Program & Project Management

Drug Development Professionals (DDP) specializes in providing top-tier Project Management support to drive success in your drug development programs. Our Project Management support services are designed to provide you with the expertise and flexibility needed to navigate the complexities of drug development. Partner with us to ensure your projects are delivered on time, within budget, and with the highest quality standards. Here’s how we can support your organization:

PROGRAM MANAGEMENT

Our Project Managers provide strategic oversight and coordination of drug development program activities. Specific tasks include:

  • Facilitate cross-functional team collaboration and communication.
  • Define program goals, objectives, and success criteria.
  • Develop and maintain integrated project plans and timelines.
  • Manage program budgets, resources, and risks.
  • Conduct regular progress reviews and status updates with stakeholders.
  • Driving continuous improvement and process optimization initiatives.

RESOURCE MANAGEMENT

DDP has extensive resource management expertise and helps biopharmaceutical companies manage their most valuable assets…its people. Specific tasks include:

  • Work with executive teams and department heads to forecast future resource needs based on R&D pipelines and project-specific timelines.
  • Coordinate personnel allocations across departments to align resource availability with corporate objectives.
  • Monitor team capacity to ensure resources are utilized effectively without overburdening staff.
  • Generate reports and visualizations for leadership.
  • Identify gaps, optimize processes, and streamline workflows.
  • Support the selection and implementation resource management software or tools.

CMC PROJECT MANAGEMENT

Our CMC project managers ensure that pharmaceutical products are manufactured and controlled effectively, meeting both regulatory requirements and business objectives. Specific tasks include:

  • Develop and maintain CMC project timelines, track progress, and ensure on-time delivery of key milestones, including scale-up, technology transfer, and commercial readiness.
  • Monitor budgets, allocate resources, and ensure cost-effective delivery of CMC milestones.
  • Act as the central point of communication between teams like R&D, manufacturing, regulatory, quality assurance, and external vendors.
  • Identify potential risks in manufacturing and controls processes and implement mitigation strategies to avoid delays.
  • Managing post-approval changes, such as manufacturing site transfers, process optimizations, or raw material changes, while ensuring compliance.
  • Coordinate with external contract development and manufacturing organizations (CDMOs) and vendors for CMC-related activities.

CLINICAL PROGRAM MANAGEMENT

Our Clinical Program Managers provide project management support to reduce the workload on study teams and ensure the smooth execution of clinical trials. Specific tasks include:

  • Develop and manage detailed study plans and timelines.
  • Prepare study status reports and provide timely updates to executive leadership teams.
  • Coordinate interactions between study teams, internal stakeholders and external partners.
  • Facilitate vendor selection processes and provide oversight of deliverables.
  • Prepare study budgets and reconcile vendor invoices.
  • Identifying and mitigating risks to keep projects on track.

REGULATORY AFFAIRS

Our Regulatory Project Managers help keep your submissions and regulatory activities on track and on time! Specific tasks include:

  • Lead cross-functional teams to create regulatory strategies for new drug applications, clinical trials, and product approvals.
  • Oversee the preparation, review, and timely submission of regulatory documents (e.g., IND, NDA, BLA, MAA).
  • Track regulatory milestones and ensure the timely delivery of regulatory obligations.
  • Coordinate meetings with regulatory agencies, respond to queries, and provide status updates.
  • Manage post-approval changes, including manufacturing updates, labeling revisions, and market expansion efforts.

MEDICAL AFFAIRS

In the realm of Medical Affairs, our project managers bridge the gap between clinical research and commercial functions. Specific tasks include:

  • Coordinate cross-functional teams, timelines, and deliverables to support product launches.
  • Manage the development, review, and approval of medical publications and scientific communications.
  • Facilitate advisory boards and key opinion leader (KOL) engagements.
  • Ensure medical education programs and training initiatives are in alignment with corporate, legal, and regulatory compliance standards.
  • Coordinate, track, and report on the status of Investigator Initiated Studies (IIS)
  • Track and organize post-marketing data to inform future strategies.

LAUNCH PLANNING & COMMERCIAL PRODUCT LIFECYCLE MANAGEMENT

DDP’s Product Managers provide a broad range of support services that ensure the success of your commercial products. Specific tasks include:

  • Lead cross-functional teams to develop and execute launch strategies for new biopharmaceutical products.
  • Ensure stakeholder collaboration with R&D, regulatory, medical affairs, and manufacturing teams to align on product strategies.
  • Collaborate with market access teams to develop pricing strategies and ensure reimbursement pathways are in place.
  • Facilitate interactions and communications with key stakeholders, such as healthcare providers, payers, and patient advocacy groups.
  • Work with supply chain teams to forecast demand and ensure sufficient product availability.
  • Manage the commercial aspects of the product throughout its lifecycle, including line extensions and market expansions.