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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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Karyopharm Therapeutics is a clinical-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.
Reporting to the Senior Director of Clinical Operations, you will positively impact patients’ when you:
- Leads global clinical trials and may be responsible for multiple trials simultaneously.
- Represents and leads the study team to design, develop, execute, and deliver the clinical study in accordance with the clinical development plan/strategy, timelines, budget, and applicable regulations and guidelines.
- Authors/ reviews/ contributes to clinical study documents.
- Reviews and approves study related plans generated by Clinical CROs and vendors.
- Accountable for the timely clinical review and/or approval of Case Report Forms, User Acceptance Testing (UAT), and provides clinical input into corresponding completion guidelines.
- Responsible for proactive planning and successful execution to plan for study (ies)
- Responsible for oversight of identification and selection of investigator sites.
- Responsible for planning and conducting investigator’s meetings in cooperation with the respective departments.
- Responsible for content, accuracy, and maintenance of study files (TMF, etc.) and ensuring the inspection readiness of the trial.
- Serves as the subject matter expert for the study during regulatory inspections.
- Ensures accuracy and information provided in clinical registration websites e.g., www.clinicaltrials.gov.
- Manages escalation of study related issues and communicates cross functionally with the Core and Program Team for alignment on mitigation tactics as well as messaging to Leadership.
- Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight.
- Monitors progress of clinical activity and produces regular and ad hoc reports and presentations as required (including budget, deliverables, and timeline metrics).
- Collaborates with the cross functional teams on clinical activities (drug supply, resolution of data queries, etc.) and on selection and management of clinical vendors.
- Evaluates CRO and vendor performance for future work.
- Reviews budgets and contracts with CROs, vendors, and investigative sites, as applicable.
- Leads team through vendor selection process and may provide input into contracts, change orders, and/or work orders.
- May attend relevant symposia, conferences, and scientific meetings, as necessary.Management of training needs across assigned studies.
- Up to 20% domestic and/or international travel may be required.
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.
As a Karyopharmer, reporting to 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 customers
The Workplace Services Coordinator role is at the forefront of delivering a positive, best-in-class office experience as a company ambassador, community advocate and service leader. As part of a "front-of-house" team, you will be responsible forprovidingtop level service and creating a comfortable atmosphere by greeting visitors and supporting all employee-facing services
This is a fully onsite, part time role with working hours of 8am – 1pm Monday – Friday.
- Greet, welcome and direct allKaryopharm visitors, employeesand incoming phone callsat our world headquarters in Newton, MA.
- Provide day-to-day office operations support (i.e., oversight of office hoteling processes, conference rooms, lobby, stock rooms and kitchen areas)
- Order, set up and clean daily catered lunches for all employees
- Provide daily distribution of mail, incoming & outgoing packages; track all deliveries with Envoy app
- Prepare FedEx and UPS labels
- Create, distribute and track access badges
- Submit building maintenance requests as needed
- Complete weekly facilities floor walks for preventative and proactive maintenance
- Support coordination of monthly employee experience events
- Create workplace signage and digital content
- Document Workplace Services processes to assist in standardization
- Troubleshoot break/fix facilities issues as needed
- Execute facilities and office projects that innovate and enhance the employee experience
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.
- 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
- The Clinical Operations Lead is accountable to deliver data-driven, actionable operational and strategic insights for execution of a clinical development program and all associated studies
- Responsible for the strategic development of 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.)
- Provides the operational perspective to the Clinical Development Plan and to trial protocol design, ensuring that leadership is aware of operational considerations and options
- Responsible for driving execution of clinical studies in assigned programs on time and on-budget and for proactive issue management and resolution
- Responsible for the development of the cross functional study/program costs for the Program Team, portfolio process, and financial updates
- Interacts with and influences all levels of management and cross-functional team members to develop strategies and execute plans to achieve program objectives.
- Responsible for executing clinical programs in compliance with quality standards (ICH/GCP, Global Regulations, and KPTI policies and all applicable procedures)
- Responsible for maintaining Clinical Operations business standards across studies (tracking, reporting, agendas/minutes, etc.)
- Responsible for the Clinical Program(s) always maintaining a state of inspection readiness, and act as an expert during regulatory inspections
- Responsible for 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.)
- Leads cross-functional and within function innovation and process improvement initiatives and ensures effective change management within the organization
- Responsible for developing/mentoring clinical operations staff and creating an inclusive and innovative environment where staff and studies/programs will succeed
- Ability to work both at a strategy level as well as hands on as needed for the program
The Executive Director, US Medical Affairs Strategy, Hematology/Oncology will be responsible for owning the development and driving the execution of the Global Medical Affairs strategic and tactical plans.
As an integral part of GMSA leadership team, and in close collaboration with the MSL Field Lead, the incumbent will establish and maintain the relationships with the Key Opinion Leaders and other prioritized external stakeholders. In addition, the Senior Director will have commercial aptitude and/or experience, including proven ability to translate and align commercial and scientific goals and objectives.
