Karyopharm Therapeutics Inc.

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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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Job Locations US-MA-Newton | US-Remote
We are looking for an experienced lawyer to join us as Senior Director, Legal & Compliance. This position will report to the VP, Legal & Chief Compliance Officer and will advise Karyopharm’s Commercial, Market Access, and Medical Affairs functions on issues related to product commercialization.  If you have a passion for bringing new treatments to cancer patients and a thorough understanding of the laws governing pharmaceutical sales and marketing, we invite you to join our growing team!     We are looking for a personable, practical advisor who can confidently partner cross-functionally.  You will need a deep understanding of both the applicable laws and the day-to-day business of a pharmaceutical company, as well as the strong ability to communicate legal advice to non-lawyers.  You will serve both as a brand attorney, directly advising business stakeholders on new product/indication launches, and as a manager for current and future commercial legal team members.  We welcome candidates who are open to relocation or who can easily to travel to the Boston area multiple times a month.   You will have high visibility throughout the organization, supporting core business activities and providing counsel to cross-functional teams.  You will be empowered to develop strong and positive working relationships with colleagues at all levels.  Prior in-house experience, ability to work in a fast-paced environment, and willingness to be a flexible, business-oriented team player are required.  Karyopharm is a dynamic company with a strong pipeline and we are a team that works collaboratively to contribute meaningfully to the business.   Responsibilities: - Partner cross-functionally to manage all legal advice on commercialization activities, including advising Commercial and Medical Affairs planning and execution of effective and compliant product launch strategies, including review of materials through the Promotional Advertising Review Team and the Medical Materials Review Team - Foster a culture of compliance in Karyopharm’s interactions with healthcare professionals, including the conduct of advisory boards, market research, and other customer contracting - Communicate legal advice to business stakeholders in an authentic and understandable way - Manage current and future commercial legal team members to ensure consistency and quality of advice
Job ID
2022-1930
Job Locations US-MA-Newton | US-Remote
The Senior Manager, Digital Medicine will report to Associate Director, Digital Medicine, and serve as a leader at Karyopharm with a primary responsibility of leading and implementing a science-driven digital strategy across the clinical development programs at Karyopharm. Duties will include developing a platform of novel digital solutions for accelerating the collection of real-world data in pivotal clinical trials, aligned with the company’s commitment for accelerating novel therapies and pushing medicine forward to the next level through disruptive innovation. The ideal candidate is a self-started leader and established champion in the digital health space.   - Design and implement the integration of digital tools into clinical studies and clinical care to maximize patient outcome - Provide strategic leadership and on-going intelligence for emerging technologies suitable to support the development of novel clinical endpoints - Design and deliver validation studies, research projects, and technology development initiatives necessary to evaluate the safety, feasibility, and suitability of wearable sensors and mobile technologies for clinical trials - Provide ongoing leadership on operational considerations related to the integration of digital technologies in clinical trials, ensuring smooth operation, productive execution, efficient communication, data interpretation, and internal alignment across all stakeholders - Produce written research reports, data outputs, validation protocols, regulatory reports, and strategic roadmaps as needed - Effectively partner with key stakeholders, external vendors, and academic collaborators to inspire and deliver value to the business, and leverage opportunities for improving clinical trials through digital innovation and achieving corporate and department goals and objectives - Provide advanced data science expertise to Karyopharm’s digital medicine projects - Recommend and deliver data science solutions using data mining and machine learning tools based on diverse data sources, such as clinical trial endpoints, genomic data, and real-world evidence - Lead the development and implementation of automated clinical data visualization platform in clinical studies and digital data monitoring - Collaborate in a multidisciplinary environment with world leading clinicians, researchers, data scientists, digital medicine experts, and biostatisticians - Coordinate and produce the data required for the evaluation, interpretation, and reporting of clinical trial results for internal meetings, conference presentations, publications, and time-sensitive regulatory submissions  
