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Karyopharm Therapeutics Inc. (the "Company") is an equal opportunity employer. All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law. Consistent with its obligations under applicable law, the Company will make reasonable accommodations for qualified individuals with disabilities. If you require an accommodation in the application process, please contact a member of the Company’s Human Resources department.
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The Medical Director, Pharmacovigilance (PV) will provide broad support of activities requiring medical safety input for assigned products, pre- and post-approval. He/she will support and/or lead periodic safety signaling reviews and meetings, as well as perform individual and aggregate case review. He/she will also participate, in varying degrees, on clinical teams/programs and other intra and/or inter-departmental activities and initiatives.
Reporting to our Vice President Pharmacovigilance, you will positively impact patients’ when you:
- Represent department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues.
- Provide timely and sound medical review of individual case safety reports from clinical trials or post-marketing sources as needed.
- Participate in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans.
- Participate in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports.
- Contribute to preparation and review of periodic reports (IND, Annual Safety, DSUR, PSURs, CSR).
- Review and provide medical content, as needed, for key study-related documents, e.g. IB, ICF, IDMC Charter.
- Participate in departmental development activities including SOP and Work Instructions development.
- Provide guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective.
- Provide a contributory role in Partner /Affiliate agreements and interactions, as needed.
- As directed by the PV Head, assume primary responsibility/chair for the conduct of one or more Safety Team(s) for assigned products.
- Participate in the regular review of safety data for assigned products for the identification of new safety signals, in accordance with signal detection practices.
- Participate in Risk Management Strategy.
- Other activities, as needed or as requested by manager.
Reporting to our Chief Development Officer, you will positively impact patients’ lives by:
Leading all aspects of the development of an assigned program to approval and market entry. In doing so, the Program Lead will provide high level oversight, management, and drive across the span of product development from strategy formulation to execution of that strategy; this encompasses the entire process from preclinical research through registration and market entry.
- Accountable for leading the cross-functional product strategy team to develop the strategy for the product in the target therapeutic area(s), gain approval for that strategy with KPTI leadership and drive the efficient execution of the approved strategy, on time and on budget.
- Responsible for integrating the input from various disciplines to create, maintain, and execute product development plans that will result in efficient development of pipeline compounds with a differentiated Target Product Profile as well as any clinical studies and other cross-functional deliverables required for regulatory approval and market access of the assigned compound in multiple regions
- Understands the role and contributions of each function to the success of the product development and commercialization and ensures timely and appropriate cross-functional contributions to product strategy development and execution.
- Coordinates between all internal/external stakeholders (e.g. Clin Ops, Medical, Pre-clinical, MSLs, Regulatory, Research, Drug supply, Market Access, Commercial, HEOR, Medical Affairs, Publications, Corporate Communications, Investor Relations, Launch Excellence, Alliance Partners as well as Investigators, Patient groups) to ensure alignment, operational efficiency and program success.
- Provides clear direction in a collaborative manner on product development requirements to meet expectations of internal and external customers, patients and business stakeholders.
- Responsible to proactively monitor the external landscape and emerging data and recommending adjustments to the approved product strategy, or lifecycle management additions to the strategy as appropriate to ensure the maximal value of the product development plan to Karyopharm and to patients from both a development and commercialization perspective
- Responsible for partnering with functional leadership for the high performance of the cross-functional team including coaching team members, or partnering with functional leadership as appropriate
- Responsible for driving project performance, risk management, administration, financial management and issue resolution for the cross-functional team.
- Ensures quality and compliance of the program team in line with company expectations
- May contribute to the identification and evaluation of potential business development opportunities, conduct due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities
- Assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future product development strategic plans interacting with upper management of potential partner/acquisition companies during Due Diligence and alliance negotiations
The Hematology-Oncology Specialist maintains strong professional relationships in the patient care continuum and represents the integrity of Karyopharm Therapeutics by providing approved disease and product information and resources to key decision makers and stakeholders within the oncology community practice setting.