As a Karyopharmer, reporting to Senior Vice President of Global Medical & Scientific Afairs, you will positively impact patients’ when you:
- Lead the development and participate in the execution of Global Medical Affairs Strategy and Plan
- Advise on the development of field engagement, HEOR plans, US medical education, publications, and various scientific and medical communication tactics.
- Partner with internal stakeholders to address learning and development needs for the organization.
- Provide input and strategic direction on data generation and life cycle management initiatives.
- Provide medical monitoring and medical oversight for company sponsored Medical Affairs led interventional and observational clinical trials and real-world data generation
- Support cross-functional launch activities
- Prepare and educate internal and external stakeholders on disease, treatment landscape and asset
- Serve as a medical and content expert for internal and external stakeholders
- Play an integral role in the planning and execution of US advisory boards
- Represent Karyopharm at key Global and US medical conferences/meetings
- Provide scientific input and strategic direction to the medical affairs data generation plan, including investigator-sponsored trial (IST)/collaborative studies program for an asset/disease
- Lead the execution of the pre-approval access program if required
- Provide input for Medical and Promotional Review Committees
- Provide scientific/medical input into local regulatory/reimbursement/policy related documents and interactions
The Document Control Specialist will provide assistance for the Document Control program, including day-to-day document processing, document archiving, and supporting continuous improvement of document and user databases.
- Review GxP documents for completeness, consistency, formatting, and adherence to company guidelines
- Facilitate and support document reviews, consolidate comments and redlines, initiate and track document review/approval workflows
- Manage periodic reviews of controlled documents
- Work cross-functionally to manage and complete document revisions
- Maintain Quality records, including training documentation, audit documentation, etc.
- Educate new and existing employees about document control and Good Documentation Practice requirements
- Provide support and guidance to cross-functional colleagues with documentation needs
- Provide technical assistance on the document management and training systems to end users
- Assist with the development of a Quality document archive
- Provide backup support for the GxP Training Program
- Inspection Team member for regulatory agency/health authority inspections
- Assist with internal and partner audits
- Assist with archiving paper documentation in Karyopharm’s document archive (e.g., scanning files, logging in documents, etc.)
The Associate Director, Forecasting & Commercial Analytics will serve a significant role as the owner of the annual Long Range Revenue planning process covering Pipeline, and In-line Product portfolios. Forecasting responsibilities will be inclusive of building disease level, patient based forecast models for Karyopharm disease areas of interest.
This position will be expected to work closely with internal and external cross functional partners including Supply Chain, Marketing, Finance, as well as Business Development. Core responsibilities will be ensuring process in place for the development of Brand level forecasts (patient, unit, dollar) and gaining alignment across departments relative to key assumptions, EPI data sources, and analogue identification and application. The role will also be monitoring actual performance vs Budget and Latest Estimates while ensuring KPI tracking/ dashboarding/reporting is in place. Role will also be responsible for ensuring Competitive Market Events for all disease areas are formally and proactively identified, tracked and assessed on timely basis. Role will also play role in determining what Primary Market Research and Secondary data sources will be needed to inform internal company guidance.
The Associate Director, Forecasting will be a high profile position playing a critical support role to Karyopharm C-Suite, Executive Committee and commercial leadership teams. Success in this role will require a collaborative mindset; experience in Oncology and/or Hematology therapeutic categories while also having the capacity to absorb other disease areas.
Reporting to our Executive Director, Commercial Strategy & Operations, you will positively impact patients’ when you:
- Lead development and implementation of Oncology/hematology market and patient based forecast models & tracking; proactively identify new data sources/methodologies that will enhance decision making & increase forecast accuracy.
- Effectively explain modeling assumptions to key stakeholders including senior leadership and triangulate assumptions with other data and forecasting model to pressure test them and develop “what if” scenarios.
- Implement best-in-class forecast modeling approaches; work with supplier partners, foster strong partnerships in the context of resources, timing and overall goals.
- Integrate forecasting efforts & insights with primary research, competitive intelligence, & analytics insights co-developed with peers across the organization and translate into business impact.
- In partnership with the commercial leadership team; lead the identification and development of key performance metrics to measure and monitor brand strategy and field execution.
- Provide context and forecasting leadership to cross-functional partners (e.g., Finance, Supply Chain) to ensure the potential impact of commercial strategies are well understood and planned
- Lead identification, maintenance, and generation of data references/databases for continuously improving oncology epidemiology, across markets and diseases, partner with the HEOR team as appropriate
The Executive Director, Scientific Communications and Publications will be part of the GMSA leadership team and will be actively involved in strategy development to support Medical and cross-functional goals and objectives. This position will serve as a key collaborator with Global Medical Affairs for coordination of congress and publication planning.