Job ID
2022-1926
Job Locations US-Remote | US-MA-Newton
Responsible for operational aspects of planning and management of site performance in accordance with departmental expectations. May act as primary liaison between in-house CRAs, field based CRAs and the Clinical Project Manager (CPM). Supports and assists Clinical Project Managers in operationalizing multiple clinical research studies.  - Under supervision may participate/lead in CRA project-specific training.  - Supports preparation and development of materials related to the training and presentations for Investigator Meetings.  - Facilitates CRA project meetings.  - Assist in the oversight of monitoring staff including the tracking and review of monitoring trip reports and escalate any trends with respect to data quality or study conduct to the appropriate CPM.   - Track and report on progress of the study including site activation, patient enrollment and monitoring visits.  - Ensures that all sites are provided supplies in accordance with study expectations.  - Identify potential risks to the enrollment targets based on feasibility analysis in collaboration with the CPM  - Develop PSV /SIV/IMV presentation and other training tools and training materials in support of the project.  - Review and approve PSV/SIV/IMV presentation and other training tools and training materials in support of the project.SR CTM  - Assist in the review of CRO and other third party vendor invoices to ensure that work is performed in accordance with scope of work.  - Ensure that monitoring visits are performed in accordance with the protocol, monitoring plan, and applicable Karyopharm SOPs.   - Under supervision may develop and/or monitor budget for clinical study (investigational sites and vendors)   - Responsible for operationalizing clinical protocols at the site level and ensuring appropriate SOPs are being followed for each process, depending on the study.   - Assists in oversight of the identification and selection of investigator sites..   - Contributes to the clinical review of Case Report Forms, User Acceptance Testing (UAT) and corresponding completion guidelines.  - Assists and/or participates in planning and conduct of investigator’s meetings  - Work with CRAs in proactively maintaining / up-dating essential documents as required, to ensure compliance with protocol and regulations.  - Contact sites as needed for data entry/data quality concerns and alert CRA of any issues prior to the next scheduled monitoring visit.  - Responsible for study start-up activities including development of the first draft of the ICF.   - Assist with the review of protocol, protocol amendments, ICF and CSR documents as required.  - Provide active mentorship of CTA staff to build talent across the department.  - Agenda distribution & minute taking for internal study team meetings.   - Up to 20% domestic and/or international travel may be required. 
Job ID
2021-1924
Job Locations US-Remote
The Associate Director, Health Economics, Outcomes Research (HEOR) should be an experienced professional who will develop and lead HEOR activities to support assigned indications within Karyopharm’s portfolio. The position will work closely with other members within the Global Medical and Scientific Affairs team.   Responsibilities: - Develop AMCP/Global Value dossiers outlining product value based on available evidence and aligned with strategic brand positioning - Conduct health economic modeling such as budget impact modeling, cost effectiveness analysis, and network meta-analyses as needed - Develop and execute real-world evidence generation plan leveraging real-world data from commercially available large-scale datasets or through partnerships with practice sites in the US - Support Global Product Teams in the identification and implantation of appropriate payer-relevant endpoints and patient reported outcome measures into registrational trials. - Conduct literature reviews to identify evidence gaps to support KPTI products - Support the development of field materials containing healthcare economic information - Collaborate with Payer Marketing to fully leverage healthcare economic information for formulary decision-maker messaging. - Develop and lead research partnerships with academic and community oncology practice thought leaders to address key HEOR and medical research gaps. - Effectively partner with internal stakeholders (Medical Directors, Market Access, Development, etc.) at strategic and tactical levels through evidence generation and insight sharing to help the cross-functional team achieve objectives and goals.
