We are seeking a highly skilled and experienced Director of Health Economics and Outcomes Research (HEOR) with a strong focus on Oncology to join our team. The ideal candidate will play a critical role in leading and shaping the global HEOR and evidence strategy across both pipeline and launched oncology products to inform regulatory decision making and drive market access, reimbursement, and lifecycle value management globally.

This position involves working cross-functionally with Medical Affairs, Market Access, and Clinical Development to ensure alignment between evidence generation and strategic objectives. This role offers the opportunity to drive scientific leadership and innovation, developing new methodologies and evidence strategies to enhance the understanding of the value of oncology treatments and advance the organization’s mission of delivering life-changing therapies to patients worldwide.

Responsibilities:

• Execute integrated global HEOR strategies across pipeline and marketed oncology products, ensuring alignment with regulatory, market access, and reimbursement requirements across key geographies
• Contribute to and drive execution of end-to-end evidence generation plans across the product lifecycle, integrating clinical, economic, and real-world evidence to support value demonstration and access
• Execute and oversee the development of ex-US value Dossiers, ensuring alignment with clinical, economic, and epidemiologic evidence to support payer and HTA requirements
• Oversee the design and execution of real-world and observational studies (e.g., retrospective studies, prospective cohorts, registries) to generate evidence on effectiveness, safety, treatment patterns, and healthcare resource utilization
• Lead the development and adaptation of cost-effectiveness and budget impact models, ensuring alignment with global and local market access strategies and payer expectations
• Lead the design and execution of indirect treatment comparisons, external control analyses, and other comparative effectiveness approaches, ensuring methodological rigor and alignment with HTA expectations
• Oversee the development of systematic literature reviews and evidence syntheses to support HTA submissions, modeling inputs, and broader evidence strategies
• Provide strategic input into HTA submissions and payer engagement, ensuring that evidence packages address key uncertainties and support favorable reimbursement outcomes in global markets
• Drive innovation by advancing methodological approaches in health economics, epidemiology, and outcomes research, including novel frameworks to support value demonstration
• Identify and leverage appropriate real-world data sources (e.g., EHR, claims, registries) and establish external partnerships to support timely and high-quality evidence generation
• Develop and deliver clear, data-driven insights to internal leadership and external stakeholders, supporting alignment on the value proposition of oncology therapies
• Demonstrate strong leadership across cross-functional and cross-regional teams, fostering collaboration and driving high-quality, timely execution
• Uphold Corcept’s Key Principles by driving Collaboration, Embracing Possibility, Following the Data, and Leading by Doing, ensuring all initiatives align with the company’s ethics and patient-first mission

Preferred Skills, Qualifications and Technical Proficiencies:

• Proficiency in advanced statistical and modeling techniques for economic evaluation (e.g., Markov models, decision trees, cohort simulations)
• In-depth knowledge and ability to apply knowledge of US and global healthcare systems, global HTA requirements, and clinical development, to identify evidence gaps and formulate evidence generation and communication strategies
• Generate peer-reviewed publications to communicate study findings in scientific channels in alignment with the product publication strategy and the overall HEOR evidence generation strategy
• Expertise in the preparation and delivery of high-quality, evidence-based health economic reports and presentations to stakeholders at various levels (internal teams, HTA bodies, payers)
• Strong project management skills, with the ability to manage multiple priorities and deadlines
• Excellent communication and presentation skills

Preferred Education and Experience:

• Advanced degree (PhD, MSc, or equivalent) in health economics, public health, health policy, statistics, or a related field. A focus on oncology is highly desirable
• 10+ years of experience in HEOR, with a strong background in oncology
• Demonstrated ability to lead cross-functional initiatives and influence senior stakeholders
• Proven experience in global HEOR strategy, HTA submissions, and payer engagement
• Strong expertise in health economic modeling, RWE, and comparative effectiveness research
• Demonstrated expertise in indirect treatment comparisons, real-world evidence generation, and observational study designs (e.g., registries)
• Strong understanding of US & EU healthcare systems, reimbursement pathways, and payer requirements
• Strong communication and presentation skills, with the ability to translate complex data into actionable insights
• 15% with travel as required

The pay range that the Company reasonably expects to pay for this position is $209,100 - $276,800; 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.

The Associate Director, Supply Chain (Commercial) will be accountable for end-to-end supply planning to support portfolio growth, future indications and geographic expansion within Corcept’s fully outsourced manufacturing network. This role owns the integrated demand and supply plan for assigned programs, translating commercial forecasts into scalable, risk-balanced supply strategies across drug substance, drug product, packaging and distribution. The position partners cross-functionally with Commercial, Regulatory, Manufacturing, Quality and Finance ensuring uninterrupted supply, launch readiness and lifecycle continuity.

This is a hybrid role typically requiring on-site presence at 3 days per week. This position may require ~10–15% travel.

Responsibilities:

• Own supply planning and strategy for assigned products and programs across launch, growth, and lifecycle phases, including future indications and geographic expansions
• Develop and maintain integrated, multi‑year supply plans aligned with commercial forecasts, regulatory timelines, capacity constraints, and inventory objectives
• Translate demand forecasts into manufacturing, packaging, and distribution requirements for drug substance, drug product, and finished goods
• Lead scenario planning and risk assessments related to demand growth, indication and geographic expansion, inventory, capacity limitations, and supply chain dependencies
• Support launch and expansion readiness by aligning supply plans with regulatory filings, stability strategies, shelf‑life considerations, and country‑specific requirements
• Partner with Manufacturing, Quality, Finance and external CDMOs to assess and shape capacity, lead times, yields, and the impact of process or volume changes
• Contribute supply insights to S&OP / IBP, portfolio, and governance forums; clearly communicate risks, tradeoffs, and mitigation plans to senior leadership
• Proactively identify supply risks and develop mitigation strategies, including inventory positioning, alternate sourcing, and planning cadence adjustments
• Support continuous improvement of commercial supply planning processes, tools, and decision frameworks as the portfolio and commercial footprint expand
• Drive continuous improvement in service, compliance, and cost
• Monitor and report KPIs for contract service providers

Preferred Skills, Qualifications and Technical Proficiencies:

• Prior experience supporting regulated commercial supply chains, including pre‑ and post‑approval changes
• Strong communication and stakeholder‑management skills, with ability to communicate and present cross-functionally
• Advanced Excel skills, including complex models for demand translation, inventory management, and scenario analysis
• Experience with supply planning systems, ERP/MRP, and forecasting or planning tools
• Working knowledge of S&OP / IBP processes and supply governance frameworks
• Solid understanding of inventory strategies, shelf‑life management, and supply risk mitigation within regulated environments
• Ability to synthesize data into clear, executive‑level communications and recommendations
• Ability to operate independently with program‑level accountability in a dynamic, growth‑oriented environment
• Bias toward action in risk mitigation and developing solutions

Preferred Education and Experience:

• Bachelor’s degree in supply chain management, logistics, life sciences, or equivalent experience
• 8+ years of experience in commercial supply planning, demand/supply planning, or pharmaceutical supply chain roles
• Experience working with externally sourced manufacturing and CDMO partners
• Strong understanding of pharmaceutical manufacturing processes, outsourced supply models, and supply chain lead‑time dynamics

The pay range that the Company reasonably expects to pay for this headquarters-based position is $180,900 – $212,800; 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.

The Associate Director, Supply Chain (Logistics) will lead Corcept’s global logistics operations from early-phase development through commercial distribution. This role is responsible for the compliant, efficient, and timely movement of research samples, APIs, drug substance (DS), drug product (DP), and finished goods across a global CDMO network within a GDP-regulated environment.

The position requires deep expertise in managing complex, small-scale and large-scale international shipments, while navigating customs, VAT, and tariff requirements. This position is highly cross-functional role supporting R&D, Manufacturing, Clinical, and Commercial teams ensuring timely, accurate and compliant material transfers.

This is a hybrid role typically requiring on-site presence at 3 days per week. This position may require ~10–15% travel.

