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-Remote | US-MA-Newton
Under the guidance and leadership of the Senior Director, Scientific Communications; assist, manage and/or lead: - Create scientific tools and materials in support of the oncology business including, but not limited to educational/training materials, disease state, and product slide kits, advisory board slides, etc. for both internal and external customers - Accountable to the development of high quality and high impact scientific content support for medical affairs, clinical development and other internal customers. - Provide clinical / scientific information, input, interpretation, and strategy as needed - Partner with the other team members on deliverables which include congress planning, congress materials, advisory boards, steering committees, and other Global Medical Scientific Affairs (GMSA) tools and resources - Help create pre-congress materials (briefing books, content analysis etc.); and post congress executive summary report - Manage the execution of these plans through a cross functional team setting - Other duties as assigned
Job ID
2021-1730
Job Locations US-Remote | US-MA-Newton
SUMMARY: The Grants Program Manager in Global Medical and Scientific Affairs (GMSA) serves as a the program lead and will support the Global Head of Medical Education RESPONSIBILITIES:  - Leading in the operational development and implementation of effective, efficient and compliant processes as well as review of medical education grants requests and development grants; including departmental processes, procedures, reporting and metrics - Be willing to identify Karyopharm’s growing program needs and be willing to make recommendations on process improvements as well as lead process changes with cross-functional teams - Be an optimal communicator and team player with professionalism excellence among internal and external stakeholders. - Make inquiries regarding Karyopharm’s policies, procedures, practices and funding of independent medical education and development grants - Assist in the development of departmental and cross-departmental optimal notification and communication standards, such as response, professionalism and turn-around time for incoming grant requests and other grant-related questions or information - Identify and lead special projects aimed at continuous improvement, streamlining, effectiveness and efficiency of Medical Education grants functions and operations, with a focus on the development grants processes; continuously improving departmental resources, including communications - Aggregate medical education information for both qualitative and quantitative measures - Conducting various program analyses and develop status reports as needed - Manage the medical education budget with the Global Head of Medical Education - Work collaboratively and efficiently with all internal and external customers, partners and other stakeholders - Ensure assigned goals and objectives are met and assigned projects are completed to high standards and within budget - Act as a lead contact and subject-matter expert regarding Medical Education operations, processes, procedures and systems as they relate to medical education and development grants processes - Stay abreast of the external environment: industry and market trends, regulatory developments, state-of-the-art medical education, etc. Identify and recommend implementation of appropriate opportunities for continuous improvements and streamlining of medical education grant processes, procedures, systems, tools and reporting - Participate in the enhancement of processes, procedures, workflows and systems that ensure impeccable communications, careful evaluation, meticulous record-keeping and timely responses to grant applications, both for medical education and development - Guide management and cross-functional team members and Grants Committee chairs with all medical education operations, processes, procedures, systems and the like - Assist with development of and/or delivers training and coaching of internal and external parties in medical education policies, procedures, practices, reporting and other tools. Includes how these relate to development grants processes - Work with Development Grant Committee chairs to make recommendations with respect to overall committee objectives and budget - Be willing to run program analyses for optimizing budgets - Work with medical education team management, Development Grant Committee chairs and other team members to continuously monitor Development Grant Committee processes, establishment of criteria and objectives, continuous optimization of development grant processes, procedures, systems and other tools and resources to ensure optimal compliance, effectiveness and efficiencies - Manage development grants submitted through Karyopharm systems: - Reviewing incoming grant requests for appropriateness with development therapeutic areas of interest and with Karyopharm's policies & procedures - Managing the exchange of questions and responses on behalf of the Committee with respect to incomplete or unclear applications or where further information may be required - Supporting the management