Director/Senior Director of Pharmaceutical Development

SUMMARY

Reporting to the Head, CMC and Analytical Development, the Director/Senior Director of Pharmaceutical Development is an experienced pharmacist/chemist with a broad knowledge of drug development.  The Director/Senior Director of Pharmaceutical Development will support the achievement of operational objectives within CMC/Pharmaceutical Development, ensuring alignment to Trevena company strategy and objectives. 

Specifically, the Director/Senior Director of Pharmaceutical Development will be responsible for:

  1. Drug product formulation development and process development, including evaluation of physical characteristics of development API (solubility, particle size, etc.), evaluation of early clinical and non-clinical data (pK, tox., etc.) and stability data (potency, impurity/degradants, etc.) of lab scale/pilot scale batches and adjustment of processes and methods, as needed,
  2. Working within the team to identify and qualify vendors and third-party manufacturers,
  3. Manufacturing of non-GMP and GMP batches, including batches to support clinical trials,
  4. Oversee the labeling and distribution of clinical trial materials,
  5. Leading/managing the DOE study to finalize the DP process and process validation,
  6. Developing/implementing strategies to reduce the COGS of drug product,
  7. Preparation of CMC documents related to clinical trial applications and providing technical support for NDA and sNDA filings,
  8. Selection and management of contractors executing CMC activities – including development work, process scale-up and CTM manufacturing,
  9. Collaboration with internal Quality and Compliance department to assure that CROs are performing according to cGMPs,
  10. Interaction with analytical and drug substance CMC team members to build the CMC development plan and ensure execution thereof,
  11. Representing the CMC team in the cross-functional development team(s),
  12. Observes all Trevena policies, SOPs and safety guidelines,
  13. Other duties as assigned.

TRAVEL REQUIREMENTS

Up to 10% domestic/international travel.

EDUCATION & EXPERIENCE

  1. PharmD, PhD in chemistry, related/equivalent qualifications,
  2. 10+ years of experience working in drug development, especially in drug product development/upscaling,
  3. Experience in the preparation of drug product development reports for the CMC section of IND/IMPD and/or NDA submissions,
  4. Experience working in a virtual organization and managing CROs,
  5. Experience with sterile injectable, solid oral, and alternative dosage forms.

KNOWLEDGE, SKILLS & ABILITIES

  1. Strong knowledge of functional area,
  2. General understanding of related functional areas,
  3. Ability to ensure alignment of methods, techniques and functional objectives with company strategy and organizational objectives,
  4. Demonstrated understanding of drug development including knowledge of drug discovery, clinical trials, and regulatory requirements for INDs, IMPDs, and NDAs,
  5. Strong analytical skills with a demonstrated ability to think strategically,
  6. Deep knowledge of physical properties, pharmacology, clinical trial supply,
  7. Strong problem-solving skills with a track record of identifying and implementing novel solutions,
  8. Solid negotiation skills in quotation and a persuasive project management style when working with CMO/CRO to achieve company’s business and technical objectives,
  9. Transparent and direct communication styles internally and externally,
  10. Able to work in a fast-pace and constantly changing working environment.

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Accepted formats: PDF, Word Doc

Accepted formats: PDF, Word Doc