Arvinas

Operations

• Provides operational support to Medical Affairs department and projects, including managing project timelines and budget
• Supports scientific publications operations, including publication tracking and reporting, author and agency coordination, document and journal submission management, compliance reviews, and maintenance of the Medical Affairs publications site
• Assists in the planning and execution of congress activities
• Assists in the planning and execution of Advisory Boards to include FMV assessments, tracking consultant agreements, and ensuring proper documentation
• Coordinates Medical Review Committee process for review of scientific exchange materials
• Manages the contracting process with external consultants/vendors and tracks progress
• Coordinates functional team meetings and generates and distributes meeting minutes
• Collaborates with internal cross functional stakeholders to ensure timely, quality execution of activities and projects
• Supports cross-functional communication across the CDMA functional teams through appropriate methods
• Supports high-priority, cross-functional initiatives that advance AI adoption, digital enablement, and other strategic CDMA priorities
• Supports the development and execution of the AI, automation, and digital enablement strategy for CDMA, driving solutions that enhance productivity, operational efficiency, and decision making across functions

Associate Director, Clinical Development – Medical Affairs Operations, Innovation

• Serves as the Arvinas subject matter expert (SME) and main point of contact (POC) for external data management activities across studies and data interchanges with the clinical database.
• Serves as the Arvinas SME and main POC for vendor oversight of the central labs and oversight of biosample sample movements between the central lab and analyzing lab.
• Oversees external data transfer agreements, specifications and data interchanges to the clinical database from 3rd party vendors/analyzing labs. Ensures data transfer specifications are aligned with protocol and analysis requirements.
• Develops and implements standardized data flows and integration of structured data in the clinical database using standardized, SDTM compliant DTSs for wide variety of data types.
• Provides ad hoc support for other technical data management activities such as: Arvinas EDC Acceptance Testing, review of EDC data structures for compliance with Standards and SDTM, review of external data file formats, verification of business analytics outputs, etc.
• Provides Arvinas DM oversight of activities performed by DM CRO/DM Vendors.
• Reviews and approves DM-related documentation, including contributing to Arvinas Data Interchange Plan and Arvinas Data Review and Data Quality Oversight Plan.
• Supports clinical study team data review using the JReview application, including user access administration and training; creates and maintains report objects in JReview; creates and maintains Data Listing Repository; provides technical support for data reviewers.
• Provides operational support for Clinical Study Teams and Biomarker Subteam.
• Supports process definition, Arvinas SOP and quality document development.
• Supports vendor contract and work order review.
• Provides oversight of central lab vendors and central lab vendor databases (LIMS), study documentation review (e.g., Lab Manual) and approval, lab kit review. Ensures alignment of central lab LIMS and the protocol and operational requirements for the study.
• POC for central lab Quality Events and Quality Incidents.
• Provides oversight of Analyzing Lab vendors (Data Transfer Specifications development, raw data transfers, biosample movements to/from laboratories).
• Performs PK biosample tracking for dose escalation clinical studies from Central Lab to PK Lab, in conjunction with Bioanalytical Scientist and Clinical Pharmacology; ensures the availability of biosample results for Cohort Review Committees and decision making.
• Provides oversight of biosample management and movement, especially between central lab and analyzing labs. Supports biosample movements from laboratories to Biorepository Vendor for long-term storage/biosample archive.
• Assesses sample loss risk and mitigates sample-related issues with CROs and lab vendors.
• Creates and approves biosample disposition-related documentation and ensures proper eTMF indexing of sample management/disposition related documentation.
• Encourages innovation, process improvement, and technology enhancements to increase Drug Development efficiency.
• Develops and maintains SOPs, Work Instructions, and other quality documents related to data management and biosample management.

External Data Management – Biosample Operations Lead

Medical Director

• Partner with discovery and biology leadership and provide clinical input and guidance to develop the neuroscience corporate strategy.
• Responsible for trial design of Phase I/II/III research trials targeting neurologic diseases, requiring expertise and stewardship in the areas of CNS/Neurology.
• Directly supervise and monitor trial conduct.
• Work closely with all functions of the organization and external partners to manage trial execution and investigators’ engagement.
• Collaborate in developing global regulatory plans and play a key role in regulatory meetings in partnership with regulatory affairs. Identify opportunities for external collaboration.
• Follow important developments and relevant trends in the scientific literature and develop/maintain contacts with external experts to support understanding of the candidate drug effects and to gain strategic insights to the further development of study and overall program.
• Develop effective relationships with external providers.
• Provide clinical assessments of potential in-licensing assets, identifying novel therapeutics opportunities as well as critical study design and execution challenges.
• Review written materials and provide editorial comments for clinical study reports and manuscripts.
• Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws.

Senior Medical Director – Clinical Development, Neuroscience

Director

• Design and implement a comprehensive API supply chain strategy for specific projects at Arvinas.
• Working with Process R&D, craft and distribute request-for-proposals to CDMOs to access intermediates and API supplies to enable the Arvinas pipeline.
• Evaluate proposals and quotes matching the capabilities of the supplier with the project requirements in terms of quantity, quality, and timing of deliverables.
• Working with Process R&D select the best providers of service to meet project needs.
• Working with internal and external legal resources craft master service agreements and contracts to reflect required deliverables.
• As the primary contact with the contractors, manage day-today interactions to ensure that deliverables are completed as contracted.
• Contribute to technical oversight of contracted suppliers in execution of API-related deliverables.
• Drive forecast planning and inventory management of project intermediates and APIs to meet near-term and long-term goals. Incorporate risk-mitigation strategies.
• Participate in budget-planning for API campaigns and track all spend relative to budget.
• Communicate production schedules to Project Management and the project team as part of project Integrated Development Plans for specific Arvinas assets.
• Manage the CMC API Supply Chain interfaces with Drug Product Supply, Quality Assurance, and Regulatory Compliance.
• Establish detailed plans to guide project chemical development activities from early development to commercialization, ensuring all quality and regulatory requirements are proactively satisfied.
• Participate in strategy discussions to ensure that decisions align with agreed upon business direction and processes.
• Lead the collection of relevant data and reports from suppliers and contribute to drafting of INDs, NDAs, and associated amendments.

Associate Director, Clinical Development – Medical Affairs Operations, Innovation

External Data Management – Biosample Operations Lead

Senior Medical Director – Clinical Development, Neuroscience

Senior Director, External API Manufacturing, Supply