of distribution of grant applications to grant review committee members for review prior to the grant review committee meeting - Seeking to process each grant within the established turnaround time - Ensuring that status updates are sent to grant applicants when delays beyond established turn-around times may occur - Triaging or declining grant requests that do not fall within strategic categories - Support Committee chairs in planning, scheduling, budget summary and meeting management - Represent medical education program operations on various teams. - Proactively provide recommendations for optimal workflow efficiency and compliance - At all times, follow pre-established processes, procedures and systems to ensure careful evaluation, record-keeping, optimal communications and timely response to grant applications - At all times, maintain records regarding the submission, review, approval and issuance of development grants, as these pertain to multiple Karyopharm therapeutic areas - Communication/Other: - Coordinate responses to unsolicited requests for clinical accuracy review from external providers and/or faculty or other external parties. Ensure that such questions or inquiries are forwarded to the appropriate personnel.  - Follow-up to ensure timely responses have been given - Coordinate other requests for non-financial assistance, such as faculty recommendations, invitation distribution and mailing lists. Collaborate with internal stakeholders to ensure appropriate triage and timely response to provider requests - May support manager and other team members in completing and distributing regular and ad hoc reporting on general medical education activities, budget and status - Work closely with operations project manager, as and when appropriate or otherwise requested, to ensure team members have direct and immediate access to needed resources and information. - May also coach and mentor cross-functional team members regarding medical education
Job ID
2021-1729
Job Locations US-Remote | US-MA-Newton
SUMMARY: The Project Manager and Medical Review Operational Team Lead, Global Medical and Scientific Affairs (GMSA), serves as the key coordinator for processes of Medical Review Committee materials. ROLES AND RESPONSIBILITIES: - Serve as the key coordinator and logistics project manager for GMSA operations team for scheduling, collating, coordinating meetings, and moderating the Medical Review Committee meetings and forming agendas for submitted materials - Assist in the development of departmental and cross-departmental optimal notification and communication standards, such as response, professionalism and turn-around time for incoming medical review submissions and other medical review-related questions or information - Ensure submitted materials are routed to Karyopharm’s medical review repository / systems (VEEVA) - Coordinate and facilitate the Medical Review Committee meeting to include relevant key stakeholders for that distributed agenda - Accurately document any requested changes and/or edits to Medical materials and distribute those changes to submitters for verification - Work with relevant team members and stakeholders to ensure requested changes by the committee are made and completed - Oversee, track and ensure annual re-review of all materials - Provide input into operational efficiencies and tactics that are employed in Karyopharm’s Medical Committee review processes - Optimize the utility of and measure the impact of tools and resources are used and/or needed in order to report gaps/needs medical committee review stakeholders. - Abide by all pertinent compliance regulations, standard operating procedures, and other policies. - Identify and lead special projects aimed at continuous improvement, streamlining, effectiveness and efficiency of Medical Review needs regarding functions and operations, with a focus on the optimizing processes; continuously improving departmental resources, including communications - Participate in the enhancement of processes, procedures, workflows and systems that ensure impeccable communications, careful evaluation, meticulous record-keeping and timely responses to medical review materials and finalization - Work closely with cross-functional stakeholders, as and when appropriate or otherwise requested, to ensure team members have direct and immediate access to needed resources and information. - Work with medical review committee team members and other relevant team members to continuously monitor processes, establishment of criteria and objectives, continuous optimization of medical review processes, procedures, systems and other tools and resources to ensure optimal compliance, effectiveness and efficiencies
Job ID
2021-1728
Job Locations US-CA
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. This is a remote position based in California.        RESPONSIBILITIES: - 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
2021-1727
Job Locations US-MA-Newton