Job ID
2021-1923
Job Locations IL-Tel Aviv | IL
Oversees the progress of clinical investigations by conducting pre-study, initiation, interim and close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices. Works closely with the Clinical Project Manager to ensure all monitoring activities are conducted according to study requirements. Please note this position can be remotely based in Israel.   - Participates in the investigator recruitment process. Performs initial qualification visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study, both clinically and technically. - Assists in the preparation and review of protocols, eCRFs, study manuals, and other study documents as requested. - Obtains and reviews regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials including submission if required - Performs study initiation activities; reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF. - Conducts periodic site file audits to ensure compliance with GCPs and accuracy of Trial Master File aAssures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Prepares monitoring reports and letters in a timely manner in accordance with the study monitoring plan. - Performs investigational product inventory. Verifies destruction of unused materials or ensures return to designated location, as required. - Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries. - Serves as primary contact between Karyopharm and investigator Participates in study team meetings providing monitoring updates. - Assists with, attends, and may present at Investigator Meetings for assigned studies. - Performs study close-out visits. - May request site audits for reasons of validity. - Performs other duties as requested. - Up to 75% domestic travel
Job ID
2021-1922
Job Locations US-Remote | US | US-NC | US-CO-Denver | US-Remote
Oversees the progress of clinical investigations by conducting pre-study, initiation, interim and close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices. Works closely with the Clinical Project Manager to ensure all monitoring activities are conducted according to study requirements. Please note this position can be remotely based throughout the US.   - Participates in the investigator recruitment process. Performs initial qualification visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study, both clinically and technically. - Assists in the preparation and review of protocols, eCRFs, study manuals, and other study documents as requested. - Obtains and reviews regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials including submission if required - Performs study initiation activities; reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF. - Conducts periodic site file audits to ensure compliance with GCPs and accuracy of Trial Master File aAssures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Prepares monitoring reports and letters in a timely manner in accordance with the study monitoring plan. - Performs investigational product inventory. Verifies destruction of unused materials or ensures return to designated location, as required. - Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries. - Serves as primary contact between Karyopharm and investigator Participates in study team meetings providing monitoring updates. - Assists with, attends, and may present at Investigator Meetings for assigned studies. - Performs study close-out visits. - May request site audits for reasons of validity. - Performs other duties as requested. - Up to 75% domestic travel
Job ID
2021-1919
Job Locations US-Remote | US-MA-Newton
Karyopharm Therapeutics is actively seeking an experienced professional for our (Associate) Director, Regulatory Intelligence, Science and Policy role who will be a key contributor to our Regulatory strategies across all our development programs.  The incumbent is accountable for shaping and evolving the Regulatory Intelligence, Science and Policy function and Regulatory objectives which support the successful development and launch of new products and lifecycle management opportunities.  This position will report directly to the Senior Director, Commercial Regulatory Affairs. - Develop, build, and evolve the Regulatory Intelligence, Science and Policy function and partner with the respective Global Regulatory Leads to enable best-in-class regulatory strategies for all relevant development and lifecycle management projects - Proactively inform the Company, as appropriate, on Regulatory Intelligence, Science and Policy topics that may have impact on R&D and Commercial objectives - Perform research and compose white papers on relevant Regulatory topics, as needed - Lead and drive internal alignment on Regulatory Policy topics, as required - Serve as delegate of Senior Director, Commercial Regulatory Affairs at external industry association meetings and/or engagements, as applicable
Job ID
2021-1918
Job Locations US-Remote
The Specialist/Manager, Regulatory Affairs reports to the Global Regulatory Lead and works within Regulatory Affairs across programs as well as cross-functional teams to support in executing regulatory strategies. - Accountable for the execution of regulatory strategies including, but not limited to, compiling regulatory submissions such as IND, CTA, Amendments, and support major submissions such as (s)NDA, MAA, variations, etc. - Act as the conduit between external functions and Regulatory Operations to ensure execution excellence of assigned submissions - Lead Regulatory initiatives including Regulatory Intelligence and Regulatory Science projects, compliance activities, and assigned tasks - Maintain Regulatory Strategy Documents for assigned programs - Co-chair Regulatory Subteam with the Global Regulatory Lead - Accountable for submissions such as Annual Reports and Renewals for assigned products  
Job ID
2021-1915
Job Locations US-MA-Newton
Reporting to the Vice President of IT, Karyopharm is looking for a key role in maintaining operational cyber-security defense and response to threats against the enterprise. The Sr. Cybersecurity Operations Engineer will monitor, detect, analyze, and respond to cyber-security events and incidents within the information systems and networks of Karyopharm. This role will also help select, configure, and maintain security solutions and processes to deliver Cybersecurity operational services including intrusion detection and prevention, situational awareness of network intrusion and security events, data spillage, and associated incident response actions. They, working with the VP of IT, will be responsible for forwarding the overall Security Program as well as the current and potential future risk areas that may present themselves, based on business area or requirement/regulation. Individuals that will be successful in this role will be comfortable working in a regulated environment, be able to work independently, and have strong problem-solving skills. Long term success will be achieved by an individual who has a strong desire for continuous learning and professional growth and can increasing influence Security and Good Security Practices within the organization. - Provide operational support to all security technologies - Review and assist in selection/configuration of security technology - Monitor and analyze Information Systems security logs and associated incidents. - Respond to alerts or information from internal security tools - Interpret alerts and escalate issues that cannot be resolved immediately. - Stay current on emerging threats and possible attacks on KPTI information systems, as well as develop mitigation approaches to said issues. - Conduct technical analysis of security products, patches, issues, and mandates necessary to support our continuous improvement of IT Security. - Maintain Data Privacy information, internal and external to KPTI - Contribute and Provide Updates to Cyber Security Training for Internal Staff - Manage small Security related projects from inception to completion - Participate in cross functional Security Council for forwarding overall Security Program - Contribute to overall Cyber Security and Privacy Governance for KPTI.
