Clinical Project Manager

10 hours ago

Pacific Remote Islands Marine National Monument, India TruMinds Clinical Full time

Position Overview

We are seeking a highly motivated and experienced Project Manager with a strong background in new chemical entities (NCEs), pre-formulation, and formulation development. The ideal candidate will manage cross-functional drug development projects from early discovery through clinical development, ensuring timely execution, compliance, and alignment with strategic goals.

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.

Job Type: Full-time

Pay: ₹1,200, ₹1,600,000.00 per year

Experience:

  • NCE development: 4 years (Required)
  • Pre-formulation studies: 4 years (Required)
  • formulation development activities: 4 years (Required)

Work Location: Remote

Speak with the employer

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