Director Clinical Development

3 weeks ago

Watertown, United States Integration International Inc. Full time

Job Description::

  • The Senior Director, CMC Formulation will design, execute, and lead pre-clinical and clinical formulation development efforts and associated manufacturing in the development of solid/liquid oral dosage forms for use in clinical studies and potential commercialization. T
  • he Sr. Director will serve as a technical expert in the formulation development and manufacturing throughout the organization and will coordinate/author/review drug product relevant sections of regulatory documents.
  • In addition, the successful candidate will oversee the selection, tech transfer and execution of drug product development and manufacturing plans at external partners.
  • The candidate must have extensive knowledge and hands on experience on equipment’s and processes commonly used for solid and liquid oral formulation development. This position reports to the Vice President, CMC.


Primary Responsibilities


  • Serve as the scientific leader in formulation, develop strategic formulation development plans in alignment with our clinical trial plans and company goals. Design phase appropriate formulations at different stage of development (preclinical to clinical phase III)
  • Manage project assignment and work distribution for formulation team
  • Designs and executes pre-clinical and clinical formulation development experiments to develop and support solid and liquid oral dosage form products.
  • Conducts physicochemical characterization of different drug substance lots as needed.
  • Technical expertise in solid/liquid oral dosage form development and scale-up.
  • Work in close collaboration with the Project and CMC teams and related functions, including discovery, non-clinical development, process development, analytical development, Quality and Regulatory teams.
  • Identify and select CDMO’s for drug product development and manufacturing.
  • Manages formulation development and clinical manufacturing activities at external laboratories and manufacturing facilities.
  • Authors and reviews formulation related sections for regulatory filings, development reports and other development related documents.
  • Actively communicates, collaborates with and contributes to other functional areas to solve problems and achieve goals.
  • Oversee tech transfer and future validation of drug product manufacturing processes.
  • Oversee and manage CDMOs including authoring and reviewing of Batch Records/Master Production Records and specifications.
  • Some travel (10-20%) required for this position.


Qualifications

  • Advanced degree (PhD preferred) in pharmaceutical science, chemical engineering or related scientific field with 12+ years industrial drug product development experience.
  • The successful candidate has demonstrated leadership in managing people, multiple projects, and budget.
  • The successful candidate has a strong understanding of formulation and CMC development.
  • A proven track record in developing and scaling up formulations for oral administration from pre-IND through late-stage development.
  • Experience and expertise in formulation development of poorly soluble (BCS Class II/IV) compounds (small molecules).
  • Extensive knowledge and hands on experience with equipment and processes commonly used for solid and liquid oral formulation development.
  • Working knowledge and know-how to support preclinical studies with variety of formulation approaches and delivery routes.
  • Working knowledge of methods and instrumentation used for the characterization of solution and solid-state properties of materials.
  • Background in applying statistical approaches in the design and analysis of experiments and experience with Quality by Design (QbD) is preferred.
  • Responsible for managing form selection/characterization, pre-formulation, formulation development, delivery of clinical supplies, development of efficient and scalable manufacturing processes.
  • Excellent verbal and written communication skills, ability to effectively work across levels, functions and companies.
  • Author and review drug product sections in the CMC sections of regulatory submissions, internal and vendor reports.

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