Clinical Project Manager.

Project Manager

Key Responsibilities:

• Lead and manage projects involving

  NCE development

  , from pre-formulation through formulation and process development.
• Develop, monitor, and maintain project timelines, budgets, and resource allocation.
• Collaborate with

  R&D, Analytical, Regulatory, Quality, and Manufacturing teams

  to ensure seamless project execution.
• Oversee

  pre-formulation studies

  , including solubility, stability, excipient compatibility, and solid-state characterization.
• Guide

  formulation development activities

  for oral, injectable, or other dosage forms.
• Ensure compliance with

  cGMP, ICH, and regulatory guidelines

  throughout project execution.
• Identify potential risks, develop mitigation strategies, and proactively resolve project-related challenges.
• Prepare and present project updates, progress reports, and technical data to senior management and stakeholders.
• Serve as the primary liaison between internal teams, external partners, and CRO/CMO collaborators.
• Drive continuous improvement in project management processes and contribute to organizational best practices.

Qualifications

• Master’s or Ph.D. in

  Pharmaceutics, Pharmaceutical Sciences, Chemistry, or related field

  .
• 7+ years of experience in

  pharmaceutical R&D

  , with proven expertise in

  pre-formulation and formulation development

  .
• Strong understanding of

  drug development lifecycle

  , from discovery to clinical trials.
• Experience in managing cross-functional teams and external CRO/CMO partners.
• Excellent knowledge of

  analytical techniques

  , stability studies, and biopharmaceutics.
• Demonstrated ability to manage multiple projects, set priorities, and deliver results on time and within budget.
• Strong leadership, communication, and organizational skills.
• Familiarity with regulatory submission requirements (IND, NDA, ANDA, IMPD) is a plus.

Preferred Skills

• Experience with

  oral solid dosage forms, injectables, or biologics formulation

  .
• PMP certification or formal project management training.
• Experience with

  QbD (Quality by Design)

  and

  DoE (Design of Experiments)

  approaches in formulation development.