The Pharmacovigilance Scientist supports the medical component of pharmacovigilance activities including: surveillance activities providing scientific/clinical PV expertise with a focus on the identification, evaluation and management of safety risks for Karyopharm products.  He/She collaborates closely with the safety physician and cross-functional partners to evaluate and actively manage risks in accordance with global regulatory frameworks. - Organize and perform independently or collaboratively as necessary, the relevant safety data analysis for Safety Review meeting; ensure adequate documentation of meeting minutes - Create and maintain an effective signal tracking process that fully documents signaling activities and can be used for regulatory inspection - Support other function teams for Karyopharm investigational products; serve as PV expert and liaise with Clinical Operations, Clinical Development, Biostatistics, Regulatory Affairs, Contract Research Organizations, and other entities as needed - Contribute to health authority and other safety related query responses - Support study teams for Karyopharm investigational products; serve as PV expert and liaise with Clinical Operations, Clinical Development - Demonstrate knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.) - Ensure compliance with Karyopharm and PVG & Risk Management policies and procedures - Prepares aggregate safety reports (e.g. DSURs, PSURs, RMP), including project management, safety database requests, understanding and writing the content, assimilating information from other groups, and quality checks - Plans and executes literature surveillance - Provide leadership in the development, implementation, and maintenance of robust procedures for the planning, preparation, and submission of high-quality safety reports
Job ID
2021-1724
Job Locations US-OR-Portland
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. - 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  
Job ID
2021-1723
Job Locations US-CT-Hartford
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. - 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  
Job ID
2021-1720
Job Locations US-Remote | US-MA-Newton
The Manager/Senior Manager, Clinical Supply is responsible for supporting multiple global Karyopharm clinical trials, expanded access programs, and Investigator Sponsored Trials (IST). They will be working closely with the Clinical Supply Associate & Managers, Clinical Operations, and Quality Assurance, to develop clinical supply chains for each assigned study, to ensure that clinical supplies are available in an uninterrupted fashion, and to maintain study documentation in an audit-ready status. This position will also be responsible for department process improvement initiatives.  Other duties include: - Review clinical trial protocols and understand impact on supply - Partner with Clinical Operations to identify demand assumptions, such as enrollment rate, number of sites, number of countries, etc. - Create, review and update the clinical supply and demand plans based on strategic elements/study forecasts from Clinical Operations for studies and/or programs - Participate in cross-functional Project Team Meetings - Ensure changes in supply configuration, trial design, enrollment timelines, manufacturing availability and regulatory requirements are considered - Monitor inventory levels at depots and clinical sites through the life of a trial; take preventive actions to avoid potential supply issues - Manage label development process and packaging timelines - Coordinate US and international distribution and logistics with CMOs - Develop IRT and participate in User Acceptance Testing - Develop and maintain applicable metrics - Review and update SOPs and identify the need for establishing new departmental procedures - Oversee the creation of manual study drug shipments, inventory reporting and maintenance, AoR tracking and filing, and drug reconciliation, returns, and destruction - Maintain traceable documentation within TMF and other electronic document systems created from multiple GxP activities e.g., labels, production batch records, temperature excursions, QP releases, vendor minutes, AoR, and expiry related MTFs - Develop strong internal collaboration with stakeholders to ensure deliverables are met per often aggressive timelines. Being proactive and following through are essential key attributes for this position - Develop job knowledge by participating in educational opportunities and engaging in professional organizations - Create study-specific supply chain plans - Manage Clinical Supply Associates & Managers, as applicable with study elated tasks. - Manage and collaborate with Clinical Supply vendors to ensure that study timelines are met - Assist in department budgets
Job ID
2020-1713
Job Locations US-MA-Newton
