Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.

In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing’s syndrome).

Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation.

What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.

The Associate Director of Formulation Development will support the drug product development function. Responsibilities will include leading, planning and managing the technical and business-related activities associated with drug product development and manufacturing of solid oral dosage forms at contract development sites.

Responsibilities:

Use knowledge and experience to design and select appropriate formulations for toxicology and first in human studies
Support formulation and process development, technology transfer and clinical manufacturing activities
Develop strategies and execute plans for drug product development in accordance with timelines and requirements of overall development programs
Select and manage contract development and manufacturing vendors
Negotiate and approve statements of work and quotes
Review and approve manufacturing documents, protocols and reports
Work closely with other internal functional groups to ensure that all drug product requirements for clinical trials are met
Work closely with QA to ensure clinical supplies meet quality requirements
Prepare CMC sections of regulatory filings.
15-20% travel expected

Preferred Skills, Qualifications and Technical Proficiencies:

Technical expertise in solid oral dose formulations for small molecules
Must have hands-on experience in formulating drugs with limited solubility and is knowledgeable about technologies employed to enhance bioavailability
Must have experience in formulation and process development from early to late phase development
Solid understanding of ICH, FDA, EMA guidance in CMC and Quality areas
Good working knowledge of GMP requirements for drug product development and manufacturing
Experienced in writing CMC sections of regulatory filings
Strong written and oral communication skills. Must be comfortable making presentations in team meetings and must have the ability to communicate complex technical information clearly and concisely
Good project management and leadership skills, with ability to lead multiple programs at the same time
Enjoy working in a fast-paced environment within a matrix organization

Preferred Education and Experience:

PhD in Pharmaceutical Sciences or relevant technical field with 6-8 years experience or MS with 10+ years experience.
Minimum of 5 years in managing outsourced drug product development activities

The pay range that the Company reasonably expects to pay for this headquarters-based position is $181,000 - $213,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

Applicants must be currently authorized to work in the United States on a full-time basis.

For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.

Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.

Please visit our website at: https://www.corcept.com/

Corcept is an Equal Opportunity Employer

Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.

Compensation Overview

6 month growth

1 year growth

2 year growth