Sr. Manager, Clinical Packaging & Labeling
- Corcept Therapeutics
- Menlo Park, CA
- Start date
- Mar 26, 2023
- Clinical, Clinical Research, Manufacturing & Production
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Biotech Bay
Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe endocrine, metabolic, oncologic and neurological disorders by modulating the effects of the hormone cortisol. Since 2012, we have marketed Korlym® for the treatment of patients suffering from Cushing’s syndrome, a life-threatening orphan disorder caused by excess cortisol activity. In 2022, we generated revenue of $402 million and net income of $101 million.
We have discovered a portfolio of more than 1,000 proprietary selective cortisol modulators. Our lead compounds are in Phase 2 and Phase 3 trials for the treatment of patients with Cushing’s syndrome, advanced ovarian cancer, castration-resistant prostate cancer and amyotrophic lateral sclerosis (“ALS”). We plan to initiate a Phase 2b trial in patients with non-alcoholic steatohepatitis (“NASH”) by the end of this year. Every year, we advance new molecules to the clinic.
Over the next few years, we expect to submit several new drug applications.
As Sr. Manager, Clinical Packaging & Labeling, you will be responsible for packaging, labeling, and IRT activities to ensure continuous drug supply to all global clinical trials. This position will report to the Director, Supply Chain.
- Manage packaging and open/blinded labeling to ensure the timely release of drug supply for Corcept’s global clinical trials
- Manage clinical drug supply in IRT, including expiry extensions, release of newly packaged drug, and depot transfers
- Ensure inventory levels are maintained at depots and sites
- Partner with key stakeholders (eg. Quality Assurance, Clinical Operations, Regulatory Affairs) and CMO’s to ensure the timely release of drug supply
- Develop and implement appropriate Supply Chain SOPs
- Generate effective tracking tools and performance metric reports
- Lead periodic production schedule meeting
- Domestic or international travel may be required
Preferred Skills, Qualifications and Technical Proficiencies:
- Working experience with global clinical trials and IRT systems is a must
- Working knowledge of cGMPs and familiarity with US and EU regulations
- Working knowledge of drug development process (Phase I-IV)
- Excellent interpersonal, verbal, and written communication skills are essential in this collaborative, fast-paced, dynamic environment
- Excellent organizational skills and an ability to prioritize effectively to deliver results within established timelines
- Strong attention to detail with excellent follow-up
- Proficient in Microsoft Outlook, Word, Excel, PowerPoint
Preferred Education and Experience:
- BS/BA degree in Life Science or a closely related field
- 6-8 years of experience in a pharmaceutical or biotechnology company
- ASCM CPIM/CSCP certifications preferred
The pay range that the Company reasonably expects to pay for this position is $135,000 - $170,000; the pay ultimately offered may vary based on legitimate considerations, including job-related knowledge, skills, experience, and education. An annual cash bonus and equity grants may be provided as part of the overall compensation package, in addition to a full range of medical, financial, and other wellness benefits, dependent on the position offered.
Applicants must be currently authorized to work in the United States on a full-time basis.
If you are based in California, we encourage you to read this important information for California residents linked here.
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 is leading the discovery and development of drugs that modulate the effects of cortisol.
Cortisol dysregulation plays an important role in a variety of endocrine, metabolic, oncologic, psychiatric, and ophthalmologic diseases. Corcept leads the field in the research and development of selective glucocorticoid receptor (GR) antagonists, having discovered more than 500 proprietary molecules since being founded in 1998.
Corcept is committed to improving patient lives through the discovery and development of drugs that address serious unmet medical needs related to excess cortisol activity. To support this mission, Corcept collaborates with numerous basic scientists and clinical researchers to find better ways to improve patient lives.
Through our collaborations with researchers around the world, more than 30 studies are underway to investigate the potential benefits GR antagonists may have in the treatment of serious and life-threatening diseases driven by cortisol dysregulation.
Stock Symbol: CORT
149 Commonwealth Drive
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