Reporting the Regional Business Director, you will positively impact patients’ when you:
- Develop business plans, market analysis, and strategy that link to strong business results and execute accordingly
- Position on-label benefits for appropriate patients to key customer stakeholders to achieve or exceed forecasted sales goals
- Resolve issues at account level to ensure access to therapy
- Coordinate with colleagues in cross-functional areas including Market Access, Clinical Education, and Medical Affairs to facilitate customer and patient access to Karyopharm product(s) and information
- Provide customer feedback to internal stakeholders, sharing best practices, unmet needs, and business opportunities
- Assist Marketing function in identifying and inviting appropriate healthcare professionals (HCPs) to promotional and educational events or programs
- Develop and maintain mastery of clinical and technical knowledge related to product(s) promoted, the oncology marketplace, and disease management
- Foster and develop relationships with Key Opinion Leaders (KOLs), decision makers, influencers, and key stakeholders within the oncology community
- Deliver clinical and technical value at medical meetings by staffing promotional booths, as requested
- Comply with all laws and regulations and adhere to company compliance guidelines, policy and procedures
- Acts with a sense of urgency on behalf of patients and customer
The Hematology-Oncology Specialist maintains strong professional relationships in the patient care continuum and represents the integrity of Karyopharm Therapeutics by providing approved disease and product information and resources to key decision makers and stakeholders within the oncology community practice setting.
Reporting the Regional Business Director, you will positively impact patients’ when you:
- Develop business plans, market analysis, and strategy that link to strong business results and execute accordingly
- Position on-label benefits for appropriate patients to key customer stakeholders to achieve or exceed forecasted sales goals
- Resolve issues at account level to ensure access to therapy
- Coordinate with colleagues in cross-functional areas including Market Access, Clinical Education, and Medical Affairs to facilitate customer and patient access to Karyopharm product(s) and information
- Provide customer feedback to internal stakeholders, sharing best practices, unmet needs, and business opportunities
- Assist Marketing function in identifying and inviting appropriate healthcare professionals (HCPs) to promotional and educational events or programs
- Develop and maintain mastery of clinical and technical knowledge related to product(s) promoted, the oncology marketplace, and disease management
- Foster and develop relationships with Key Opinion Leaders (KOLs), decision makers, influencers, and key stakeholders within the oncology community
- Deliver clinical and technical value at medical meetings by staffing promotional booths, as requested
- Comply with all laws and regulations and adhere to company compliance guidelines, policy and procedures
- Acts with a sense of urgency on behalf of patients and customer
The Clinical Operations Lead is responsible for oversight of one or more Clinical Programs and associated studies within the program. This includes being a member of the Program Team contributing to strategy and operational expertise (planning, implementation, execution and management of both clinical programs and individual studies). Leading the Clinical Program and oversight of internal clinical staff and CROs to ensure studies are executed in accordance with SOPs, timelines and budget.
Reporting to our Executive Director, Clinical Operations Lead, you will positively impact patients’ when you:
- Represent Development Operations on the Program Team (contribute to drug development strategy, planning, timing, cost projections) at the program level as well as the individual clinical study level
- Deliver data-driven, actionable operational and strategic insights for execution of a clinical development program and all associated studies
- Strategically develop the clinical strategy and plan for execution of clinical studies/programs (i.e. generation of operational timelines, enrollment models, assessment of availability of the patient population, complexity of trial designs etc.)
- Provide the operational perspective to the Clinical Development Plan and to trial protocol design, ensuring that leadership is aware of operational considerations and options
- Drive execution of clinical studies in assigned programs on time and on-budget and for proactive issue management and resolution
- Develop the cross functional study/program costs for the Program Team, portfolio process, and financial updates
- Interact with and influence all levels of management and cross-functional team members to develop strategies and execute plans to achieve program objectives.
- Executie clinical programs in compliance with quality standards (ICH/GCP, Global Regulations, and KPTI policies and all applicable procedures)
- Maintain Clinical Operations business standards across studies (tracking, reporting, agendas/minutes, etc.)
- Maintain a state of inspection readiness, and act as an expert during regulatory inspections
- Perform operational decision making, risk mitigation, and contingency planning as well as operational efficiency and innovation at the program level
- Review and provide clinical operations content to clinical and regulatory documents (IND, IB, NDA, MAA, Regulatory Briefing Books etc.)
- Review and provide expert clinical operations input to and ensure consistency of clinical documents within program and across as needed (study protocols, clinical study reports, study plans, etc.)
- Lead cross-functional and within function innovation and process improvement initiatives and ensures effective change management within the organization
- Develop & Mentor clinical operations staff and create an inclusive and innovative environment where staff and studies/programs will succeed