Responsibilities:

• Lead logistics strategy and execution, ensuring compliance with GDP and all applicable global regulations
• Ensure compliant import/export processes for a broad range of materials, from research samples to commercial products, and manage VAT implications for cross-border shipments
• Prepare and submit documentation for customs clearance, ensuring compliance with regulations and obtaining appropriate licenses or permits
• Liaise with government agencies and customs authorities to resolve issues
• Oversee tariff classification (HS codes), duty optimization, and correct valuation methodologies
• Lead vendor selection, qualification, and ongoing performance management for logistics providers
• Support qualification of shipping lanes and packaging systems
• Oversee temperature monitoring, excursion management, deviations and CAPAs
• Support onboarding of new partners by establishing logistics processes and compliance frameworks, as required
• Provide logistics input into planning processes, including supply planning and network strategy
• Develop SOPs and governance models for global logistics and material transfers
• Partner with R&D, Clinical Operations and Supply, Manufacturing, Quality, Regulatory Affairs, and Finance
• Drive continuous improvement in service, compliance, and cost
• Monitor and report KPIs for contract service providers

Preferred Skills, Qualifications and Technical Proficiencies:

• Strong knowledge of GDP and global distribution requirements
• Strong knowledge of customs laws and regulations
• Deep understanding of international shipping documentation, Incoterms, customs clearance, VAT, and tariffs
• Ability to operate independently in an ambiguous, fast-changing environment
• Effective communication and ability to influence across global teams
• Excellent problem-solving skills in time sensitive, high-risk scenarios

Preferred Education and Experience:

• Bachelor’s degree in supply chain management, logistics, life sciences, or equivalent experience
• 8+ years industry experience in global logistics within biotech, pharmaceuticals or life sciences
• Experience supporting clinical and commercial logistics operations
• Possession of a valid customs broker license preferred

The pay range that the Company reasonably expects to pay for this headquarters-based position is $180,900 – $212,800; 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.

Corcept Oncology is seeking an experienced and collaborative Associate Director, Digital & Commercial Analytics to lead next best action (NBA) orchestration and advanced analytics across marketing, and market access domains. This individual will co-lead the design, deployment, and monitoring of next best action (NBA) orchestration and deliver high-impact analytics across marketing performance, digital engagement, and market access. This role will work in close partnership with Digital Marketing, Commercial Operations, Market Access, IT, and external partners.

The ideal candidate brings strong experience in data-driven decisioning and orchestration platforms (e.g., Salesforce Marketing Cloud, CRM) and has operated in complex, matrixed commercial environments. While pharmaceutical experience is preferred, we are open to candidates from other industries with demonstrated expertise in decision sciences, personalization, and digital analytics.

Responsibilities:

Next Best Action (NBA) Strategy & Orchestration

• Co-lead the design, implementation, and ongoing optimization of next best action frameworks to support personalized, data-driven engagement across channels
• Define and maintain decision logic, business rules, and prioritization frameworks that translate analytics into actionable recommendations
• Partner closely with Digital Marketing to ensure alignment between NBA logic and channel execution (e.g., campaigns, journeys, content delivery)
• Oversee deployment and monitoring of NBA solutions within SFMC, SFDC, and related data and analytics ecosystems
• Establish performance measurement, monitoring, and continuous improvement processes for NBA effectiveness

Marketing Analytics & Insights

• Co-lead marketing analytics to evaluate campaign performance, omnichannel effectiveness, customer engagement, and ROI
• Analyze and interpret digital engagement data (e.g., channel performance, journey effectiveness, content interaction) to inform strategy, prioritization, and resource allocation
• Develop insights that inform segmentation, targeting, personalization, and future marketing strategy
• Collaborate with Digital Marketing and Commercial teams to translate insights into test-and-learn plans and optimization recommendations
• Ensure analytical rigor, consistency, and clarity in reporting and storytelling for senior stakeholders

Market Access Analytics

• Own and deliver market access analytics to support payer strategy, contracting, and access decision-making
• Analyze payer coverage, access dynamics, utilization management, and policy trends to inform strategic planning
• Partner with Market Access and Pricing teams to translate data into actionable insights and strategic recommendations
• Develop dashboards, analyses, and executive-ready materials to support cross-functional alignment

Cross-Functional Collaboration & Leadership

• Serve as a thought partner to Digital Marketing, Market Access, Commercial Operations, IT, and external vendors
• Ensure strong alignment between analytics, decision logic, and execution across teams
• Communicate complex analytical concepts clearly to technical and non-technical stakeholders
• Contribute to the overall growth and capability-building of the Market Intelligence & Decision Sciences function

Preferred Skills, Qualifications and Technical Proficiencies:

• Proven ability to operate effectively in cross-functional, matrixed environments
• Experience in the pharmaceutical or life sciences industry (commercial, marketing, or market access analytics)
• Familiarity with omnichannel engagement, digital measurement, and experimentation methodologies
• Experience partnering with IT teams and external vendors

Preferred Education and Experience:

• 10+ years of experience in decision sciences, marketing analytics, digital analytics, or related analytical roles
• Demonstrated experience designing and deploying next best action or decisioning frameworks
• Strong working knowledge of Salesforce Marketing Cloud (SFMC) and Salesforce  Data Cloud (SFDC)  
• Experience translating data and analytics into business-ready insights and recommendations

The pay range that the Company reasonably expects to pay for this headquarters-based position is $215,300 - $253,200; 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.

The Associate Director, Pipeline and Portfolio Market Planning is accountable for developing product strategies across Corcept’s oncology portfolio. This individual will guide indication selection and sequencing, competitive landscape assessments, target product profiles (TPPs), product proposition, and long-range financial forecasting to inform program-level decision-making.  

Responsibilities:

• Lead program-level strategy initiatives to define product vision, optimize lifecycle value, and drive business impact  
• Provide integrated physician, patient, and payer perspective in clinical strategy and new product planning initiatives 
• Own the design, implementation, and continuous refinement of competitive intelligence and market analysis frameworks that proactively inform program, investment, and governance decisions 
• Support cross-functional teams, including Commercial, Medical, Development, and Research, to ensure alignment and strategic continuity across the product lifecycle 
• Develop, maintain, and communicate long-range revenue forecasts and valuation models to support program planning and resource allocation 
• Synthesize market research, competitive intelligence, and secondary data sources into clear, actionable insights to guide cross-functional and leadership decision-making 
• Lead asset assessments and contribute to due diligence for potential business development opportunities 
• Manage ad hoc strategic projects, including global expansion initiatives in partnership with Emerging Markets team 
• Model Corcept’s key principles: collaborating effectively, embracing possibilities, following the data, and leading by doing 

Preferred Skills, Qualifications and Technical Proficiencies:

• Proven ability to lead and influence strategic planning efforts integrating scientific, clinical, commercial, and regulatory perspectives
• Deep understanding of the drug development process, spanning early through late-stage programs, with experience translating clinical insights into commercial strategy 
• Strong market research and analytical acumen with the ability to translate data into compelling executive-ready strategic recommendations 
• Experience operating effectively in a dynamic, matrixed environment, influencing stakeholders across R&D, Commercial, Medical, Finance, and Executive functions 
• Proven ability to rapidly synthesize information from multiple internal and external sources 
• Occasional travel required for corporate and industry events 

Preferred Education and Experience:

• Bachelor's degree required. Advanced degree preferred (MBA, MSc, PhD, PharmD)
• 8+ years of experience in new product planning, with relevant roles in market planning, business development, corporate strategy, investment banking and/or healthcare strategy consulting considered 
• Industry experience within oncology required 
• Prior experience working as part of or leading cross-functional drug development teams preferred 

The pay range that the Company reasonably expects to pay for this headquarters-based position is $215,300 - $253,200; 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.

