BBOT

Director

• Lead the drug product development strategy for assigned small molecule programs, including solid oral dosage forms and other relevant formats.
• Design, review, and oversee formulation development, process development, and technology transfer activities.
• Develop phase-appropriate Clinical formulations with a view to overall program success on aggressive development timelines.
• Author, review, and approve key CMC documentation including development reports, batch records, and regulatory filings (INDs, IMPDs, NDAs, etc.).
• Manage outsourced development and manufacturing activities at CDMOs, ensuring technical rigor, compliance, and timeline adherence.
• Collaborate with internal CMC stakeholders including Process Chemistry, Analytical Chemistry, Reg CMC, and Supply Chain.
• Collaborate effectively as needed with ex-CMC partners, including Clin Ops, Clin Pharm, Global Reg, Quality, DMPK and Tox.
• Provide technical leadership on drug product troubleshooting, risk assessments, and change controls.
• Ensure activities are compliant with GMP, ICH guidelines, and global regulatory requirements.
• Travel as needed (up to 20%) to support critical manufacturing campaigns and attend company gatherings.

Associate Director, Drug Product, CMC

General Counsel

• Draft, review, and negotiate a wide range of clinical site agreements
• Draft, review, and negotiate a wide range of research agreements
• Partner with internal teams including clinical operations, research, and regulatory to provide timely and pragmatic legal advice
• Support the legal aspects of company operations, including vendor management and internal policies
• Manage up-to-date form agreements consistent with industry standards and applicable laws
• Identify legal risks and provide practical solutions that enable the business to move forward

Corporate Counsel – Research & Development

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Associate Director, IT – Development, Research, CMC Business Partner

• Lead the clinical pharmacology strategy for multiple oncology programs, ensuring alignment with regulatory requirements and scientific standards.
• Design and oversee clinical pharmacology studies to support multiple oncology program clinical development.
• Collaborate with cross-functional teams, including clinical operations, biostatistics, and regulatory affairs, to drive the advancement of drug development programs.
• Drive application of model-informed drug development (MIDD) approaches, including population PK/PD and exposure–response analyses.
• Author relevant sections/modules of regulatory documents (including INDs, IBs, CTAs, IMPDs, NDAs, briefing packages, or other regulatory dossier) and serve as subject matter expert in regulatory interactions with FDA and other global health authorities.
• Stay abreast of industry trends and advancements in clinical pharmacology and oncology, contributing to the scientific community through presentations and publications.

Senior Director, Clinical Pharmacology

Clinical Operations

• Reporting to the Director of Clinical Operations, this individual contributes to the development and implementation of strategic direction of clinical trials, acts as study team lead for Clinical Operations and is responsible for delivery of all clinical trial operational activities, across one or more studies.
• Accountable for overall management of clinical trials, including providing strategic direction to the study team, to meet corporate goals and timelines
• Collaborate with the Clin Development to assess study progress, ensure proper study conduct and adherence to the protocol
• Central role maintaining relationships with other internal functions, strategic partners and CROs
• Oversee functional deliverables to support program objectives, identify risks to study timelines, propose mitigations, and implement solutions with team and management support
• Communicate program status, cost, and issues to senior management
• Monitor global regulatory intelligence for international industry practices for operational efficiency and compliance
• Responsible for the coordination of team meetings, as assigned, with both internal and external partners
• Serve as a clinical trial lead for one or more trials and responsible for implementation, planning, and execution of clinical trial activities
• Cultivate and maintain strong relationships with investigators, and trial site managers and other site staff, as applicable
• Participates in the selection of vendors and manages their activities.
• Organize investigator meetings, as needed
• Coordinate timely data review to identify trends and discrepancies
• Responsible for all aspects of site management from feasibility, selection, start-up, maintenance, and close out
• Select, assess, and approve sites for activation
• Contribute to study budget, including regular forecasting and internal reporting
• Review invoices against scope of work and work completed to date, and to identify and communicate variances
• Responsible for management of CRO and vendors to support clinical operations contracted for the assigned study/studies

