Associate Director – Clinical R&D

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About the job

Do you have clinical development experience in generics/specialty pharmaceuticals in dosage forms such as inhalation, topical and complex injectables? Would you love the opportunity to work with a privately-owned growing, global generics pharmaceutical company working on a robust pipeline of complex generic products?

Invenia Group is partnered with a global organization producing high-quality medicines for those in need. We are now looking to hire an Associate Director – Clinical R&D for the company’s fast-growing team. This is a fantastic opportunity to join an international organization with an abundance of successful partnerships around the world.

Role responsibilities: 

If successful, you will be responsible for assessing the viability of generics and ideas from a clinical R&D outlook. You will provide clinical expertise pertaining to study design, planning, and execution of PK/PD and/or phase studies for complex generics and products that include combination products such as inhalation and injectable products, as well as the following:

  • Ensures each project has a robust clinical program and adheres to GCP, GLP, and all applicable regulatory guidelines
  • Monitor changes/updates made to guidance documents related to Clinical studies/BE studies and implementation
  • Partner with Regulatory Affairs for FDA discussions and authoring submissions to ensure successful execution of complex generics and 505(b)(2) programs
  • Collaborate with R&D during product development to provide guidance on PK issues, developing bio-relevant dissolution, PK modeling, simulations, WinNonlin, and IVIVC/IVIVR models
  • Collaborate extensively with portfolio and business development and provide scientific feedback and clinical plans for identifying and developing new products through in-licensing or due diligence efforts
  • Works cross-functionally and with external partners to select clinical study designs to align with company objectives
  • Works with Regulatory in the filing of applications and responding to deficiencies
  • Identification and selection of CROs for clinical and non-clinical studies (eg. toxicity studies, immunogenicity studies, etc

What we are looking for: 

We are looking for someone with a Ph.D. or Masters’s degree in a scientific discipline, with a minimum of 10 years of experience in the conduct of PK/PD and/or Phase 3 clinical endpoint studies. You should have experience in generic/specialty pharmaceutical companies on a variety of dosage forms, as well as thorough knowledge and understanding of scientific principles applicable to product development and implementation.

Sound interesting? To find out more information regarding this exciting opportunity, please apply.