The Senior Scientist/Principal Scientist, Research & Development at Karyopharm is responsible for integrating basic science, translational research and clinical development objectives into a comprehensive strategy to achieve the company’s scientific objectives.  Key responsibilities include the planning, implementation, and scientific oversight of collaboration research activities in support of the company’s scientific objectives. In this role, you will be is directly involved with development of Karyopharm drug candidates in close communication and collaboration with investigators, academic researchers and internal stakeholders and participates in writing, reviewing and approving various abstracts, presentations and publications for scientific meetings and other internal and external communications.  This position is responsible for leading relationships with key pre-clinical and clinical investigators that have a stake in Karyopharm outcomes and for championing scientific communications inside and outside of Karyopharm. May lead cross-functional team in the Research and Translational Medicine Department. A small portion of responsibilities include laboratory work.   PLEASE NOTE: The successful candidate must reside in the Boston, MA area   RESPONSIBILITIES: - Plan, implement and oversee scientific aspects of specific collaboration activities relevant to Karyopharm research and development objectives - Design and analyze in vivo studies of disease models in animals to be conducted with CROs. - Provide scientific and technical support to investigators, collaborators and internal stakeholders - Collaborate with Biology, Translational Research, Toxicology, Clinical Operations, Data Analytics and other Karyopharm functions to support preclinical and clinical research objectives - Present data at key scientific meetings/conferences regarding company's products and research - Develop in-depth knowledge of therapeutic areas, current medical practice and industry regulations in order to ensure best practice across all activities - Laboratory work requires the design, conduct and analysis of in-vitro experiments to facilitate drug discovery and development of Karyopharm’s programs and the performance of gene expression and functional studies while using various molecular biology and biochemical methods as cell transfection, knockdown experiments, isolation of DNA, RNA and performing qPCR, Immunoblots and immunofluorescence assays - Laboratory work will be conducted independently and/ or while mentoring others
Job ID
2020-1712
Job Locations US-MA-Newton
SUMMARY: The Clinical Research Scientist (CRS) position serves a key role within the Clinical Development R&D team, reporting to the Head of Clinical Research Science/Senior Medical Director.  The CRS works closely with the assigned study team(s) and medical director(s) to support the activities associated with one or more clinical studies. The CRS leads or co-leads a study or study activities. This position collaborates with clinical team members as well as with functions outside of clinical to provide high quality and timely deliverables. The CRS is responsible for achievement of personal goals which support study team, project team, and corporate goals. RESPONSIBILITIES: - Lead or support assigned study level activities for 1 or more clinical studies with minimal supervision; may lead or co-lead a study - Thorough understanding of assigned protocol and protocol requirements - Understands work to be done; plans ahead - Lead/Co-Lead or Support study start-up/conduct/close-out activities as applicable - Preparation, storage, maintenance of clinical documents (TMF) - Protocol development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments, and ensuring high quality final document) - Perform medical monitoring duties, under the supervision of the medical director, depending on the qualifications and experience of the candidate. Should be appropriately trained and fully aware of all aspects of the drug under investigation and the requirements of the protocol, including any annexes and amendments. In order to function as a medical monitor, the candidate should have adequate medical, pharmaceutical, and/or scientific qualifications, and clinical trial experience. - Review and validation of clinical study reports (CSRs); thorough understanding the connection between the data and the CSR - Author/coordinate and review Regulatory Documents (e.g., IB, Briefing Books) - Author/Review Informed Consent Forms (ICF); review/support finalization of regional and site ICFs as needed; ensure high quality, appropriate reading level text, and alignment with protocol) - Planning of site and CRA training; including logistics, materials and presentation - Country/site selection activities - Collaboration with Clinical Operations for budget preparation, CRO scope of work, etc. (i.e., review and provide feedback on activities/instructions/deliverables related to study data, IVRS, central labs, patient reported outcomes) - Study committee (e.g., DMC) activities such as charters, meetings, presentation preparation - Investigator Meeting and SIV planning/facilitation/presentation - Activities related to data generation and validation, including CRF creation, clinical data review, communication as needed to resolve data queries, draft/update/review data review plans, support Clinical Research Physician in data review (generation of reports, action plans, trend identification), etc)   - May support clinical development planning (assist with analysis of data and review of literature to support future planning) - Collaborate with study team members (Clinical, Clinical Operations, Data Management, Statistics, Drug Safety, IMSC, Regulatory Affairs, Translational Medicine and Project Management) to ensure that key milestones are met on time and with high quality - Provide guidance and scientific expertise within team, across department, and across functions - Lead the planning and preparations for external/stakeholder meetings (e.g., IMs) - Present data/information to external investigators or study staff (e.g., SIV presentations) - Identify and liaise with external partners - Identify, escalate current/active/future issues; propose and enact solutions  
