Protara Therapeutics

Director

• 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%.

Executive Director – Market Access, Trade, GPOs, Patient Services

• 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.

Executive Director – Market Access, Trade, GPOs, Patient Services

Director, Data Management