Allucent

Director

• At** Allucent™**, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
• As the Sr. Director, CMC, you will:
• - **Lead end-to-end CMC strategy** across drug substance, drug product, and analytical development—from early-stage evaluation through regulatory submission and commercial launch with a focus on scientific aspects.
• - **Drive regulatory excellence** by authoring and reviewing CMC submissions, leading Health Authority communications, and ensuring compliance with FDA, EMA, and ICH guidelines.
• - **Prepare product development plans** from early development through Phase 4.
• - **Manage and lead direct reports** through development and performance management and by providing training on current and new regulatory requirements.
• - **Perform other scientist related duties**, as needed.

Senior Director, CMC

Software Engineer

• **Key Responsibilities:**
• - Design and implement end-to-end data pipelines using Azure Databricks, Azure Data Factory, and ADLS Gen2.
• - Build scalable and performant data models for data lakes (Medallion architecture), data warehouses, and operational systems.
• - Develop ELT/ETL frameworks for ingestion from APIs, relational sources, flat files, and third-party systems (e.g., Dynamics 365, Veeva, EDC).
• - Optimize data transformations, partitioning, and delta lake performance for analytics workloads.
• - Leverage Python and PySpark for data ingestion, cleansing, enrichment, and advanced transformations.
• - Implement CI/CD pipelines for data workflows using Azure DevOps and Git, including automated testing, deployment, and monitoring.
• - Develop and integrate RESTful APIs for cross-system data exchange and automation.

Data Developer

• Responsible for overall quality and management of the delivery clinical trial projects and programs
• Manages complex, cross-functional resource requirements in line with budgeted, time, scope, and quality expectations for project delivery
• Oversees budgets and ensuring correct financial forecasting, planning, invoicing and timely implementation of out of scope activities
• Reviews and approves content and costing of proposals
• Ensures effective risk management across the project delivery lifecycle
• Negotiates and influences internal and external team members in a professional manner and with successful outcomes
• Effectively solves problems with projects teams by applying strategic thinking and conflict resolution skills
• Balances multiple competing priorities, with effective and efficient resource utilization across projects and programs
• Serves as key contact for assigned clients on delivery of scope, customer satisfaction on services and capabilities and the assessment of client needs
• Shows knowledge of and insight into general business principles and practices, and is able to balance business priorities
• Demonstrates a growth mindset, and approaches complex challenges with creativity and flexibility
• Leads by example and encourages team members to develop strong solutions for clinical trial delivery
• Supports the recruitment and interviewing of new employees
• Responsible for supervision of project staff and communication with functional managers, including performance feedback
• 10% of Business travel is required for this position, including possible international travel

Project Director – Neurology, Immunology, Infectious Diseases

Clinical Operations

• Driving project success by leading cross-functional teams to deliver clinical trials on time, within scope, and on budget.
• Ensuring excellence and compliance by developing and executing project plans aligned with GCP, SOPs, and regulatory standards.
• Aligning stakeholders by serving as the primary point of contact for sponsors, vendors, and internal teams.
• Optimizing vendor performance through strategic selection, management, and oversight.
• Mitigating risks and control budgets by proactively addressing challenges, scope changes, and resource allocation.
• Maintaining inspection-ready documentation by leading key meetings and ensuring the Trial Master File and study records are complete.

Senior Clinical Project Manager

Medical Director

• Advise sponsors on product development strategy, protocol design, endpoint selection, and clinical trial feasibility for Phase I–IV programs
• Provide medical oversight and safety leadership for assigned clinical trials, including medical monitoring and safety review activities
• Support business development efforts through proposal review, budget input, and participation in sponsor and bid pursuit meetings
• Lead and support critical safety activities including SAE/SUSAR review, DSMBs, dose escalation meetings, and protocol deviation oversight
• Review and ensure scientific integrity and medical consistency across key trial documents including protocols, ICFs, CSRs, DSURs, and PSURs
• Mentor cross-functional teams and provide therapeutic expertise to internal stakeholders, investigators, and clients throughout study execution

Senior Medical Director/Executive Medical Director

• At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
• We are looking for a Project Director (PD) to join our A-team (office-based*/remote). As a PD at Allucent, you are responsible for coordinates and oversees operational project teams, customer satisfaction and continuous improvement of processes within the Global Clinical Operations (GCO) department. This position controls and monitors the quality and full-service delivery of clinical trial Allucent customers.
• About this role:
• As a proactive project director, you will:
• - **Oversee the project **and be responsible for the overall quality and management of the deliver clinical trial projects and programs. This includes overseeing the budget, reviewing and approving content and costing of proposals, problem solving with project teams, and balancing multiple competing priotities.
• - **Serve as the key contact for assigned clients** on delivery of scope, customer satisfaction on services and capabilities and the assessment of client needs.
• - **Lead the project team. **You will demonstrate knowledge of and insight into general business principles and practices, demonstrate a growth mindset, and support the recruitment and interviewing of new employees.