Job ID
2020-1708
Job Locations DE-München
The Manager, Regulatory Affairs reports to the VP, Regulatory Affairs and works within Regulatory Affairs across programs as well as cross-functional teams to support in executing regulatory strategies. - Works with the Regulatory Leads to execute 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. - Perform Regulatory Intelligence activities to support both development and commercial regulatory projects - Digest and present relevant regulatory guidance documents to the Regulatory Team and/or cross-functional project teams - Accountable for submissions such as Annual Reports and Renewals  
Job ID
2020-1704
Job Locations US-MA-Newton
The Manager, Regulatory Affairs reports to the VP, Regulatory Affairs and works within Regulatory Affairs across programs as well as cross-functional teams to support in executing regulatory strategies. - Works with the Regulatory Leads to execute 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. - Perform Regulatory Intelligence activities to support both development and commercial regulatory projects - Digest and present relevant regulatory guidance documents to the Regulatory Team and/or cross-functional project teams - Accountable for submissions such as Annual Reports and Renewals  
Job ID
2020-1700
Job Locations US-MA-Newton
Karyopharm is looking for a Senior IT Business Partner to provide partnership and oversight of the IT Commercial 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 Commercial Business space.  Working with peers and Data Management, this role will support the day to day delivery needs inside the Commercial space both with individual contribution as well as associated managed services.  - Partner with Commercial 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. - Manage the Commercial IT Portfolio, including, but not limited to understanding and managing technical debt, establishing cross-application integration strategies, and ensuring compliance and security through SDLC, as well as, meeting internal and regulatory requirements - 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 Commercial-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
2020-1687
Job Locations US-MA-Newton
The Senior Director, Business Development & Alliances will support the execution of global partnering activities of Karyopharm Therapeutics. The Senior Director is also responsible for ensuring that major operational partnerships are proactively and effectively managed. The Director will develop excellent relationships internally and externally in order to support and drive business development and alliance activities.  This individual will also play an active role in negotiations and transactions for potential collaborations and key assets Karyopharm is seeking to in-license or acquire.   - Develop, manage and serve as a leading contributor in executing Karyopharm’s Business Development Strategy - Establish and nurture close partnerships with key stakeholders and related governance groups domestically and globally to enhance inter-company and cross-regional review and consideration of potential opportunities. - Lead process to gain early domestic and/or global access to promising/emerging or existing technologies and assets that advance the company’s interests in all phases of the R&D and commercial continuum in close partnership with Karyopharm. - Responsible for the entire licensing process, i.e. identification, evaluation, negotiation and implementation of new business opportunities of significant value and working with related functions to provide a comprehensive analysis of available partnering options to select the best possible partner and model for a relationship in our therapeutic areas. - Lead search and evaluation efforts for specific therapeutic areas to proactively identify and solicit new strategic research partnerships or in-licensing/acquisition opportunities with biotech and pharmaceutical companies, academic institutions or non-profit research organizations - Perform strategic and financial analysis on global and regional transaction opportunities - Coordinate development and commercialization strategy with Karyopharm alliance partner(s) along with tactical execution - Direct specific alliance agreement and governance activities, including procedures for decision making, project team meetings, data exchange, etc. - Manage contractual obligations, such as milestone payments, and advise collaboration participants on how the partnership contract should be implemented - Track progress of alliances, including coordinating the definition and reporting of the KPIs, and leading periodic health checks - Build trust and a positive business relationship that ensure alliances with Karyopharm Therapeutics are kept on track to deliver value to both parties - Lead reviews with senior management to communicate key issues, milestones, and gather feedback - Proactively seek opportunities to extend business relationships by expanding existing partnerships or creating additional collaborations