The Senior Clinical Research Associate (Sr CRA) will independently manage all clinical aspects of a small to medium-sized clinical study or, with supervision, assume significant management responsibilities on a large-scale study. This position works closely with a cross-functional team, vendors, sites, and CRO (when applicable) to ensure compliance with protocol and the overall clinical objective. Additionally, this role will be responsible for implementing and monitoring clinical study activities to assure adherence to good clinical practices (GCPs), standard operating procedures (SOPs), and study protocols. This is a hybrid role typically requiring on-site presence at least 3 days per week.

Responsibilities:

• Serves as a crucial member of the project team for the quality execution of assigned clinical protocols according to Corcept’s SOPs, ICH/GCP, and corporate and departmental program goals
• Supports the Study Lead as an integral member of a multifunctional team to ensure clinical study activities including study start-up, enrollment, maintenance, and closeout are executed appropriately
• Participates in protocol development, tracking changes for future protocol amendments, and works with medical writing to create protocol amendments as needed
• Oversees some aspects of study management and vendors to ensure high quality of data
• Works with the in-house CTA to ensure the meeting agendas and meeting minutes are created, tracked, distributed, filed, and are accurate
• Participates in the review of study designs from an operations perspective, and site implementation tactics
• May support Study Lead in the review of CRO/Vendor RFPs and participate in bid defenses and review and comment on proposals for vendor selection
• Supports Study Lead in the development of study timelines and budgets per the corporate and departmental goals and continuously strives to ensure timelines and deliverables are met within budget
• Develops study processes in support of the protocol, develops workflow and resource plans to achieve interim goals; modifies according to study progress
• Escalates concerns regarding timelines, milestones, resourcing, and any potential study execution issue to the Study Lead
• Participates in the development of critical study documents such as informed consent form templates, site management, and monitoring tools
• Participates in the development, distribution, review, and tracking of essential trial documents
• Ensures essential documents are submitted to Regulatory for IND Updates and Amendments per the recommended timelines of the Study Lead
• Participates in the review and negotiation of site budgets and contracts
• Participates in the recruitment of potential Investigators suitable for a particular protocol
• Conducts sponsor oversight visits and may conduct site qualification visits and site initiation visits
• Participates in the development of and ensures compliance with the clinical monitoring plan; co-monitors as needed for staff training and quality assurance (QA) purposes
• Contributes to the case report form (CRF) design process including content, form layout, and edit check review
• Maintains a complete and updated regulatory file for each assigned site
• Supports aspects of study management to ensure high quality of data
• Liaises with chemistry, manufacturing, and controls (CMC) team to forecast and monitor overall drug supply and expiration to ensure adequate availability throughout the trial. May review site-specific accountability logs to ensure accuracy and report findings to Study Lead
• Supports other study-wide activities such as external vendors, sample handling, drug re-supply, investigator payments, overall data quality, and overall central records quality
• Serves as in-house contact for protocol-related process questions and reports in FAQs
• Participates in the evaluation of clinical study reports for accuracy, safety, and/or efficacy trends; as necessary for medical monitor review and/or IDMC meetings
• Exercises sound judgment to resolve or, as appropriate seek expert input on protocol and drug questions, safety, regulatory, and legal questions
• Demonstrates excellent knowledge of ICH guidelines, FDA regulations, and company SOPs related to clinical studies and coaches junior staff
• Contributes to the SOP review process and/or other Clinical Operations Initiatives
• Ensures Trial Master File (TMF) is maintained throughout the study and helps with periodic TMF audits
• Maintains a complete and updated regulatory file for each assigned site
• Practices professionalism and integrity in all actions and relationships with Corcept management, supervisors, team members, and vendors. Demonstrates teamwork, cooperation, self-mastery, and flexibility to get the work done
• Travel may be up to 30% occasionally

Preferred Skills, Qualifications and Technical Proficiencies:

• Technical knowledge and experience managing most aspects of clinical studies
• Experience in the pharmaceutical industry
• Excellent knowledge of US and GCP/ICH regulations
• Understanding of the clinical trials process, the application of SOPs, and medical terminology
• Interpersonal, problem-solving, and organizational skills
• Self-motivated and able to motivate others
• Attention to detail and ability to prioritize tasks to meet critical deadlines
• Ability to read and understand scientific literature
• Excellent verbal and written communication
• Organization and time management
• Ability to develop and deliver compelling and concise presentations
• Able to work effectively on project teams and independently
• Strong proficiency in Microsoft Office and ability to utilize a wide range of computer applications and tools

Preferred Education and Experience:

• BA/BS degree in a relevant field, nursing degree, or equivalent experience
• 4+ years of experience working in clinical research for a Sponsor company, CRA/field monitor, or CRO setting

The pay range that the Company reasonably expects to pay for this headquarters-based position is $149,000-$170,000; 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.

We are seeking a dynamic and strategic professional to join our organization as a Sourcing Manager within Clinical Research & Development. In this role, you will lead the development and execution of sourcing strategies, manage a diverse supplier portfolio, and drive continuous improvement across procurement processes. You will work cross-functionally to enhance supplier performance, manage risk, and deliver cost-effective, high-quality solutions aligned with business goals. This role supports Clinical Research & Development teams by leading sourcing activities and vendor negotiations for Corcept’s clinical trials. This position requires strong analytical skills, excellent communication, strategic thinking, and a proven ability to build and maintain effective supplier and stakeholder relationships.

Key Responsibilities:

• Develop and implement sourcing strategies to achieve procurement goals and long-term business objectives
• Lead the creation and finalization of Site Clinical Trial Agreements (CTAs), CRO agreements, and Investigator Grant budgets
• Develop global contracting strategies, including site-specific timelines and templates to streamline trial start-up
• Manage supplier relationships to ensure high-quality, cost-effective products and services
• Oversee supplier performance through evaluations, KPIs, and continuous improvement initiatives
• Conduct market research and financial analysis to inform sourcing decisions and negotiate contracts
• Optimize supply chain performance and drive cost-saving initiatives across assigned categories
• Identify, assess, and mitigate supply-related risks
• Lead RFP processes and validate suppliers based on business and quality requirements
• Collaborate with internal teams to align strategies and resolve issues
• Investigate supplier-related issues or complaints and ensure corrective actions are completed
• Provide regular reporting and insights to senior leadership on sourcing performance and opportunities
• Contribute to procurement policy development, process improvements, and operational efficiencies
• Ensure adherence to contract terms, regulatory requirements, and company policies
• Stay current on industry trends, supply market intelligence, and best practices

Qualifications:

• Bachelor’s degree in a related field or equivalent work experience
• Minimum of 5 years of experience in sourcing, procurement, or supply chain management within the biotechnology or pharmaceutical clinical environment, with a strong understanding of the drug development process
• Experience in leading and supporting sourcing initiatives (rapid sourcing, targeted negotiations, supplier relationship management, outsourcing), including successfully negotiating economic terms with CROs and vendors
• Strong analytical, financial, and problem-solving skills
• Excellent verbal and written communication abilities; capable of engaging stakeholders at all levels
• Experience managing supplier portfolios and executing sourcing strategies
• Results-oriented, strategic thinker with the ability to lead complex projects
• Ability to work cross-functionally and influence decisions in a matrixed environment
• Experience negotiating contracts and resolving supplier disputes
• Ability to travel up to 10% (if applicable)
• Commitment to fostering diversity, equity, and inclusion within the supply base and workplace

The pay range that the Company reasonably expects to pay for this headquarters-based position is $150,700 – $177,300; 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.

The Manager, Patient Safety & Pharmacovigilance (PSPV) Compliance, Standards, and Training is responsible for supporting and managing activities for the execution and day-to-day oversight of PSPV compliance activities, including metrics/KPIs, maintenance of procedures, training programs, and quality system processes supporting both investigational and marketed products. This role partners closely with PSPV sub-functions, Quality Assurance, Clinical, Regulatory, and external vendors to ensure ongoing regulatory compliance.