Job ID
2021-1914
Job Locations US-MA-Newton | US-WI | US-IL
As a member of the field-based medical affairs team, the (Senior) Medical Science Liaison (MSL) will function as an extension of the medical affairs organization and will be responsible for developing and managing professional relationships with key influencers in community hematology/oncology offices, including treatment centers and healthcare networks. This position provides formal education presentations and informal scientific exchange with community influencers to support the needs specifically related to its hematology/oncology portfolio.   Responsibilities: - Develop and maintain relationships with key community influencers and leaders within hematology/oncology therapeutic area - Deliver clinical presentations to varied audiences with effect - Support medical affairs and general program management - Utilize approved resources to address customer needs, ensuring they are following all guidelines and regulations - Lead and/or participate on committee/project teams which support COL strategies as delegated by COL leadership - Gain feedback through field interactions with HCPs to uncover collaboration opportunities and pair customer’s unmet needs with available internal resources - Assume a leadership role by teaching, coaching, and mentoring new hires and/or less experienced COLs and by assuming responsibility for special projects as they arise
Job ID
2021-1908
Job Locations PL | AT
SUMMARY:   The European Medical Advisor is the main point of contact for all Medical and Scientific Affairs activity within the assigned geographic area and is responsible for adapting Global Medical strategy in setting up local medical strategic plans and tactics in covered territories. This individual will be responsible for the identification and engagement of a targeted group of Global, European, Country thought leaders/healthcare professionals (HCPs), as well as important HCP Stakeholder groups. This position provides consistent delivery of educational and compliant scientific information in support of Karyopharm’s pipeline.   - Ensure that all activities and interactions are conducted with due regard to all applicable country and European laws, regulations, guidelines, codes of conduct, Company policies and accepted standards of best practice. - Responsible of the development and execution of the country medical launch strategy and tactics in line with the Company and GMSA strategy. - Identify and develop relationships with community/academic thought leaders along with treatment advocates within the assigned geographic area. - Provide scientific and technical leadership to ensure professional and credible relationships with thought leaders and external experts of strategic importance. - Ensure a strong medical and scientific presence for Karyopharm in key academic centers and/or key reference hospitals by facilitation of research and educational initiatives, while supporting requests for medical and scientific information on products or areas of therapeutic interest to Karyopharm. - Serve as a point of contact within the Medical Affairs team for thought leaders and external experts within an assigned geographic area in order to satisfy their needs for scientific knowledge in a therapeutic area and, when requested, relevant Karyopharm medicines, to support their safe, effective and appropriate use. - Deliver credible presentations on scientific matters to physicians, individually or in groups (meetings, clinical sessions, etc.). - Serve as Karyopharm’s scientific representative to the medical community and facilitate the appropriate exchange of scientific information. - Signaling and assessing preclinical and clinical research possibilities, setting up, supervising, and co-reporting clinical studies/trials. - Utilize approved resources to address customer needs, ensuring they are following all guidelines and regulations. - Ensure continuous medical support in any patient early access programs. - In partnership with clinical operations, coordinate feasibility and investigator selection in his/her respective countries, support trial awareness, enrollment, and identification of potential sites/investigators for clinical trial participation. - Serve as the key liaison for all aspects of investigator sponsored research. - Facilitate medical and scientific field intelligence – for example, competitor research and medical strategies, educational activities, structure and function. - Attend relevant scientific meetings and conferences. Collaborate with internal stakeholders to develop summaries of key data and other scientifically relevant information to inform Karyopharm strategic priorities and initiatives. - Communicate therapeutic market trends which may impact Karyopharm’s pipeline. - Lead and/or participate and support advisory boards, steering committees and Investigators meeting. - Facilitation of advisory boards – participant selection, agenda setting, chairing of board on presentation of scientific data. - Lead and/or participate on committee/project teams which support Senior Medical Advisors’ strategies as delegated by the Head of European Medical Affairs - Gain feedback through field interactions with HCPs to uncover collaboration opportunities and pair customer’s unmet needs with available internal resources. - Coordinate medical input into health technology reviews in collaboration with market access and HEOR. - This position is a field based international role as such the person is expected to be able to travel and be active with in field duties 70% of the time.