Job ID
2020-1686
Job Locations US-MA-Newton
The Associate Director, PV Scientist leads the PV scientist group and supports the medical component of pharmacovigilance activities including surveillance activities providing scientific/clinical PV expertise with a focus on the identification, evaluation, and management of safety risks for Karyopharm products. This role will collaborate closely with the safety physician and cross-functional partners to evaluate and actively manage risks in accordance with global regulatory frameworks. - Mentor and support PV scientists in achieving departmental and organization goals - Hire, train and maintain well qualified PV scientists - Organize and perform independently or collaboratively as necessary, the relevant safety data analysis for Safety Management Team meeting; ensure adequate documentation of meeting minutes - Create and maintain an effective signal tracking process that fully documents signaling activities and can be used for regulatory inspection - Support other function teams for Karyopharm investigational products; serve as PV expert and liaise with Clinical Development, Clinical Operations, Biostatistics, Regulatory Affairs, and Contract Research Organizations and other entities as needed - Provide oversight for the safety data analysis and manage PV Scientists - Provide leadership in the development, implementation, and maintenance of robust procedures for the planning, preparation, and submission of high-quality safety reports - Contribute to health authority and other safety related query responses - Support study teams for Karyopharm investigational products; serve as PV expert and liaise with Clinical Operations, and clinical development - Demonstrate knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.) - Ensure compliance with Karyopharm and PVG & Risk Management policies and procedures - Prepares aggregate safety reports (e.g. DSURs, PSURs), including project management, safety database requests, understanding and writing the content, assimilating information from other groups, and quality checks - Plans and executes literature surveillance - Support PV activities as needed
Job ID
2020-1659
Job Locations US-MA-Newton
The Senior Quality Aduitor. The position will be responsible to assess compliance with , ICH and US FDA regulations and guidelines, and clinical study protocols. Responsibilities include performing audits; internal systems, and of clinical trial sites.This role participates in the development, implementation and maintenance of the corporate GCP Quality Management System and training program. This is a cross-functional position that works  in other departments, particularly Clinical Operations, in a collaborative nature as a QA on regulatory topics and interpretations. Strong communication skills , the ability to build internal and external relationships including interactions with clinical investigators and their staff concerning GCP matters, contract research organizations, and clinical laboratories.   - Control document lifecycle activities, including biennial review of procedures and document retention. - Performs verification and auditing of data generated during the conduct of a clinical study ensuring compliance with standard operating procedures and regulatory requirements - Assist with the development and implementation of a Clinical Quality Oversight program to include clear processes and procedures for executing appropriate quality support during clinical trials - Assist with providing FDA, EMA, and ICH guidance to support project teams in maintaining compliance and awareness in preparation for agency inspections - Develop audit schedules and conduct/coordinate global GCP audits including Part 11, Clinical and Pre-Clinical Data Management/Stats, clinical and non-clinical trial audits - Evaluation and review of clinical trial deviations to ensure appropriate investigation has been conducted, documented and corrective measures implemented to prevent future occurrences - Support coordination and management of GCP-related inspections by Regulatory Authorities, including pre-inspection activities and BIMO inspections. Participate in the preparation of responses to external regulatory inspections - Reveiw and approve clinical trial protocols and associated documentation (including, but not limited to Patient Information Letters, Informed Consent Documents, Patient Questionnaires, CRFs, etc.), as appropriate, to ensure compliance with relevant standards/regulations - Drive the implementation of integrated and comprehensive data-driven Quality Assurance activities, procedures and policies to ensure compliance with regulatory requirements and SOPs and to ensure a continued state of inspection readiness. - Summarize Quality activities, trends and areas of potential risk to Leadership and Clinical Team(s) - Actively participate and collaborate with Clinical Teams globally - Perform other duties as required.
