For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
Skills: Pharmacokinetics, Bioanalytical, Sample management, Logistics, Data analytics
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
Skills: Analytical Development, Quality Control, GMP, Drug Substance Development, Drug Product Manufacturing
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
Skills: KOL Engagement, Scientific Exchange, Relationship Building, Strategic Thinking, Speaker Program Management
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
Skills: Sales Strategy, Team Management, Clinical Acumen, Market Data Analysis, Cross-functional Collaboration
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
Skills: Team Leadership, Field Reimbursement Management, Payer Reimbursement Landscape, Hub Operations, Specialty Pharmacy Models
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
Associate Director, Field Reimbursement Excellence & Flexible Support (Endocrinology)
United States · Remote OK
$172k–$228k/yr
Senior$119M raised
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
Associate Director, Human Resources Generalist - Europe (Contract)
Berlin, Germany · On-site
Senior+$119M raised
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
Skills: Medical Safety Leadership, Pharmacovigilance, Benefit-Risk Assessment, Signal Evaluation, Oncology
Director, Product and Pipeline Communications (Oncology and Neurology)
Redwood City, California, United States · On-site
$239k–$281k/yr
Senior+$119M raised
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
Skills: Strategic Communications, Media Relations, Content Planning, Social Media Strategy, Executive Communications
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
Skills: Thought Leader Engagement, Product Launch, Speaker Bureau Management, Gynecologic Oncology, Commercial Strategy
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
Skills: Signal Detection, Risk Management, Pharmacovigilance, Safety Data Analysis, Aggregate Reporting
Redwood City, California, United States · Remote OK
$172k–$228k/yr
Senior$119M raised
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
Skills: Veeva PromoMats, Veeva MedComms, Regulatory Operations, Content Review Process, FDA Form 2253 Submissions
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
Skills: Biostatistics, Clinical Trial Design, CRO Management, SAS, R
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
Skills: Biostatistics, Clinical Trial Design, CRO Management, SAS, R
Associate Director, Europe Business Analytics & Insights
Munich, Bavaria, Germany · On-site
Senior+$119M raised
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
Skills: Commercial Analytics, Business Insights, Data Science, Statistical Modeling, Market Access
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$101k–$119k/yr
Full-time
high school, bachelor degree
Posted 13d ago
~40 hrs/week
Responsibilities
The specialist will manage global PK and bioanalytical sample logistics, ensuring accurate tracking from clinical sites to testing facilities. They will also coordinate with vendors, maintain documentation for the Trial Master File, and support the development of standard operating procedures.
Requirements
Candidates must have at least 3 to 5 years of relevant experience in PK sample management and a solid understanding of GxP regulations. Proficiency in Microsoft Office and experience with clinical database systems like IRT are required for this role.
Full job description
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases.
Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.
Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com.
This position, reporting to the Associate Director of Data Analytics and Systems Development, will assist and support global PK and BioAnalytical (BioA) operations, sample and vendor management, and logistics activities for the PK department. This role is responsible for tracking PK/BioA samples at the investigaitonal site(s) (no sample left behind). This role will work cross funcitonally with the Clinical Operations department to oversee logistics from the clinical sites to Central labs, from Central labs to BioA testing sites, and/or long term storage facility. Generating PK sample reports for each clinical program, coordinating with vendors, and attending vendor meetings, as applicable, are examples of cirtical duties of this position. This role will also support non-clinical PK logistics as needed.
Responsibilities:
Track and coordinate clinical investigational PK site shipments to ensure timely deliveries while meeting quality and regulatory requirements
Work cross-functionally with Clinical Operations to support all clinical programs that have PK sample management requirements
Assist in the preparation and tracking of all global logistics of Reference Standards, and PK sample movements
Collect and organize PK sample documents to support filing into Corcept’s electronic Trial Master File system
Review and summarize PK sample temperature recorder data to ensure data are archived in a timely manner and saved to the proper TMF index
Manage PK sample long term storage
Assist in drafting or revising PK and sample management SOPs
Communicate with external vendors and internal customers as needed
Work cross functionally to achieve company goals
Preferred Skills, Qualifications and Technical Proficiencies:
Excellent interpersonal, verbal and written communication skills are keen in this collaborative, dynamic environment
Organizational skills and ability to prioritize effectively to deliver results within established timelines
Strong attention to detail and proactive follow-up is highly desirable
Ability to interpret a variety of instructions furnished in written or verbal format
Comfortable in a fast-paced small development company environment
Proficient in Microsoft Outlook, Word and Excel
Preferred Education and Experience:
High school degree and at least 5 years of related experience; or, a bachelor’s degree in related discipline and at least 3 years of related experience
Additional qualification or experience in PK sample management
Knowledge of GxPs and familiarity with US and EU regulations
Knowledge of drug development process
Experience with Interactive Responses Technology (IRT) Systems and other databases
Experience in Microsoft Office applications, Pivot charts, Lucid chart, Swimlane and Smartsheet
The pay range that the Company reasonably expects to pay for this headquarters-based position is $101,300 – $119,200; 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.
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.
Pioneering the discovery and development of cortisol modulators.
Industry
Biotechnology Research
Company size
501-1,000 employees
Founded
1998
Headquarters
Redwood City, California
LinkedIn followers
73,870
Total funding
$119M
We’ve been unlocking the potential of cortisol modulation for more than 25 years.
We’re 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 a groundbreaking cortisol receptor blocker and 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.
Offices: 101 Redwood Shores Pkwy, Redwood City, California 94065, US
Pioneering the discovery and development of cortisol modulators.
Industry
Biotechnology Research
Company size
501-1,000 employees
Founded
1998
Headquarters
Redwood City, California
LinkedIn followers
73,870
Total funding
$119M
We’ve been unlocking the potential of cortisol modulation for more than 25 years.
We’re 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 a groundbreaking cortisol receptor blocker and 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.
Offices: 101 Redwood Shores Pkwy, Redwood City, California 94065, US