We are seeking a Head of Drug Formulation (Director to Senior Director) to lead internal and external activities related to formulation development for research and development projects. The successful candidate will be responsible for leading the development of formulations for preclinical and clinical studies. The ability to bring a sense of urgency, to drive for results, work effectively in a collaborative, interdisciplinary team environment is essential to this role with the expectation that this scientist will interact with all disciplines of drug development, including discovery, pre-clinical, clinical, pre-formulation, analytical R&D, and regulatory. Experience working directly on small molecule agents and previous involvement with contributing to the filing of one or more INDs is required.
Kymera Therapeutics is a biotechnology company with an exciting platform technology representing a transformative new approach to treating previously untreatable diseases. Our technology is based the promising field of Targeted Protein Degradation, in which the body’s innate protein recycling machinery is accessed to degrade rather than inhibit dysregulated, disease-causing proteins. Kymera has multiple un-partnered programs in Oncology and Immunology/Inflammation, with plans to enter the clinic in early 2021. We also have an exciting and validating collaboration with partner Vertex Pharmaceuticals focused on several other new disease areas. Kymera just recently completed a significantly over-subscribed Series C financing totaling over $100 million, creating a multi-year cash runway.
We are based in Technology Square in Cambridge until our move to newly built offices at the Arsenal Yards development in Watertown in July 2020. Our offices will have free parking and a free transportation shuttle from Harvard Square running every 15 minutes during commute hours.
- As a key member of the preclinical development team, the Head of Formulations will be responsible for leading efforts across multiple R&D teams to design formulation strategy and develop formulations and drug product for toxicology and clinical studies
- Work with research teams to develop fit-for purpose early formulation to support in vivo (pharmacology, DMPK) studies.
- Work with chemistry and DMPK stakeholders to ensure formulation as key aspect of compound optimization and candidate selection.
- Identify collaborators, CROs, and state-of-the-art new technologies to enable the Kymera pipeline.
- Responsible for the technical and regulatory aspects of formulation development.
- Manage interactions with external CROs to ensure high quality and on-time execution.
- Communicate program updates and status effectively, both internally and externally.
- Author scientific manuscripts and regulatory documents.
- PhD. degree in Pharmaceutics, Physical Pharmacy, Chemical Engineering, or Pharmaceutical sciences with at least 10 years relevant pharmaceutical industry experience. A candidate with a Master degree in a relevant field and extensive industrial experience will be also considered.
- In-depth understanding of pre-formulation, clinical formulation, biopharmaceutics principles required to get a drug from discovery through clinical development is required.
- A driven individual who has a demonstrated track record of proactively identifying problems and driving to timely, innovative solutions to overcome challenging formulation problems
- Experience in applying a diversity of formulation technologies to improve solubility and bioavailability of poorly water-soluble drugs is preferred.
- Industrial experience in oral, parenteral, or other dosage form development
- Experience as lead formulation scientist on multiple successful INDs and early development projects.
- Demonstrated experience in leading relevant interactions with regulatory agencies is required
- Experience in developing commercial drug product and supporting NDA is a plus.
- Excellent communication skills, problem solving, critical thinking, and organization skills. Ability to work in a fast-paced organization with diverse project teams and personnel.
- Strong scientific expertise, demonstrated by published scientific articles in peer-reviewed journals, society participation, regulatory filings and patents. Proficient in using computer to write and review technical reports and scientific judgment in data evaluation.
- Knowledge in pharmaceutical product development, CMC regulatory requirements, project management; and capability to collaborate with colleagues