Job ID
2020-1635
Job Locations US-MA-Newton
The Director/Senior Director, Quality GCP will be responsible for strategic and operational management of the GCP Quality group, in compliance with US (FDA) and International (ICH) regulations and Guidance, as to ensure that the appropriate processes, systems and activities are performed to protect the rights, safety and welfare of our clinical patients; to oversee, assess and directly work to continuously improve GCP quality processes; and support the state of GCP compliance at Karyopharm. Key expectations are for this role to lead in driving Karyopharm’s GCP and PV activities to meet the defined quality objectives, as well as to audit and assess the GCP and PV compliance status of our clinical sites, and to ensure that outsourced third parties (CROS and other GCP/PV service providers) are compliant and prepared for potential Sponsor and Regulatory Inspections.   - Develop and lead the GCP Quality organization at Karyopharm, managing, coaching and mentoring direct reports - Establish/implement clinical quality policies and procedures. - Provide quality oversight for all external clinical quality systems, including CROs, investigator sites, independent studies, central labs, non-clinical study laboratories and other key partners supporting Karyopharm’s clinical and pharmacovigilance programs. - Establish metrics for GCP and GLP vendor audit performance and compliance, and partner with the PV group in establishing metrics for internal and external PV operations. - Provide quality oversight of internal and external clinical functions. - Develop audit plans and perform audits of clinical, data management/processing, and pharmacovigilance vendors and activities. - Develop and optimize workflows with Clinical Operations to ensure clear paths of communication, responsibilities, and oversight. - Manage clinical site and vendor CAPA closure for audit observations, as per the SOP - Ensure operations in clinical development are compliant with cGCP, cGLP, FDA, ICH, EMA and industry standards - Review of clinical and data operational plans and protocols - Review of key safety, clinical and regulatory documents, such as DSUR, IB, IND and NDA - Provide support and contribute to other Quality Assurance activities, as necessary. - Provide consultation in interpretation of regulations/guidelines, as they apply to GCP practice, awareness of regional regulatory requirement, and phase of study/phase of manufacturing process. - Promote a culture of continuous improvement, and cross-functional problem-solving - Propose improvements to Quality Systems, in order to maintain compliance and improve efficiency - utilizing risk-based evaluations and tools. - Keep abreast of industry developments – forthcoming regulations, guidance, best practices, etc. - Serve as an SME for areas of responsibility during regulatory inspections, and directly manage inspection Ready -Room activities. - Support corporate and third-party inspection-readiness activities.
Job ID
2020-1632
Job Locations US-MA-Newton | US-Remote | US-NY | US-NJ | US-NC | US-DC | US-FL | US-GA | US-IL | US-TX | US-CO | ...
Reporting to the Chief Commercial Officer, this role will be responsible for driving innovation across the Commercial organization by partnering internally across field-based, local and functional teams as well as with external stakeholders.  The Senior Director, Commercial Innovation will lead the development & execution of an experimentation framework driving innovation & agile optimization for the brands as well as infusing a test & learn culture across the organization.  - Enhance the commercial value offering, including but not limited to digital innovation, enhanced HCP engagement strategy, patient value, and value-based care - Identify opportunities with strong potential for commercial and/or patient value creation, and design and execute pilots to strategically disrupt the market and differentiate Karyopharm offerings - Drive new ways of doing things and experimentation to drive growth against new targets, sales channels and customer segments - Lead a test-and-learn approach to commercial innovation, including rapid prototyping, testing, designing and scaling leading-edge customer experiences - Set the innovation agenda and assist the CCO to define innovation priorities - Provide deep knowledge and expertise on the competitive global market and customer engagement trends to commercial and other functional partners - Develop an assessment framework for pilots to evaluate impact and predict future success - Facilitate workshops and discussions to generate, evaluate and prioritize ideas and scope innovation projects, in order to establish clear priorities for maximum business throughput - Monitor pilots against expectations and make recommendations to kill early, improve or scale - Develop business cases and, working closely with cross-functional partners, implement plans to scale pilots and embed into existing commercial team
Job ID
2020-1619
Job Locations US-MA-Newton
