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 | US-FL
As a member of the field-based medical affairs team, the Community Oncology Liaison (COL) 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
2020-1679
Job Locations US-VA | US-NC | US-SC | US-GA
As a member of the field-based medical affairs team, the Community Oncology Liaison (COL) 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
2020-1678
Job Locations US | US-MA
As a member of the field-based medical affairs team, the Community Oncology Liaison (COL) 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
2020-1676
Job Locations US-NY-Manhattan
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
2020-1675
Job Locations US-OH-Columbus
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
2020-1674
Job Locations US-CA-South Los Angeles
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
2020-1670
Job Locations US-MA-Newton
The Compensation Manager is responsible for implementing, managing and continuously improving our compensation programs - supporting our managers and employees.  The individual responsible will oversee the day-to-day analysis, execution, and of global broad-based pay and rewards program. The successful candidate will report to the Senior Director Total Rewards & HR Operations.  In addition, he/she will benchmark competitive practices, recommend actions, and ensure plans remain compliant with required regulations.  In addition, the individual will be required to assist in the administration of benefits programs as necessary ensuring synergy with HR Operations, Benefits, and HRIS. A key measure of success in this role will be the ability to embrace employee engagement with a focus on the delivery of the programs and services the company offers to employees.  Along with this will be the openness and eagerness to participate cross-functionally in cultural initiatives aimed at increased efficiency and alignment. - Ensure the competitive position of compensation programs through job evaluation, benchmarking, participation in market data surveys, maintaining relationships with third party consultants, and partnering with talent acquisition - Perform comprehensive analysis and make recommendations on salary/wage management, structure design, and pay equity - Participate in the annual merit, bonus, and equity award processes across markets - Identify training, operational needs, and opportunities to build organizational change capabilities and enhance the employee experience; Capture business requirements, lead global initiatives, and update compensation programs and procedures to align with human capital priorities - Maximize vendor relationships and administer equity awards in accordance with the terms and conditions of the awards, governing plan documents, and internal processes and procedures - Collaborate with Senior Director, Total Rewards, Accounting, and Legal team in Compensation matters including the company’s equity program - Partner with HRIS to develop and design systems solutions to optimize enterprise-wide job architecture, administration of the annual merit and equity cycle, corporate short-term incentive plan, and additional business area specific incentive plans - Provide interpretation of and ensure compliance with federal and state legal requirements and other country specific regulations - Researches and proposes competitive base and incentive pay programs to ensure the organization attracts and retains top talent. - Performs analysis utilized to guide leadership on policy and guideline interpretation, pay decisions and job evaluations. - Develops compensation programs that are in alignment with our company strategies and monitors those programs against industry trends. - Drives annual review, preparation and administration of the organization’s compensation program - Selects and participates in relevant compensation surveys - Ensures our compensation practices continue to be in compliance with all government regulations - Serve as liaison among Human Resources, Benefits, Recruitment, and Payroll areas with regard to operations and the HRIS - Constantly seeks to leverage HR technology to advance processes that maximize efficiency and accuracy and minimize exposure - Partner with the Benefits Manager in the administration of benefits programs as needed    
Job ID
2020-1664
Job Locations US-Remote | US-MA-Newton
The Associate Director, Market Access Marketing, coordinates the overall development and implementation of brand value propositions, access strategy and payer tactics, aligning operations to ensure patients have affordable access to XPOVIO.  Primary focus is on US Payers (Health Plans, PBMs, IDNs), Pathway organizations, GPOs, Strategic Accounts, and SPs as well and other market access influencers. This individual will train the Corporate Account Director teams on PART approved resources and programs and will lead the market research efforts on landscape and resource/program testing.  This individual will develop a deep understanding of overall market access customer needs and develop appropriate optimal personal and non-personal deliverables to be utilized by the Corporate Account Director teams.   The Associate Director is a disciplined risk-taker comfortable in an entrepreneurial environment with the resource constraints of a young commercial organization. The ideal candidate is creative, flexible, and adaptable to new and changing situations. This individual must be goal-oriented, know how to “roll up their sleeves” as well as manage outside consultants and vendors to get things done. This position reports to the Senior Director, Corporate Accounts: Payers.    - Contribute to the development of the overall market access strategy and tactics - Ensure product and market access strategies and tactics are developed for each indication while supporting integrated product and indication launch brand planning and tactical development for overall portfolio - Work closely with the commercial leadership team to implement overall strategy, objectives and  key performance indicators for Market Access deliverables - Partner closely with Patient Services and Corporate Account Directors to execute strategies and tactics to effectively engage payers and other strategic accounts - In collaboration with Marketing, Corporate Account Directors, and other stakeholders, develop effective and efficient resources and programs to deliver meaningful, believable, and actionable deliverables to Corporate Account Director team for use with Market Access customers - Gain PART approval for Market Access resources and programs and train Corporate Account Director team on those deliverables - Attend and support scientific and industry medical meetings, preparing planned post-meeting deliverables - Partner with cross-functional teams to conduct highly innovative research/analytics to define brand-level market access strategies and tactics - Provide competitive intelligence regarding Market Access landscape to inform strategic and tactical development and positioning - Contribute to the development of metrics for payer and reimbursement strategies, markets, and channels - Collaborate with multiple stakeholders to identify and remove payer/access barriers and support access - Lead development of pricing and reimbursement strategies; managing price policies for reimbursed Karyopharm product(s) - Support development of pricing estimates and market access assumptions for pipeline product(s) or in-licensing opportunities at various stages of clinical development - Manage Market Access agency and other Market Access vendors along with managing affiliated budgets      
Job ID
2020-1658
Job Locations US-NY | US-NJ
The Medical Science Liaison (MSL) is responsible for the identification and engagement of a targeted group of national and regional thought leaders/healthcare professionals (HCPs), as well as payers and managed care accounts. This position provides consistent delivery of educational and compliant scientific information in support of Karyopharm’s pipeline.   - Identify and develop relationships with community/academic thought leaders along with treatment advocates on a local, regional, and national level. - Serve as Karyopharm’s scientific representative to the medical community and facilitate the appropriate exchange of scientific information. - Provide clinical and economic value information to payers and formulary decision makers. - Utilize approved resources to address customer needs, ensuring they are in compliance with all guidelines and regulations. - In partnership with clinical operations, 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. - Communicate therapeutic market trends which may impact Karyopharm’s pipeline. - Participate and support advisory boards and steering committees. - Lead and/or participate on committee/project teams which support MSL strategies as delegated by MSL leadership - Gain feedback through field interactions with HCPs to uncover collaboration opportunities and pair customer’s unmet needs with available internal resources. - The candidate will assume a leadership role by teaching, coaching and mentoring new hires and/or less experienced MSLs and by assuming responsibility for special projects as they arise.
Job ID
2020-1651
Job Locations US-MA-Newton
Reporting to the CCO, the Senior Vice President of Marketing will be responsible for leading the Marketing organization in the development of the marketing strategy, and the planning and execution of tactics to optimize the adoption and use of XPOVIO in the US.  The near-term focus is on maximizing the Mar 2021 launch of XPOVIO in earlier line multiple myeloma. The SVP will also be responsible for developing the marketing strategy for additional indications in hematological malignancies and solid tumors. The SVP will manage groups responsible for product management for multiple in-line indications, new product planning and marketing operations. The person will also be responsible for assuring launch readiness across Marketing and the Commercial organization as a whole.  This leadership role is responsible for: marketing to all external customers, leading agency and vendor relationships, establishing KOL relationships and leading cross functional collaboration internally and externally.  The SVP will work closely with a breadth of Karyopharm functional groups, including but not limited to Sales, Market Access, Regulatory Affairs, Legal, Medical Affairs, as well as business partners to ensure organizational alignment with the commercialization strategy of XPOVIO.  In this leadership position, this executive will help establish commercial and corporate goals, and to advocate for the required budget and resources from the executive team and board of directors. - Hire, coach, develop, and retain staff members. Create compelling and robust development and succession plans for all key positions within the function. - Continue the development of the marketing team members including product management, marketing operations and new product planning. - Inspire, align, mentor, motivate and mobilize teams. - Lead, develop and execute the XPOVIO marketing strategy including identification of key market issues, critical success factors for the brand, design of solutions, brand vision, positioning and messaging including competitive strategies and marketing tactics.  - Drive innovation in strategy and tactics to build brand awareness, excitement and intent to prescribe. - Build incremental capabilities in Marketing to drive success and position Karyopharm as a leader in Marketing. - Work across all Commercial functions to establish performance targets and measurement plans. - Oversee and deliver on the execution of compliant US brand marketing plans and programs, including developing and managing the marketing budgets, developing and refining department procedures (SOPs) with Marketing Operations; and managing, mentoring and developing organizational resources. - Identify and align on market research needs, and plans with Commercial Analytics, and translate competitive intelligence insights into product strategies and forecasting assumptions.  - Work collaboratively with key thought leaders, academic institutions, cooperative groups, and professional and patient advocacy groups to validate commercial approach and secure launch readiness for additional indications in the US. - Work with agency of record, strategic consultants, and other vendors as necessary to develop launch programming and ensure superior execution of tactics. - Provide input on payer/pricing strategies through product life cycle. - Monitor and manage brand marketing budgets and forecasts, while evaluating cost effectiveness and ROI of activities and results. - Demonstrate company values on a consistent basis.  Acts, and is accountable for others in his/her team to act, in compliance with all laws, regulations and policies.  