Key Responsibilities

• Support operation and maintenance of the PSPV Quality Management System (QMS), ensuring procedures and processes are implemented consistently and in alignment with regulatory requirements
• Author, review, revise, and maintain PSPV procedures, work instructions, and related controlled documents in compliance with global PV regulations (FDA, EMA, ICH)
• Contribute to and manage activities for the development, implementation, and maintenance of role-based PV training programs, including initial and refresher training as well as monitoring of training completion and related compliance metrics/key performance indicators (KPIs)
• Contribute to and manage activities for the development, compilation and reporting of PV compliance metrics and KPI activities, including assessment of performance trends, compliance status, and identification of potential areas for improvement
• Support PSPV inspection readiness activities, including preparation of documentation, participation in mock inspections, and support of regulatory inspections
• Manage deviation, CAPA, and change control activities related to PSPV processes, including investigation support, documentation, and effectiveness checks
• Monitor changes in pharmacovigilance regulations and guidelines and support implementation of required procedural or training updates
• Support activities for the review, update, and ongoing maintenance of the Pharmacovigilance System Master File (PSMF), including coordination of routine reviews and contribution updates across functions and vendors

Required Skills and Qualifications

• Ability to operate effectively in a regulated, fast-paced environment while managing multiple priorities
• Strong working knowledge of pharmacovigilance regulations and guidelines, including FDA, EMA, and ICH requirements
• Experience with Quality Management Systems (e.g., Veeva or similar systems) are a plus
• Strong organizational, documentation, and attention-to-detail skills
• Effective written and verbal communication skills with the ability to collaborate across functions and with external vendors

Education and Experience

• Bachelor's degree in life sciences, healthcare, or a related discipline; advanced degree (e.g., RN, BSN, PharmD) preferred
• Minimum of 5 years of experience in Patient Safety/PV with 2+ years of related experience in PV compliance, standards, training, or quality system activities
• Experienced in managing quality events (deviations, CAPAs, change controls)
• Inspection/audit support experience and project management skills preferred

The pay range that the Company reasonably expects to pay for this headquarters-based position is $160,000 – $200,000; 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.

Lead the preparation of CMC Regulatory documents from pre-IND to marketing authorization submissions in multiple therapeutic areas, molecules, and regions. This position will lead direct reports in the CMC regulatory team, keep up to date on evolving regulations, and lead regulatory intelligence activities. This is a hybrid role that typically requires on-site presence three days per week.

Responsibilities:

• Effectively maintain, and motivate a high-performing regulatory CMC team, including developing, coaching, and mentoring diverse, talented, and driven staff
• Lead regulatory - CMC intelligence activities
• Lead regulatory CMC activities for assigned projects consistent with global regulatory requirements , and company policies and procedures
• Provide Regulatory CMC guidance to internal teams and lead cross-functional teams to plan and prepare briefing packages, and CMC sections for INDs, and equivalent IMPD sections for CTAs, NDAs/MAAs and other global submissions
• Assess the regulatory impact of proposed manufacturing process changes
• Track regulatory CMC commitments; manage ongoing regulatory submissions and future reporting requirements, including annual reports
• Lead interactions with regulatory agencies for assigned programs
• Maintain knowledge of the global regulatory CMC environment and applicable regulations and guidelines, and communicate changes in regulatory information to cross-functional teams

Preferred Skills, Qualifications and Technical Proficiencies:

• Has successfully led responses to health authorities or other critical submissions while maintaining agreed timelines
• Demonstrated leadership and success in management of regulatory activities with a proven track record of effective collaboration with Global regulatory agencies
• Excellent verbal and written communication skills

Preferred Education and Experience:

• Bachelor's or advanced degree in a scientific discipline, with 10+ years of experience working in Regulatory Affairs in the biopharmaceutical industry
• Experienced in building, developing, and managing high functioning teams
• Direct experience with pharmaceutical regulatory submissions and product approvals, managing major regulatory filing(s) such as IND/CTA or NDA/MAA
• Direct experience with regulatory submissions to PMDA is desirable
• Experience with small molecules is preferred
• Experience in successfully leading assigned activities within cross-functional teams

The pay range that the Company reasonably expects to pay for this headquarters-based position is $238,900 – $281,100; 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.

The CS is accountable for implementing the sales strategies for approved products consistent with Corcept’s compliance standards as well as all applicable legal requirements for those key targeted health care providers and hospital systems within an assigned territory.

Responsibilities:

• Build and develop professional relationships with influential high prescribers and thought leaders in the territory to enhance Corcept brand and product loyalty
• Leverages expertise and knowledge of the therapeutic disease state, the marketplace, applicable competitors, industry, and cross-functional activities/plans to anticipate and effectively manage business opportunities and challenges
• Develops and implements effective customer specific territory plans and communicates insights to internal stakeholders
• Prioritizes time and effort to ensure optimal coverage of appropriate physician specialists based on opportunity and potential
• Plan and participate in education programs and speaker dinner programs
• Manage territory expenses/budget to support sales and marketing activities

Preferred Skills, Qualifications, or Technical Proficiencies:

• Proven track record of consistent high performance
• Strong ability to collaborate and work cross-functionally
• Required to travel up to 100% of the time, including up to 40% overnight travel
• Must maintain a driving record in accordance with Corcept vehicle policy
• Able to lift and/or move up to 35 pounds

Requirements:

• BA/BS or equivalent work experience
• 5+ years sales experience required, recent endocrine relationships, specialty therapeutic, hospital, or orphan drugs sales experience highly preferred

The pay range that the Company reasonably expects to pay for this position is $140,000 - $155,000; 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.

The Senior Manager, Privacy Operations will be responsible for implementing, operationalizing, and continuously improving Corcept’s global privacy program. This role will translate legal and regulatory privacy requirements into practical, scalable, and auditable operational processes across the organization.

The role requires close collaboration with IT, HR, Clinical, Commercial, Drug Safety, and Quality functions to ensure that privacy requirements are embedded into day‑to‑day business activities, systems, and vendor relationships. The ideal candidate combines strong privacy program management experience with the ability to work hands‑on in a regulated pharmaceutical environment. The role also offers the opportunity to support broader compliance topics.

This is a hybrid position typically requiring on-site presence 3 days per week.

This role reports to the Sr. Director, Legal & Privacy.

Responsibilities:

Privacy Program Operations

• Implement and maintain the Corcept’s privacy program, including policies, guidelines, and work instructions
• Operationalize privacy requirements under applicable data protection laws (e.g., GDPR, UK GDPR, CCPA, U.S. state privacy laws, and other global regulations)
• Maintain records of processing activities (RoPA), data inventories, and supporting documentation
• Support privacy‑by‑design principles in business processes and systems

Data Subject Rights & Incident Management

• Own and manage the intake, tracking, and fulfillment of data subject rights requests (DSARs), including access, deletion, correction, and objection requests
• Support privacy incident and breach response activities, including intake, triage, investigation support, documentation, and remediation tracking
• Coordinate with internal stakeholders to ensure timely, accurate, and well documented responses within statutory deadlines

Privacy Risk Management

• Coordinate and perform privacy impact assessments / data protection impact assessments (PIAs/DPIAs) in collaboration with IT and business teams
• Identify operational privacy risks and recommend mitigation strategies
• Support internal audits, inspections, and regulatory inquiries related to privacy

Vendor Privacy Support

• Support vendor privacy due diligence and onboarding processes, including privacy questionnaires and risk assessments
• Assist with the operational implementation of data processing agreements and privacy‑related contractual requirements
• Track and monitor privacy obligations applicable to vendors

Training, Awareness & Enablement

• Develop and deliver role‑based privacy training and awareness materials
• Act as a point of contact for business teams on operational privacy questions
• Promote a culture of privacy, accountability, and data protection across the organization

Reporting & Continuous Improvement

• Track and report on privacy metrics and key performance indicators (KPIs)
• Identify opportunities to streamline and automate privacy processes and workflows
• Monitor regulatory developments and recommend operational enhancements as needed

Preferred Skills, Qualifications and Technical Proficiencies:

• Hands‑on experience operationalizing privacy programs in a regulated environment, preferably pharmaceuticals, biotech, or life sciences
• Strong working knowledge of global privacy frameworks, including GDPR, CCPA and U.S. privacy laws
• Demonstrated experience managing DSARs, PIAs/DPIAs, and privacy incident workflows
• Familiarity with Privacy management and workflow tools (e.g., OneTrust or similar platforms), Data mapping, RoPA, and DSAR management tools
• Familiarity with information security and IT concepts (e.g., access controls, encryption, data lifecycle management)
• Proficiency with Microsoft 365 tools (Excel, Word, PowerPoint, Teams) for documentation and reporting
• Ability to translate legal requirements into clear, practical operational processes
• Strong project management, organizational, and documentation skills
• Excellent communication skills with the ability to work effectively across legal, technical, and business teams

Preferred Education and Experience:

• 7+ years of experience in privacy and data protection, preferably in the pharmaceutical/biotech/life sciences industry
• Bachelor’s degree required
• Relevant privacy or compliance certifications preferred, such as:
  • Certified Information Privacy Manager (CIPM)
  • Certified Information Privacy Professional (CIPP/US, CIPP/E, or equivalent)

The pay range that the Company reasonably expects to pay for this headquarters-based position is $193,770 – $227,880; 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.

Responsibilities 

• Prepare and maintain recurring HR reports and dashboards, including headcount, turnover, compensation, and other key people metrics
• Develop ad hoc reports and queries to support business needs across HR and cross-functional partners
• Perform data analysis to identify trends, anomalies, and insights, providing summaries to HR leadership
• Support monthly, quarterly, and annual people metrics reporting cycles
• Maintain and audit HR data for accuracy, completeness, and consistency across systems
• Support data updates related to new hires, terminations, job changes, compensation adjustments, and organizational structure changes
• Support compliance reporting such as EEO, 503, VEVRAA, Pay Transparency, and other regulatory requirements (as applicable)
• Assist in documenting HR reporting processes, SOPs, and data standards
• Help improve HRIS workflows and automation opportunities to drive efficiency and scalability
• Work closely with HR, Finance, Payroll, and other internal teams to deliver data needed for planning cycles and operational processes
• Serve as a knowledgeable resource for HR data-related inquiries, ensuring accuracy, clarity, and confidentiality

Preferred Skills, Qualifications, and Technical Proficiencies 

• Strong attention to detail with a commitment to accuracy and data integrity
• Solid analytical skills - ability to interpret data, identify patterns, and summarize findings
• Intermediate Excel skills, including VLOOKUP/XLOOKUP, pivot tables, and basic formulas
• Experience with HRIS reporting tools preferably Dayforce or an equivalent system such as Workday, UKG, ADP 
• Excellent communication skills with the ability to collaborate effectively across teams
• Ability to manage multiple priorities in a fast-paced and dynamic environment
• Self-motivated, proactive, and able to work independently
• Operates with discretion and maintains strict confidentiality of employee data
• Strong problem-solving and critical thinking skills  

Preferred Education and Experience 

• Bachelor’s degree in Human Resource Management, Industrial-Organizational Psychology, Data Science, Business Analytics, or a related field (or equivalent experience)
• 2–4 years of experience in People Analytics, Business Analytics, Data Science, HR operations, HRIS
• Experience with dashboards, or business intelligence tools (Power BI, Tableau, etc.) is a plus

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.

The Corcept Quality Systems Technology (QST) leader will have primary responsibility for evaluating Veeva Quality software projects and prioritizing the most critical projects for the QA department and Corcept. This role requires a strategic thinker who partners cross-functionally to achieve shared objectives, prioritizes and justifies software projects to meet objectives, and sets clear direction to get there. The leader should be comfortable leading complex system projects, support validation tasks as needed, and directly manage project execution while maintaining strategic oversight. 

The leader should demonstrate the ability to translate business growth and rising complexity into a coherent software strategy, including a 2-year strategic framework that supports sustained growth and organizational maturity. Projects include new implementations, software enhancements, and other continual process improvements. 

The role will support all of Corcept’s quality and GxP operations, leading cross-functional collaboration across teams with diverse and opposing priorities and aligning on the best path forward to achieve high-impact outcomes. Because QST supports all phases of clinical, manufacturing, and development operations, this individual will need to apply sound judgment in developing practical, risk-based, and phase-appropriate solutions.  

This is a hybrid role that typically requires on-site presence three days per week.

Responsibilities: 

• Align QST objectives with departmental and corporate expansion growth goals, ensuring projects deliver measurable business value
• Partner cross-functionally to deliver phase-appropriate solutions that strengthen Corcept’s quality management system and meet business needs 
• Evaluate, prioritize and successfully deliver scalable software solutions that support GxP-compliant operations, ongoing enhancements, and day-to-day operations 
• Exercise sound judgment in balancing GMP and GCP considerations to meet regulatory and operational requirements 
• Balance competing priorities and compliance risks, while maintaining project momentum 
• Serve as Subject Matter Expert (SME) for Veeva Quality in regulatory inspections by proactively identifying compliance risks, implementing corrective actions or mitigations 
• Lead, coach, and develop the Quality Systems team by setting goals, identifying development opportunities, and assisting in individual career development and growth 
• Partner with teams to manage vendor relationships, agreements, and user licenses to scale with Corcept’s expanding footprint and evolving software needs 

Required Skills, Qualifications, and Technical Proficiencies: 

• Demonstrated ability to navigate ambiguity and set direction 
• Proven leadership skills in a cross-functional role 
• Guide and develop team members 
• Excellent problem-solving and meeting facilitation skills 
• Excellent written and oral communication skills 
• Working knowledge of Veeva Quality, LMS systems 
• Ability to influence others at various levels of the organization 
• Previous hands-on configuration experience is a plus  
• Direct involvement and experience with regulatory inspections and audits 
• Vendor evaluation and selection process 
• Working knowledge of principles for software validation, CSA, GAMP5 
• Experienced and well-versed in System Development Lifecycle (SDLC) 

Preferred Education and Experience: 

• BA/BS in a scientific discipline 
• 10+ years’ experience in pharmaceutical QA 
• Strong knowledge of GCP and GMP requirements, including ICH E6, ICH Q9-Q10, 21 CFR 210/211, and specific regulatory authority requirements (FDA, EMA, PMDA, etc.) 
• Experience working with enterprise systems, integrations, and phase-appropriate QMS implementation 
• Experience with managing budgets 

The pay range that the Company reasonably expects to pay for this headquarters-based position is $192,700 – $226,700; 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.

The Clinical Trial Manager (CTM) will independently manage all clinical aspects of a medium to large clinical study or up to two smaller clinical studies.  This role will work closely with cross-functional teams, vendors, sites, and CRO (when applicable) to ensure compliance with protocol and the overall clinical objective. Additionally, this role will be responsible for implementing and monitoring clinical study activities to assure adherence to good clinical practices (GCPs), standard operating procedures (SOPs), and study protocols. This is a hybrid role that typically requires on-site presence three days per week.