We are seeking a Director / Sr. Director, Engagement & Awareness to serve as the leader of a small team that will focus on innovative ways to drive awareness of Karyopharm Therapeutics, our innovative science and our FDA approved drug, XPOVIO (selinexor), for our non-commercial stakeholders.  This role will focus on building awareness and bridging relationships across broad communities, including patients, advocates, physicians and other healthcare providers, biotech and pharmaceutical industry partners, elected officials, academia, media, the employment market, and other stakeholders who may intersect with Karyopharm.  Campaigns and projects will include a focus on social media, advocacy groups, and other traditional and nontraditional channels to create awareness for Karyopharm, our science and selinexor to a broader community. This role will report into the Chief People & Corporate Engagement Officer.    - In adherence with Company strategic direction, drive global external communications strategy and execution for selinexor and our other assets, focused on raising awareness and our mission among relevant stakeholders, improving understanding of our innovative technology and increasing positive coverage related to the company, science and programs. - Manage the identified engagement programs and execute on the cross-functional tactical responsibilities within the organization to achieve strategic goals. - Support strategic priorities and initiatives to help manage messaging across Karyopharm’s external digital and social media channels. - Partner with relevant stakeholders to create, develop and synthesize a consistent narrative and messaging plan across the organization related to how Karyopharm communicates with the oncology community including patients, advocates, physicians and other healthcare providers, biotech and pharmaceutical industry partners, media and other stakeholders. - Support and execute on the Company strategy regarding communication with the media community, predominantly in the US, to shape educated and balanced media coverage for Karyopharm, our science and our programs. - Support and align with disease awareness and patient-led campaigns (internal and external) for Karyopharm, in partnership with medical affairs. - Manage a team of employees by utilizing best in class managerial approaches and modeling leadership competencies such as effective communication, managing execution, coaching & development, and engaging/inspiring.    
Job ID
2020-1615
Job Locations US-MA-Newton
We are seeking a Senior Director, Launch Excellence to serve as the lead for launch activities across the organization. This position will define and manage rigorous cross-functional processes and plans that enable Karyopharm to execute on critical product launches and company initiatives. In this highly visible role, you will partner with colleagues in R&D, Clinical, Marketing, Market Insights, Market Access, Sales, Finance, Legal, Regulatory, Supply Chain, Medical Affairs and other teams to program-manage launches, strategic campaigns, sales enablement initiatives, and other programs. This position will create the Launch Center of Excellence for driving planning, execution, communication, tracking & measurement, and collaborations across the company.    - Lead the launch strategy initiatives, responsible for delivering the launch plans and preparing the organization to commercialize our products. - Continually raise the bar across Karyopharm to make each launch better than the last. - Benchmark biopharma and outside of pharma trends on launch best practices around preparation and execution.  Bring cutting edge approaches into Karyopharm. - Collaborate with colleagues to define detailed launch plans and lead cross-functional meetings, project tracking, and communications in support of launches; identify and escalate any issues to quickly solve - Manage the planning, execution, , including timelines and deliverables – you will supercharge our outcomes by enhancing our internal communication and collaboration to ensure no details are missed - Be a champion for Launch Readiness across the company. Energize and excite the organization on the importance of launch readiness and what we can achieve - Define, track, and communicate dashboards and other tracking tools to ensure visibility and focus on performance against launch goals, and facilitate closed-loop improvement; you will champion a results orientation throughout the organization - Identify and manage risks and dependencies, including the development of contingency plans; your proactive approach will help us navigate uncertainty and hit key goals - Continually seek and act on opportunities to improve cross-functional collaboration and efficiency; your insights and initiative will amplify results - Identify & communicate evolving needs from benchmarking and post-mortem activities to ensure continual process improvement. - Collaborate extensively across functions (i.e. clinical, market planning, market access, regulatory, patient advocacy and finance) and with the executive leadership team to provide key insights and shape launch strategy. - Provides cross functional leadership for launch strategy, including priorities, milestones, and key performance indicators (KPIs) and milestone monitoring. - Ensure alignment and continuity between pre-commercial launch activities, commercial launch activities and post-launch activities. - Effectively manage assigned budgets and applicable launch agencies, vendors, etc.
Job ID
2020-1614