Job ID
2021-1903
Job Locations US-MA-Newton | US-Remote
Karyopharm is looking for an energetic, entrepreneurial, and resourceful Senior Director, Strategic Initiatives reporting to the VP, Strategic Initiatives & Launch Excellence within the office of the President and CEO.  The Senior Director, Strategic Initiatives will partner with key stakeholders to facilitate and support the Karyopharm Executive Leadership Team. This role requires a leader who combines executive presence, emotional intelligence, and a strong work ethic.  This high caliber individual will facilitate a variety of key strategy and change management initiatives at the corporate level across functions (Commercial, Development, etc.).   The successful candidate will have: - Demonstrated ability to deliver results through exceptional team collaboration and influence in a highly matrixed environment. - Experience leading change management initiatives at the corporate level, including the researching, implementation, and assessment from start to finish. - Thorough understanding of commercial operations; broad experience across several disciplines preferred (i.e., R&D, regulatory, business development, manufacturing, strategy, etc.).   Responsibilities:  - Partner directly with our Executive Leadership Team to direct and manage a broad range of projects to ensure organizational effectiveness and attainment of strategic priorities. - Lead effective meetings to promote quality of decision making and follow-up. - Track key initiatives by monitoring progress towards goals, ensuring follow-through on the part of relevant players and sustaining momentum needed to drive these initiatives.
Job ID
2021-1902
Job Locations US-MA-Newton | US-Remote
The Associate Director/Director, GXP Auditing is responsible for the management of all activities related to the successful operation of the global internal and external GXP audit program.   • Development and management of an effective risk-based internal and external GXP audit programs • Manage the development, implementation, and maintenance of standard operating procedures (SOPs), work instructions (WIs), checklist and templates that govern the internal, external, and GXP vendor audit program. • Create annual internal and external audit schedules, assign responsibilities to the audit team members, and ensure audits are performed according to the audit schedule. • Select and oversee contract auditors. • Provide training to the audit team members and conduct co-audits, as required. • Conduct internal and external audits, as needed. • Review audit reports to ensure they are clear and cover the most important information to support successful development of corrective and preventive actions (CAPAs). • Identify key performance indicators (KPIs) and metrics for the audit program to ensure compliance with SOPs/WIs, applicable regulations/standards, and continuous improvement. • Support vendor qualification activities including the review of questionnaires and other applicable documentation to support the assessment of vendors. Escalate critical findings to the Head of Quality. • Ensure the approved vendor list (AVL) is maintained and inspection ready at all times. • Drive closure of CAPA resulting from audits, as needed. • Assist in inspection readiness activities. • Participate in regulatory audits, PAI readiness audits and inspections as directed by QA Management. • Participate in Quality team projects, programs, and initiatives, as required. • Up to 30% travel, domestic and international required.