Responsibilities: 

• Responsible for the implementation and quality execution of assigned clinical protocols according to Corcept SOPs, ICH/GCP, and corporate and department program goals
• May serve as a Study Lead to the multifunctional team to ensure clinical study/studies activities, including study start-up, enrollment, maintenance, and closeout, are executed per timelines and budget.
• Oversees aspects of study management and vendors to ensure high quality of data
• Providing Clinical Research Associates with project-specific training, guidance, and oversight, assigning deliverables and having regular meetings with them
• Develops clinical trial protocol synopsis, protocols, amendments as directed by the Clinical Development team and while working with Medical Writing
• Develops critical study documents such as informed consent form templates, site management, and monitoring tools
• Evaluates study designs from an operations perspective, and considers site implementation tactics to suggest feasible solutions and contribute to overall program design and execution
• Develops study timelines and budgets per the corporate and departmental goals and continuously strives to ensure timelines and deliverables are met within budget
• Responsible for tracking and managing study execution to resources and goals
• Facilitating the CRO/Vendor selection process for outsourced activities, including developing an RFP, managing the bidding process, analysis of proposals, budgets, and leading and documenting vendor selection decisions.  Includes review of Scope of Work, budgets, and negotiating contracts through execution
• Escalates concerns regarding timelines, milestones, resourcing, and any potential study execution issue to appropriate internal stakeholders
• Creates a process for developing distribution, reviews, and tracking essential trial documents and/or oversees CRO or CRA responsibility for essential documents
• Collaborates with team CRAs to ensure essential trial documents are provided to Regulatory for submission to the FDA and other regulatory agencies for IND Updates and Amendments
• Develops and ensures compliance with clinical monitoring plan; conducts or oversees co-monitor as needed for staff training and quality assurance (QA) purposes
• May conduct and/or attend PSVs, SIVs, IMVs, and COVs
• Partners in the development of the case report form (CRF) design process including content, form layout, and edit check review
• Liaison with chemistry, manufacturing, and controls (CMC) team to forecast and monitor overall drug supply and expiration to ensure adequate availability throughout the trial
• Ensures CRA(s) maintain a complete and updated regulatory file for each assigned site
• Manages oversight of Investigational Product (IP) accountability and ensures adequate site supply
• Manages safety reporting to sites and regulatory agencies
• Procures and manages contracts with CROs, study vendors, and investigative sites
• Manages and/or provides oversight of CROs, independent field monitors, and other clinical vendors
• Ensures monitoring trip reports are reviewed and track resolution of all action items on time, per the Monitoring Plan or Corcept SOPs
• Co-monitors at investigative sites to evaluate study site and field monitor performance
• Manages, either directly or through supervised delegation, other study-wide activities such as external vendors, sample handling, drug re-supply, investigator payments, overall data quality, and overall central records quality
• Serves as in-house contact for protocol-related process questions and tracks questions/processes for best practices and consistency
• May help audits clinical data reports for accuracy, safety, and/or efficacy trends; as necessary prepare related presentations
• Exercises sound judgment to resolve or, as appropriate seek expert input on protocol and drug questions, safety, regulatory, and legal questions. Ensures resolution is tracked and consistently messaged to all team members and clinical sites
• Contribute to the SOP review process and other Clinical Operations Initiatives, as necessary
• Demonstrates excellent knowledge of ICH guidelines, FDA regulations, and company SOPs related to clinical studies and coach junior staff on the same
• Ensures Trial Master File is maintained throughout the study
• Practices professionalism and integrity in all actions and relationships with Corcept management, supervisors, team members, direct reports, and vendors. Exhibits and models leadership behavior through communication and appropriate temperament. Ability to have difficult/crucial conversations with tact. Demonstrates ability to foster teamwork, cooperation, self-mastery, and flexibility to get the work done.  Maintains composure under difficult circumstances
• Travel may be up to 30% occasionally
• This position may supervise the following positions: Clinical Operations Consultants and Clinical Research Associates

Preferred Education and Experience: 

• Relevant BS / BA degree or nursing degree
• 6+ years’ experience as a CRA or field monitor in a biotech, pharmaceutical, or CRO company
• Study-related management experience

Preferred Skills, Qualifications, or Technical Proficiencies: 

• Attention to detail and ability to prioritize tasks to meet critical deadlines
• Excellent verbal and written communication
• Able to collaborate effectively with the study team, cross-functional team members, and external partners
• Knowledge of US and GCP/ICH regulations
• Understanding of the clinical trials process, the application of SOPs, and medical terminology
• Strong interpersonal, problem-solving, and organizational skills
• Self-motivated and able to motivate others
• Sound judgment and discretion
• Attention to detail and ability to prioritize tasks to meet critical deadlines
• Ability to read and understand scientific literature
• Strong organization and time management skills
• Ability to develop and deliver compelling and concise presentations
• Able to work effectively on project teams and independently
• Strong proficiency in Microsoft Office and ability to utilize a wide range of computer applications and tools

The pay range that the Company reasonably expects to pay for this headquarters-based position is $156,600-$184,300; 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.

The Senior Clinical Trial Manager (Sr. CTM) will play a key role in shaping and scaling Corcept’s clinical operations processes and SOP framework. This position may also independently manage operational aspects of clinical study. This leader will work with cross-functional teams as well as vendors, clinical sites, and CROs to execute protocol requirements to ensure study deliverables, milestones, and objectives are met within timelines and budget. This is a hybrid role that typically requires on-site presence three days per week.

Responsibilities:

• Proactively identify gaps in workflows and documentation, and designing scalable, inspection-ready SOPs and processes that enable high-quality study execution
• Author updates, and continuously improve SOPs, work instructions, templates, and forms to ensure they are lean, practical, and aligned with ICH-GCP E6 (R2/R3) standards
• Evaluate the downstream impact of SOP and process changes on ongoing trials, vendor contracts, and clinical systems (e.g., CTMS), ensuring seamless adoption without disrupting active programs
• Facilitate cross-functional SOP review and working groups
• Contribute to SOP governance, inspection readiness, and continuous improvement initiatives that strengthen Corcept’s clinical operations infrastructure
• Execute assigned clinical protocol with high quality according to Corcept SOPs, ICH/GCP, and corporate and departmental program goals
• Serve as a study lead to the multifunctional team to ensure clinical study/studies activities including study start-up, enrollment, maintenance, and close-out are executed per timeline and budget
• Work with Clinical Development and/or Medical Writing to generate clinical trial protocol synopsis, protocols, and protocol amendments
• Facilitate the CRO/Vendor selection process for outsourced activities, including developing an RFP, managing the bidding process, analysis of proposals, budgets, and leading and documenting vendor selection decisions. This includes review of cope of ork, budgets, and negotiating contracts through execution
• Procure and manage contracts with CROs, study vendors, and investigative sites
• Develop critical study documents, including informed consent form templates, various management plans, and study trackers
• Develop study timelines and budgets per the corporate and departmental goals and continuously strive to ensure timelines are deliverables are met within budget
• Develop, distribute, review, and track essential trial documents and/or oversee CRO responsibility for essential documents
• Provide Regulatory with Site Essential Regulatory Documents for submission to the FDA and other regulatory agencies
• Manage or provide oversight of CROs, independent field monitors, and other clinical vendors
• Ensure monitoring trip reports are reviewed and track resolution of all action items and protocol deviations
• Manage, either directly or through supervised delegation, other study-wide activities such as external vendors, sample handling, drug re-supply, investigator payments, data quality, and central records quality
• Audit clinical data reports for accuracy, safety, and/or efficacy trends and prepare related presentations
• Ensure the Trial Master File is maintained throughout the study in accordance with regulatory and company requirements

Preferred Education and Experience:

• Relevant BS / BA degree or nursing degree
• 8+ years' experience in a biotech or pharmaceutical company, leading cross-functional clinical activities
• Management experience including outsourcing to Contract Research Organization (CRO)

Preferred Skills, Qualifications, or Technical Proficiencies:

• Knowledge of US and GCP/ICH regulations
• Understanding of the clinical trials process, the application of SOPs, and medical terminology
• Ability to read and understand scientific literature
• Strong proficiency in Microsoft Office and ability to utilize a wide range of computer applications and tools

The pay range that the Company reasonably expects to pay for this headquarters-based position is $170,500-$200,700; 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.

Reporting to the VP, Intellectual Property, the Senior Director, Intellectual Property supports a broad scope of companywide intellectual property matters.  This attorney will be a trusted advisor to the Company by providing strategic counsel on all facets of patent law with a focus on the Company’s small molecule portfolio.  This attorney will also have responsibilities that include trademarks, copyrights, IP litigation and documents.  

The Sr. Director will be onsite in Redwood City, CA, typically 3 days per week.