Associate Director, Clinical Operations

Supply Chain

• Support the development and execution of clinical supply strategies for planning, sourcing, and distribution to enable global clinical studies.
• Assist in sourcing commercial comparators, including due diligence support, documentation, vendor coordination, and ensuring compliance with country-specific sourcing regulations.
• Collaborate closely with the SVP, CMC, clinical development, and operations teams to align on supply needs, timelines, and resource requirements.
• Contribute to managing the end-to-end clinical supply chain process—from forecasting to delivery at clinical sites—ensuring compliance with protocols, international regulations, and trial timelines.
• Develop and maintain forecasting models for clinical trial materials based on protocols, enrollment projections, and country-specific factors.
• Lead IRT system setup, user acceptance testing (UAT), configuration, and ongoing maintenance for supply tracking and visibility.
• Monitor inventory levels, expiry dates, and batch traceability to maintain appropriate stock at sites and depots while minimizing waste.
• Identify potential supply risks and implement mitigation plans to avoid trial disruptions.
• Support resolution of supply chain issues impacting timelines and ensure continuity of supply.
• Assist in managing clinical supply budgets through cost-effective sourcing and distribution practices.
• Oversee drug accountability, returns, reconciliation, and destruction per GxP and SOP requirements.
• Ensure all clinical supply activities comply with cGMP, GDP, and relevant global/country-specific regulations.
• Support quality processes for packaging, labeling, and distribution to maintain product integrity and regulatory standards.
• Act as a primary point of contact for clinical supply matters with internal stakeholders.
• Manage day-to-day relationships with external vendors (e.g., manufacturers, packagers, logistics providers) to ensure compliant and on-time delivery.
• Contribute to process enhancements in clinical supply chain operations by implementing best practices and driving efficiency gains.

Associate Director, Clinical Supply Chain

• Develop and execute strategies for the planning, sourcing, and distribution of clinical trial supplies to support global clinical studies.
• Support sourcing commercial comparators, including due diligence, documentation, vendor coordination, and compliance.
• Collaborate with the SVP, CMC, and clinical development teams on supply needs and timelines.
• Oversee the clinical supply chain process from forecast to delivery.
• Develop accurate forecasting models for clinical trial material needs.
• Ensure clinical supply chain activities meet regulatory requirements.
• Serve as the primary contact for internal stakeholders on supply chain matters.
• Manage relationships with external vendors for the delivery of clinical trial materials.
• Implement process improvements in clinical supply chain management.

Director, Global Clinical Supply Chain – Oncology Clinical Trials

• Own and provide strategic oversight and support for enterprise G&A business systems, with primary responsibility for NetSuite ERP and Paylocity HRIS/Payroll.
• Partner with Finance, Accounting, FP&A, HR, Legal, Procurement, and Corporate Operations to ensure systems effectively support business processes and reporting needs.
• Serve as the subject matter expert for NetSuite, Paylocity and Gatekeeper Contract Lifecycle Management configuration, integrations, master data, roles and permissions, reporting, and system controls.
• Lead system implementations, upgrades, enhancements, and optimization initiatives for G&A platforms.
• Manage relationships with system vendors and implementation/support partners, ensuring service quality and compliance alignment.
• Own and drive SOX compliance for G&A systems, including IT General Controls (ITGCs) for NetSuite, Paylocity, and related applications.
• Design, document, and maintain controls related to user access, segregation of duties, change management, and system operations.
• Partner closely with Finance, Internal Audit, IT, and external auditors to support SOX audits, walkthroughs, testing, and remediation.
• Proactively identify control gaps or risks and lead remediation efforts to strengthen the company’s SOX control environment.
• Act as a key liaison between IT and G&A stakeholders to translate business requirements into compliant, scalable system solutions.
• Provide guidance and training to system users on proper system usage, control awareness, and audit-ready practices.
• Communicate system risks, compliance posture, and improvement opportunities to senior leadership.
• Drive ongoing optimization of NetSuite, Paylocity, Gatekeeper, and related G&A systems to improve efficiency, data quality, and user experience.
• Stay current on evolving SOX requirements, public company best practices, and emerging trends in ERP and HRIS platforms.

Associate Director, IT – G&A Business Partner

Paralegal

• Serve as the primary owner of the end-to-end contracts process, including intake, tracking, execution, amendments, renewals, and terminations
• Administer and maintain the company’s contract lifecycle management system and contract repositories
• Coordinate contract execution with internal stakeholders and external counterparties
• Track contractual obligations, renewal dates, and deadlines, proactively managing follow-ups and risk visibility
• Support audits, diligence requests, and internal reporting related to contracts
• Continuously improve contract templates, workflows, and processes to support a scaling organization
• Support corporate governance activities, including preparation and organization of board and committee materials, resolutions, consents, and minutes
• Assist with the preparation and coordination of public company securities filings (e.g., Forms 10-K, 10-Q, 8-K, proxy statements), including document management and backup materials
• Maintain corporate records, entity documentation, and compliance calendars
• Partner cross-functionally with Finance, Business Development, and Operations on legal support needs
• Interface directly with outside counsel and legal vendors
• Support special legal projects as needed, including financings, transactions, and strategic initiatives