Job ID
2021-1897
Job Locations US-MA-Newton | US-Remote
Reporting into the CFO, the Vice President of Investor Relations will develop communication strategies addressing the investor community, craft cohesive communications plans both internally and externally. The SVP will develop and maintain close relationships with key investors and analysts by communicating Karyopharm’s story on a continuous, transparent and consistent basis, in compliance with corporate policies and securities regulations.   - Develop, implement, and manage a strategic plan for investor relations that helps ensure fair valuation of the company and accurate understanding of the company story and evolution with both the sell-side and buy-side - Identify key issues and opportunities for investor communications and develop innovative investor relations strategies and programs accordingly, ensuring investor relations initiatives are effectively linked to corporate and department goals - Develop and lead review of investor-facing communications materials, including corporate announcements, investor presentations, press releases, conference call scripts, Q&As, and backgrounders - Partner with numerous functions in the company including but not limited to commercial, medical affairs, research and clinical development, to enable accurate and optimal creation, evolution and delivery of key messages, and to ensure that investor communications are aligned with communications across all external audiences - Ensure executive team is up to date on investor and analyst perceptions of the company; recommend and implement any necessary course corrections in messaging and relationship management - Identify targeted institutional investors on an ongoing basis and build relationships - Monitor industry and competitor developments, alert management and prepare proactive and reactive plans as needed - Monitor industry-wide investor relations developments and provide guidance when necessary - Provide accurate, consistent and timely responses to all external inquiries from investors, analysts - Serve as the corporate liaison to institutional investors and analysts
Job ID
2021-1896
Job Locations US-MA-Newton | US-Remote
- Establish relationships with internal stakeholders to ensure the highest level of service - Support sourcing needs of the commercial organization and other departments as needed - Lead RFP process and business negotiations to support the needs of internal stakeholders - Monitor and support supplier onboarding and implementation of agreements - Follow oversight SOP and use internal tools to manage vendor relationships - Lead vendor performance evaluations - Lead escalation to resolution for both internal stakeholders as well as vendors - Provide input on strategy, support department development, implementation of processes and systems, and review of vendor management policies and procedures - Oversee vendor assessments and scoring - Work closely with finance and legal to effectively negotiate business terms - Support implementation of cost savings measures and transparency with vendors - Evaluate potential risks in the engagement of new vs. existing vendors - Coordinate and lead governance structure with high visibility vendors - Hire and manage department personnel -                                                            
Job ID
2021-1889
Job Locations US-Remote | US | US-OR | US-WA
The Regional Director, Field Based Medical Affairs (West) will be responsible for integrating scientific expertise and product knowledge to ensure successful implementation of the Company's marketed and emerging product portfolio. This position will be responsible for managing and leading a team of 8-10 Medical Science Liaisons (MSLs), cultivating, implementing and managing scientific expertise and knowledge with brand strategies to ensure successful communication, education and implementation the Company’s marketed and emerging product portfolio. Territory is the western half of the US, including TX. The hire can work remotely from any state in the western half of the US.   - Lead, manage, mentor and provide continuous strategic and tactical vision, guidance and training to a group of highly qualified medical professionals - Facilitate scientific development of marketed and pipeline compounds at research centers and secure our presence in the related therapeutic areas - Contributor in cross-functional setting in close alignment with the Company’s Medical Affairs and Commercial groups - Evaluate, interview and hire prospective MSL candidates - Participate in training and on-boarding of new hires - Provide technical expertise to other members of the organization - Take the initiative and perform tasks in a self-directed manner - Enhances cohesiveness among MSL and Global Medical and Scientific Affairs team members – providing a respectful, inclusive environment - Proactively offer ideas and solutions to enhance the productivity of the MSL Team - Spearhead strategic initiatives within the MSL organization in collaboration with GMSA Leadership - Deliver updates and presentations to Senior Leadership - Develop best practices for the MSL team - Deliver scientific/clinical presentations at advisory boards, consultant meetings, and/or facilitation of breakout sessions - Deliver scientific/clinical presentations to payer groups and other managed market customers - Represents MSL team on select clinical/medical study teams
Job ID
2021-1887
Job Locations US-MA-Newton | US-Remote
Manager, GCP Compliance will be a critical team member who contributes to implementation of risk-based GCP and compliance oversight. This person will be responsible for the planning, identification, coordination, execution, reporting and closure of CGP Compliance issues in support of clinical programs. The incumbent is also responsible for supporting the GCP auditing plan and assisting its management.   - Conduct Regulatory Submission Review such as Investigator Brochures (IB), Development Safety Update Report (DSUR), Clinical Study Reports (CSRs), NDAs, Clinical Protocols, ICFs. - Conduct/Lead Internal System, process and documentation Audits to ensure compliance to the Code of Federal Regulations, the International Conference of Harmonization (ICH), applicable regulations and company SOPs. - Conduct qualification or routine vendor audits of Clinical Research Organizations, Clinical Laboratories, Phase I Units, Imaging Vendors, eTMF Vendors, Investigator Sponsored Trials - Assist in the management and closure of GCP CAPAs, including metrics tracking and reporting. - Participate in QA Review of Internal SOPs, driving toward establishing and maintaining harmonized and cross-functional SOPs. - Perform training and education internally in global GCP standards, and externally as required (Investigator Meetings, CRA Trainings, Pre-Approval Inspections, etc.) - Represent GCP QA in assigned weekly protocol project team meetings. - Assist with the preparation and hosting activities during regulatory inspections and investigations conducted by various regulatory authorities, including the coordination of timely responses. - Support Clinical QA projects.