Responsibilities:

• In this role, you will establish rapport and positive working relationships with project/program teams by acting as their advisor on a variety of IP-related issues including publication reviews, IP agreement negotiation and support, and other IP issues that arise in the usual course of a growing commercial pharma business
• You will advise on a wide range of IP matters, including patent preparation and prosecution, portfolio management of wholly owned and in-licensed IP, IP strategy, IP litigation, patentability and freedom-to-operate analyses
• Prepare and prosecute patent applications, including building relationships within the company to identify inventions and provide guidance to management around IP filing and prosecution strategy to align with the Company’s business objectives
• Work closely with and manage outside IP counsel
• Contributing to the development of consistent policies/procedures for IP disclosure and documentation
• Identify training needs within the organization and assist in the development and presentation of training materials on relevant IP laws and related business issues

Preferred Skills, Qualifications or Technical Proficiencies:

• Active membership in good standing in at least one US state bar is required, as well as be admitted to practice before the U.S. Patent and Trademark Office
• Complex document drafting and negotiations skills required
• Excellent written and verbal communication skills necessary
• Ability to provide timely, practical, and actionable legal advice
• High emotional intelligence, capable of collaboratively influencing decision-making through the respectful exchange of competing ideas and perspectives
• Self-driven to identify and solve complex and challenging problems

Preferred Education and Experience:

• 12+ years of law firm and/or in-house experience handling patent preparation and prosecution with focused expertise on pharmaceutical small molecule matters. A Masters or Ph.D. in Chemistry, Organic Chemistry, or a related chemical science is preferred
• J.D. from a respected US law school and overall strong academic and job history credentials

The pay range that the Company reasonably expects to pay for this headquarters-based position is $265,200 – $312,000; 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.

Responsibilities:

• Design and implement Phase I to III clinical studies
• Develop and participate in the writing and review of protocols, investigator brochures, study reports and other clinical and regulatory documents
• Provide scientific oversight for Company operational staff, CROs, and clinical trial sites in all areas related to the therapeutic programs
• Act as a clinical subject matter expert for both Company team members and for external contacts related to the assigned therapeutic programs
• Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems and final reports
• Act to provide medical oversight and safety monitoring for ongoing clinical trials including participation in SAE reporting and serving on the safety committee
• Play a key role in the analysis, interpretation and delivery of high-quality clinical data
• Interact with principal investigators and opinion leaders to facilitate clinical trials research
• Participate in appropriate regulatory discussion and activities, including the filing of IND’s, CTXs, NDA/MAAs, throughout the development cycle
• Provide training and ongoing input to all members of the clinical team on medical and scientific issues related to the therapeutic field in question
• Participate in clinical study report conceptualization, development and writing for global regulatory submissions
• Work closely and collaboratively with other functions, e.g. clinical operations, safety, biometrics, regulatory, medical writing, medical affairs and commercial
• Develop and give internal and external presentations as subject matter expert for the therapeutic area
• Participate in the development and review of publications
• Participate in the management of human resources in a matrixed environment – recruitment, performance management, succession planning, talent management, etc.

Preferred Skills, Qualifications and Technical Proficiencies:

• Demonstrate strong clinical and scientific knowledge
• Is an excellent communicator with proven leadership skills and the ability to interact in a cross functional environment
• Feel comfortable in a fast-paced and nimble small company environment and able to adjust workload based upon changing priorities

Preferred Education and Experience:

• MD, board-certified (or eligible)
• Expertise in Oncology
• A strong track record of scientific activity, demonstrated by publications in top tier journals
• At least 6+ years of relevant clinical development experience
• Relevant basic and/or clinical research experience in academic settings is viewed favorably

The pay range that the Company reasonably expects to pay for this headquarters-based position is $298,000-$350,600; 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.

As the Senior Manager, SG&A Accounting, you will help lead SG&A accounting operations, and be the  as strategic business partner for over 40 departments. This position will report to the Director of Accounting and will manage/mentor accounting analysts.  You will have the opportunity to lead projects that shape the Finance organization and Corcept, overall, as we continue to grow.

Responsibilities:

• Full ownership of managing the financial close for SG&A related activities in accordance with GAAP to ensure the accuracy and integrity of financial data
• Lead day-to-day SG&A accounting operations, including general ledger management, journal entry preparation and review, account reconciliation and close support
• Support accounting coverage for more than 40 departments, serving as a reliable finance partner to business stakeholders
• Drive end-to-end coordination of projects and system/process improvements to keep the accounting team current, scalable, and able to support a growing SG&A organization
• Manage and mentor one or more accountants, cultivating talent, delegating ownership, and showcasing the team's achievements to stakeholders
• Review, interpret, and apply consistent accounting treatment for a wide range of contracts, including:
  • Consulting and professional services
  • Subscriptions and SaaS tools
  • Milestone-based agreements
  • Medical grants and sponsorships
  • Conference and marketing agreements
  • Analytical and research services
• Build and sustain trusted partnerships with SG&A leaders, serving as the primary accounting advisor for operational and financial decision-making
• Assess proper accounting treatment (expense vs. prepaid vs. capitalization) with clear rationale and documentation
• Review invoices to ensure expenses are accurately recorded into the accounting system
• Help prepare quarterly reviews and year-end audits and periodic reports to the SEC
• Continually drive process improvements for greater efficiency and timeliness

Preferred Skills, Qualifications and Technical Proficiencies:

• Maintain a strong sense of work accountability and is a self-starter
• Strong project management capabilities, with a track record of successfully leading and executing complex initiatives; Able to effectively manage and prioritize multiple tasks, and work with tight deadlines
• Exceptional critical thinking and problem-solving abilities, enabling effective solutions for complex challenges
• Adept at identifying process inefficiencies, creating practical solutions, and driving continuous improvements

Preferred Education and Experience:

• Requires a Bachelor’s Degree in Accounting or Finance
• At least 8 years of relevant work experience in accounting management
• Experience in biotech/pharmaceutical environment is preferred
• CPA with Big 4 experience is a strong plus
• Knowledge of/exposure to Netsuite accounting system is a strong plus

The pay range that the Company reasonably expects to pay for this headquarters-based position is $162,810 – $191,520; 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.

This will serve as the PSPV lead for cross-functional activities and commercial initiatives, ensuring successful product launch and lifecycle management with patient safety integrated throughout the organization. This highly visible role will act as a strategic partner to Medical Affairs, Quality, Legal, and Commercial teams, driving operational and compliance excellence across all touchpoints. This is a hybrid role typically requiring on-site presence at least 3 days per week at company headquarters in Redwood City.

Responsibilities:

Cross-Functional Leadership & Collaboration:

• Build strategic partnerships and alignment of patient safety objectives and deliverables with internal stakeholders (Medical Affairs, Quality, Legal, Commercial) and external vendors/partners
• Establish and lead cross functional governance forum with PSPV, Medical Affairs, Quality, Legal, Commercial to review all commercial initiatives/activities for cross functional planning and execution
• Act as the Safety Lead for implementation and oversight of call center and commercial programs (e.g., specialty pharmacies, patient support programs, market research, distributors, etc.) including:
  • Reviewing vendor agreements and program materials to ensure inclusion of safety-related reporting requirements and deliverables
  • Ensuring appropriate systems and processes are in place for reporting safety information to Corcept in compliance with binding obligations and global reporting timelines
  • Developing and coordinating adverse event reporting training
  • Overseeing reconciliation processes between vendors and internal PV systems to ensure completeness and accuracy of safety data
  • Ensuring appropriate quality controls are in place for the call center and commercial programs, including source data verification and quality sampling of safety data
  • Maintaining tracking of vendors/providers for the pharmacovigilance system master file
  • Collaborate closely with Medical Affairs to integrate key safety messages into scientific communications and materials

Compliance & Quality Oversight:

• Contribute to review of deviations and CAPAs for commercial programs and call center
• Monitor and report compliance key performance indicators for commercial programs and call center to PSPV compliance lead
• Support audit and inspection readiness, including being the PSPV SME for commercial programs and call center activities

