teams. • Partner with BD and Marketing to evaluate and recommend distribution strategies for new products. • Oversee Trade policies and procedures, such as orders, returns, replacements, credit/rebill requests, inventory, and chargeback processing. • Business travel by air, train, or car is required up to 50%.
• Development and execution of data quality strategies, risk-based data review plans, and cross-study harmonization. • Direct the design, testing, validation, and maintenance of clinical databases and electronic data capture (EDC) systems. • Ensure consistent application of CDM standards, tools (e.g., CDISC, Medidata Rave), and procedures. • Oversee issues resolution and data integrity across outsourced vendors and internal teams. • Provide proactive input into clinical protocol design to ensure data collection strategies align with scientific and regulatory requirements. • Review and contribute to clinical protocols and statistical analysis plans to ensure alignment with data collection objectives; cross-project consistency and standardization of case report forms. • Partner with internal stakeholders to align timelines and data delivery requirements. • Participate in cross-functional study teams; influence protocol design, study setup, and data strategy from study start to submission. • Actively support submission readiness, including data integration and final deliverables for regulatory filings. • Participate in protocol development, clinical study reports (CSR), and submission activities. • Manage relationships with CROs and third-party vendors, ensuring alignment with contractual deliverables and performance expectations. • Establish standards and oversight processes for EDC setup, CRF development, data validation, discrepancy management, and database lock. • Drive consistency and scalability through implementation of standards (e.g., CDISC/CDASH/SDTM) and SOPs. • Development and improvement of clinical data management processes and tools. • Participates in the evaluation of organizational needs, defining resource strategies, and managing departmental budgets and headcount planning.