Job ID
2021-1886
Job Locations US-MA-Newton
- Accountable for the prescribing information and related materials (referred to as “labeling”) of assigned product(s) for the purpose of regulatory submissions, maintenance and compliance - Accountable for the oversight and compliance of product artwork for the assigned product(s) - Responsible for the development and maintenance of the product labeling in collaboration with internal stakeholders - Partner with internal stakeholders to develop and maintain the Core Company Data Sheet - Contribute to applicable regulatory strategies for all projects with impact to labeling - Develop, champion, and lead all applicable internal Committees and the associated processes with respect to approvals of labeling changes - Provide support to review advertising and promotion and/or medical materials through PART and/or MMRT, as needed - Provide support and contribute to Regulatory Intelligence, Regulatory Science, and Regulatory Policy with focus on labeling; and when necessary, conduct detailed analyses - Serve as an internal expert on FDA and EMA labeling requirements  
Job ID
2021-1882
Job Locations US-MA-Newton
The Pharmacovigilance (PV) Compliance Associate/Specialist reports to the Manager of PV Compliance and performs specific work delegated by Pharmacovigilance management.  Responsibilities include but not limited to: - Support deviation documentation, training and CAPAs - Assist with PSMF maintenance - Assist with establishing an inspection readiness process for pharmacovigilance - Assist with audit/inspection responses from Pharmacovigilance and external partners/vendors and evaluate proposed corrections, corrective actions, and or preventative actions for compliance with applicable regulations, guidelines and Karyopharm policies - Track and Monitor compliance (ICSRs to Health Authorities, Partners, & Central Ethics Committees) - Utilize PVQ to generate metrics and reports for senior management - Monitor activities of CROs/business partners to ensure adherence and compliance with applicable SMPs, KPIs/Metrics, PVAs and other contractual agreements - Interface with internal and external stakeholders and ensure that the appropriate contact points are established with the other groups (e.g., Quality, Regulatory Affairs, etc.) to respond and address gaps or compliance issues that need resolution by team Associates - Assist in monitoring department adherence and compliance regarding training with SOPs, and other PV specific procedural documents
Job ID
2021-1874
Job Locations US-MA-Newton
  Karyopharm is looking for a Senior IT Business Partner to provide partnership and oversight of various business area IT operations and associated application platform(s) operations, strategy, and technical resourcing globally. This role will identify and influence technology selection, solution approaches, use, and adoption, as well as propose and lead strategic technology initiatives across the organization.  Working with peers, IT Operations, Data Services, and external managed services, this role will support the day-to-day delivery needs within the business both with individual contribution as well as associated managed services.   - In order to maintain a safe work environment, Karyopharm requires all employees to be fully vaccinated against the Covid 19 virus at the time of employment. - Partner with various business leaders to identify & prioritize needed business capabilities and create corresponding technology roadmaps - Collaborate across IT Business Partners to identify synergies and help establish aggregated technology roadmaps that drive an overall technology vision and optimize the technology footprint - Ensure a common architecture is consistent with long-term business objectives by participating in the analysis, evaluation, and development of long-range strategic technology planning. - Assist in managing the various application portfolios across all business areas within Karyopharm - Oversee application development, implementation, and configuration through a structured project methodologies to successfully deliver internally developed, purchased/customized, and SaaS solutions related - Collaborate with IT leadership team to apply best practices in integration and represent Enterprise Applications during envisioning sessions with other IT Groups - Establish and implement resource strategies and plans to meet the highest priority demand, allowing for flexibility in capacity (scaling up and down as needed) - Develop and manage training strategy and plans to improve team performance - Leverage project roadmaps and drive short- and long-term actions to address skills and resource capacity planning - Participate in establishing sourcing from 3rd party vendors to create capacity flexibility and scalability. Manage vendors ensuring appropriate measures are in place to monitor and drive vendor performance - Drive continuous improvement of KPTI’s business systems to increase effectiveness and efficiency, as well as improve overall internal customer experience. - Establish and maintain positive relationships with strategic development partners and with internal business partners - Manage vendor relationships for Regulatory and R&D-related applications - Oversee the development of statements of work, contracts, managed service and service level agreements with vendors, and strategic sourcing related to the area of focus - Develop and manage effective application and support standards for both IT Operation handoffs and the user community
Job ID
2021-1867