Strategic Planning & Process Optimization:

• Identify opportunities for process improvements and technology solutions to enhance PV systems and workflows
• Stay current with evolving global PV regulations and assess impact on organizational practices
• Support development of PV strategies aligned with corporate objectives and patient safety goals

Preferred Skills, Qualifications and Technical Proficiencies:

• Ability to work in a dynamic environment to meet patient and corporate needs
• Deep knowledge of global PV regulations (ICH, GVP, FDA, EMA)
• Proven ability to lead cross-functional teams and influence commercial strategies
• Ability to manage multiple projects in a fast-paced environment
• Excellent communication (written and verbal) and stakeholder management skills
• Proficiency in safety database systems (e.g., Argus) and electronic reporting requirements
• Able to travel for up to 10% of time

Preferred Education and Experience:

• Degree in Healthcare or Life Sciences; advanced degree preferred
• 10+ years in pharmacovigilance biopharma
• 5+ years in leadership roles with cross-functional and commercial exposure
• Experience with vendor management and regulatory inspections

The pay range that the Company reasonably expects to pay for this headquarters-based position is $240,000- $280,000; 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.

We are seeking an Associate Director to lead Corcept’s Document Control Program, an essential element of our Quality Management System (QMS). This leadership role requires a proven track record of advancing document control by remediating critical gaps, and implementing sustainable, risk-based controls that achieve GxP requirements. This role owns the strategy, execution, and compliance of the program and its supporting software.

This leader champions a culture of SOP engagement, and accountability across departments, ensuring that stakeholders adhere to Corcept’s SOP standards. This involves communicating and coordinating SOP revisions involving everything from simple changes to complex system overhauls under compressed timeliness.

This role requires a strong, focused leader who delivers high-visibility changes, drives implementation with resilience and clarity, and resolves obstacles and dynamic priorities. The leader communicates a clear and compelling vision, and guides teams through change using collaborative "come with me" leadership.

The role requires pharmaceutical or biotechnology experience involving single product to multi-product transformation including the design of scalable business processes, modification of computer systems, and updating metadata.

This is a hybrid role typically requiring on-site presence at least 3 days per week.

Responsibilities:

• Lead and mentor a committed team of Document Control professionals, aligning through shared purpose, empowerment, and transparency. Foster a culture of ownership, agility, quality excellence, and professional growth
• Strengthen the Document Control Program and supporting software by remediating compliance risks, and architecting processes, metadata, and complex computer system configurations including security
• Evaluate and implement solutions to support a scalable, multi-product environment in compressed timelines resulting in a robust, inspection-ready program that achieves GxP standards
• Partner closely with Training program lead to integrate document process changes and system configuration changes to proactively address organizational change management of impacted personnel
• Assume software Business System Owner responsibilities, ensuring data and metadata maintenance and periodic system review
• Drive and manage high-volume SOP authorship, revision, and implementation — often under accelerated timelines
• Lead technical sessions as needed that elicit system requirements to scale Veeva QDS (QualityDocs) capabilities and ensure projects line up with Quality Systems project portfolio
• Establish and track key performance indicators (KPIs) to monitor and ensure system effectiveness, inspection readiness, and accountability

Preferred Skills, Qualifications and Technical Proficiencies:

• Demonstrated success in leading organizational change management initiatives, including system and procedural overhauls
• Support compliance remediations by ensuring high volume of SOP changes are completed within abbreviated timelines
• Build effective partnerships across GxP departments including QA, Regulatory, IT, Manufacturing, and Development to build solutions
• Technical expertise as business owner of Veeva QDS with demonstrated success in transforming systems, associated business processes, and configuration from a single product to a multi-product and multi-geographical site system
• Clear and concise written communication skills to align documentation to Corcept’s Quality Policy/Manual, using established Document Control tools to deliver consistent, quality written work
• Inspirational leadership style with a proven ability to guide teams through complexity and ambiguity
• Experienced in presenting to executive leadership and acting as a visible leader during audits and inspections
• Excellent verbal and written communication skills with the ability to influence a wide range of stakeholders in various departments
• Strong working knowledge of pharmaceutical GxP standards and their impact on SOPs, work instructions, and controlled documents
• Designed applicable document control processes that integrate with GxP Training program
• Extensive experience as Business System Owner of Veeva QDS

Preferred Education and Experience:

• BA/BS degree in a scientific/technical/engineering field
• 10+ years of experience in pharmaceutical or life sciences industry
• Veeva certification

The pay range that the Company reasonably expects to pay for this headquarters-based position is $186,500 - $219,400; 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.

The Senior Manager, Compliance Operations will provide support for the enterprise-wide compliance program. This position will play a key role in ensuring Corcept adheres to legal and regulatory standards by managing audits, monitoring processes, supporting investigations, and ensuring compliance with internal policies and procedures. This includes updating policies and procedures, providing training, collaborating with other departments, generating reports, and evaluating program needs to ensure that operations are appropriate to meet the program’s objective and long-range goals. 

This is a hybrid position typically requiring on-site presence 3 days per week. 

This role reports to the Sr. Director of Legal who is responsible for Corcept’s Compliance Program.

Responsibilities:

• Documentation and reporting: Oversee the updates to and maintenance of Corcept’s policies, procedures, work instructions, training materials, and other compliance-related documents. Develop a framework for evaluating how compliance documents are assessed for fitness and accuracy and when updates are required. Compile and analyze compliance data for internal reporting
• Training and education: Develop, implement, and deliver compliance training programs for employees that align with program and organizational goals. Develop and maintain appropriate tools to track and report employee training completion metrics
• Investigations and corrective actions: Support investigations into potential compliance violations, help implement corrective and preventive actions (CAPA), and ensure proper documentation
• Audits and monitoring: Oversee internal and external audits, monitor processes for adherence to internal policies and procedures, and regulatory standards, and help analyze data to identify risks or areas for improvement
• Cross-functional collaboration: Work with Quality Assurance, Human Resources, and other departments to ensure consistent compliance practices across the organization
• Risk management: Conduct compliance program risk assessments and develop strategies to mitigate risks
• Operational Support: Assist the Compliance Program Lead with outreach and materials preparation for Corporate Governance Committee, Compliance Committee, and compliance working group meetings. Maintain the master compliance document repository and the various software tools used by the Compliance team (SharePoint, MedCompli, compliance hotline, etc.)

Preferred Skills, Qualifications and Technical Proficiencies:

• Understanding of the laws and regulations impacting pharmaceutical compliance (False Claims Act, Anti-Kickback Statute, HIPAA, the Stark Law, etc.)
• Working knowledge of the elements of an effective compliance program, the PhRMA code, and the role of compliance in prevention and oversight
• Proven ability to develop and maintain comprehensive and impeccably organized documentation including policies, procedures, and evidence collection
• Strong communication skills—able to establish credibility and convey complex compliance matters clearly to diverse audiences
• Adept at learning new technical areas
• Experience with using and maintaining SharePoint sites, MedCompli and MediSpend, or other compliance software tools will be given consideration
• Self-driven to identify and solve complex and challenging problems
• Ability to understand business needs and exercise sound judgment on key decisions, including the ability to make independent decisions and recognize circumstances that require escalation
• Comfortable managing and prioritizing competing priorities and frequent interruptions while maintaining close attention to detail, accuracy and timeliness
• A mindset for continuous improvement and a willingness to educate the business about compliance

Preferred Education and Experience:

• Bachelor’s degree preferred. CHC/CPCO/CCEP/CCP Certification a plus
• 7-9+ years of experience in a compliance operations role (preferably in the pharmaceutical/life sciences industry), with a track record of building and managing compliance programs
• If you possess strong compliance acumen, leadership skills, and the ability to influence outcomes while maintaining impeccable ethics, apply today!

The pay range that the Company reasonably expects to pay for this headquarters-based position is $193,770 – $227,880; 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.