As a Karyopharmer, reporting to Senior Vice President of Global Medical & Scientific Afairs, you will positively impact patients’ when you:
- Drive an integrated Scientific Communications strategy that is aligned with the brand strategy and medical strategy and meets the needs of patients and health care providers
- Ensure the successful execution of the Scientific Communications strategy, including publications (abstracts, posters, manuscripts), congresses (medical booth, symposia), digital content, and Field Medical materials
- Collaborate with Global Medical Affairs and other functions (e.g., public affairs) as well as other departments (e.g., commercial) to ensure the Scientific Communications strategy for the brand/disease state portfolio is aligned cross-functionally
- Demonstrate business acumen and a strong ability to align scientific communications and delivery channels with medical objectives and cross-functional strategic imperatives
- Manage relationships with external authors in the preparation and review of publications for assigned projects, including the management of publication steering committees
- Prepare budgets and forecasts in collaboration with finance and other relevant functions and effectively manage agencies for project delivery within budget
- Ensure USMA activities comply with business guidance, policies, SOPs, OIG, FDA, & PhRMA Guidelines Qualifications Education
- External vendor oversight in managing the planning and execution of scientific communications and publications.
The Senior Manager, Global Publications provides support for the development and execution of global publication plans and medical publications for two programs across Karyopharm in the Hematology/Oncology and Solid Tumor Therapeutic Areas.
As a Karyopharmer, reporting to Senior Vice President Global Medical & Scientific Affairs, you will positively impact patients’ when you:
- The Senior Manager leads in the execution of publication plans for assigned assets, and oversee the execution of scientific publications (ie, clinical manuscripts, abstracts, posters, and oral presentations) that fulfill strategic objectives for the asset.
- Ensure Publication Plan is in alignment with the strategic publication plan as developed by the Scientific Communication Platform lead or Medical Affairs plans as applicable.
- Contribute to writing, reviewing, editing, revising, and placing high quality and impactful scientific and clinical abstracts, posters, oral presentations, and manuscripts.
- Serve as the leader of cross-functional Publications Team(s) for assigned assets, including leading team meetings/discussions and driving the execution of publication plans, incorporating input from key global stakeholders
- Lead tactical execution of publication plans (ie, clinical manuscripts, abstracts, posters, and oral presentations), meeting established timelines and budgets
- Ensure project information in publication records and resourcing tools is accurate and up-to-date
- Coordinate publication committee discussions, including monthly, quarterly and yearly publication update meetings as needed
- Ensure documentation of compliance with authorship and publication guidelines as stipulated by the International Committee of Medical Journal Editors (ICMJE) and Good Publication Practice for Communicating Company-Sponsored Medical Research (GPP)
- Support global medical communication plan development by collaborating with GMSA team
As a Karyopharmer, reporting to the Field Medical VP, you will positively impact patients’ when you:
The Senior MSL is an experienced oncology professional with scientific, clinical, and therapeutic area expertise responsible for providing medical expertise on all the Karyopharm assets in development. The Senior MSL is a highly valuable member of the Global Medical and Scientific (GMSA) team who represents Karyopharm externally by engaging in highly credible scientific discussions with targeted Key Opinion Leaders (KOLs), internal stakeholders, clinical trial investigators, access stakeholders and other healthcare professionals to help support the medical objectives at Karyopharm. We are looking for someone who approaches the role with thoughtful consideration of the future.
This role will support our Great Lakes territory - MI, OH, KY, Nashville, Western PA & Western NY
- Identifies and develops creative, innovative approaches for external engagement
- Partners with leadership to develop strategies that will adapt medical affairs to the evolving external environment
- Understands oncology treatment paradigms, key stakeholders, and healthcare landscape within the designated coverage area (regionally and/or locally) and within assigned institutions.
- Identifies disease concepts and compound characteristics that can be leveraged into product differentiation
- Represents the company at educational events, programs, medical meetings and scientific congresses
- Identify, engage, and cultivate relationships with key opinion leaders (KOLs), clinicians, investigators, and other HCPs within academic and community settings in accordance with compliance guidance for Medical Affairs activities.
- Identifies and engage key KOLs, HCPs, and investigators in scientific exchange on disease landscape & Karyopharm’s assets.
- Serves as a key member of the Karyopharm GMSA team to share actionable insights/learnings to help inform and develop the medical strategy.
- Collaborates with other cross-functional internal team members (i.e., commercial, payer/access, clinical development) to share regional/local insights/learnings and contribute to respective strategies.
- Provides support for congress meetings, including scientific coverage, competitive intelligence, medical booth staffing and external engagements.
- Delivers medical/scientific presentations to internal & external stakeholders.
- Responds to external inquiries and deliver appropriate clinical and scientific information
- Responsible for individual documentation of field engagements and contributes to aggregate reporting of the Field Medical Team activities and value to the company.
- Responds to external inquiries and deliver appropriate clinical and scientific information
- Represents Karyopharm at select scientific congresses and professional society meetings
- Travels to meetings, face-to-face engagements, as required, estimated at 60%.