Project Director

• **About the role:**
• As an expert in clinical pharmacology, you will:
• - **Take independent leadership in providing strategic clinical pharmacology advice** to clients within a cross-functional team, covering overall drug development activities.
• - **Autonomously lead the design, analysis, and interpretation of clinical pharmacology studies** (including renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) and offer recommendations to enhance pharmacokinetic sampling and dosing strategies.
• - **Thoroughly assess the technical and scientific components** of PK and PK/PD projects and programs for clients, with knowledge of noncompartmental analysis as well as population PK, PBPK, and QSP modeling.
• - **Oversee the development** of statistical and PK analysis plans, standalone PK/PD reports, and PK/PD sections of clinical study reports, and take the lead in reviewing clinical protocols, clinical study reports, clinical pharmacology strategic plans, INDs, clinical pharmacology and safety sections of NDAs, Investigator Brochures, FDA briefing packages, and other clinical and regulatory documents.

Director, Clinical Pharmacology

• __About the role__
• This role combines scientific leadership and strategic impact, leading population PK analyses while developing innovative approaches to improve efficiency and accuracy. You will design, analyze, and interpret clinical pharmacology studies, provide strategic guidance to clients, and contribute to regulatory documents and agency interactions. In addition, you’ll foster client relationships, support business development, and stay at the forefront of PK/PD advancements to drive continuous improvement.
• **Your main responsibilities will include but not limited to: **
• - Lead and conduct population PK analyses using advanced modeling tools and methodologies
• - Develop and implement innovative approaches to enhance the efficiency and accuracy of PK analysis
• - Design, analyze, and interpret clinical pharmacology studies (renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) and provide guidance to optimize pharmacokinetic sampling and dosing strategies
• - Provide strategic guidance to clients, owning deliverables and developing clinical pharmacology plans
• - Author and review PK reports and clinical pharmacology sections of regulatory documents
• - Represent clients in regulatory interactions and contribute to business development and relationship management

Director, Pharmacometrician

Infrastructure Engineer

• Design, deploy, and manage infrastructure solutions to support business operations and growth.
• Collaborate with cross-functional teams to assess and implement infrastructure requirements.
• Maintain and optimize systems and services related to Azure, Azure DevOps, AWS, and M365.
• Monitor system performance, troubleshoot issues, and ensure high availability and reliability.
• Develop and enforce best practices for infrastructure security, compliance, and disaster recovery.
• Lead infrastructure projects, including upgrades, migrations, and new implementations.
• Provide mentorship and technical guidance to junior team members.
• Stay updated on emerging technologies and recommend improvements to existing systems.
• Mentor team members to promote standardization in project initiatives.
• Actively contribute to staff learning & development within the company.

Senior Infrastructure Engineer

Data Scientist

• *At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
• We are looking for Clinical Data Manager III (CDM III) to join our A-team. As CDM III at Allucent, you will manage and coordinate DM deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting.
• **In this role your key tasks will include:**
• - Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites)
• - Plan and project the resources required including management of tasks, timelines, risk and quality
• - Monitor tasks against and keep track on budget, forecasts, identify and trigger changes of scope requests
• - Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements
• - Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements
• - Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan), lead and coordinate the review of (electronic) case report forms (eCRFs)
• - Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks
• - Create training materials for EDC users and provide project-specific training as required
• - Review and validate clinical data to ensure consistency, accuracy, integrity and completeness
• - Create data cleaning strategy in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock)
• - Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data
• - Create and review project metric reports, status updates, study progress to Lead DM in order to share information on site performance issues, data trends and protocol non-compliance
• - Support and conduct Quality Review checks during study. As lead DM, may organize and lead Quality Review activities
• - Assist in contracts negotiation and contracting process with vendors (EDC, IRT, eCOA)
• - Manage the database maintenance, lock and close-out processes and procedure
• - Participate in conference calls and/or meetings with vendors and sponsors
• - Recognize and solve potential problems and evaluate effectiveness
• - Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date
• - Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned
• - Help to align data management and clinical programming best practices, standards and conventions within the company
• - Propose and support initiatives for improving efficiency.