Job ID
2020-1645
Job Locations US-MA-Newton
- Provide project management / coordination of department support to Global Medical and Scientific Affairs - Assist in the development of strategic and tactical department asks - Work cross-functionally with necessary department stakeholders to ensure on-time completion - Create project planning, manage timelines and manage meetings - Management of the pre-Independent Research Review Committee as well as Independent Research Review Committee, in conjunction with assigned Global Medical Research and Medical Science Liaisons, Medical Affairs Disease Leads, Clinical Research and Development, Translational, etc. - Work closely with GMSA leadership team to enable delivery of key action items - Create and manage meeting agendas and minutes - Collaborate or lead cross-functional teams for assigned projects / tasks - Identify ways to optimize processesCoordinate agreements process needs and tracking for final execution - Coordiante creation of purchase orders, track invoices and respective reporting - Report to Director of GMSA Operations
Job ID
2020-1641
Job Locations US-MA-Newton
The Senior Vice President, Head of Business Development is responsible for setting the partnering and business strategy for the development and commercialization of all company assets, with a particular focus on the company’s ex-US business strategy.  This role will work closely with the commercial team to execute a strategy for global commercialization of XPOVIO, manage existing and future alliances, and focus on strategy and execution for pipeline expansion. - Develop, manage and oversee the execution of Karyopharm’s Business Development Strategy - Focus on global development and commercial opportunities for Karyopharm’s assets with both strategic alignment at the highest levels of the organization and tactical execution to grow and maximize enterprise value - Facilitate the on-going development of our partnership strategy & manage the overall partner program with broad cross-function collaboration - Manage the overall partner strategy supporting our product portfolio needs:  Establish input and feedback channels to gather needs and priorities from various functions and the leadership team, while also adding your own view of opportunitie, Provide frequent updates on partnership development to management - Develop and manage SWOT analysis on partnerships relative to major competitors - Lead new partner deals - Proactively source and evaluate partner candidates to meet our identified business needs - Convincingly paint the picture of potential partnership value - Respond to partner inquiries in a time-efficient way corresponding to our priorities, while upholding Karyopharm’s reputation in the market - Negotiate business terms and handle contracting - Spot New Innovation opportunities as they arise. - While not a primary focus of the role, the person is well-positioned to identify potential new solutions that marry the capabilities or data from other companies with the solutions from Karyopharm to launch new combined capabilities - Develop and present executive presentations in full alignment with executive direction and consensus; develop, present, and manage detailed project/enactment plan for opportunities deemed of interest to the company. - Provide periodic detailed and executive level updates to multiple audiences on Business Development activities to ensure awareness and alignment across the organization.
Job ID
2020-1640
Job Locations US-MA-Newton
- Foster an environment for a legal function that adds strategic value to the organization by proactively implementing business-oriented solutions within the framework of the company’s risk tolerance profile; - Serve as trusted advisor and confidant to Karyopharm’s Board of Directors, Chief Executive Officer and President/Chief Scientific Officer; - Lead all legal activities, including corporate law, SEC filings and compliance, capital markets and financial transactions, business partnerships and other strategic collaborations, litigation, contracts, including clinical trial agreements, corporate governance, employment and human resources activities and general legal support of all other business activities; - Manage multiple direct reports to provide exceptional subject matter expertise across the sales, G&A and R&D functions; - Manage a diverse set of external counsel; - Provide legal support regarding business development transactions, including mergers, acquisitions, divestitures, licensing and collaborations. This includes support of due diligence, transaction negotiation and drafting, and ongoing post-closing legal support, as needed; - Support commercial activities and FDA/other regulatory body compliance; - Support the commercial organization and investor relations/public relations teams by providing legal oversight in all external communications; - Provide company-wide guidance on all Karyopharm business activities; - Support operational activities for parent and subsidiary companies, including intercompany transactions, and compliance with local regulations, - Acts as Corporate Secretary for all matters, including Board of Directors and committee meetings as well as providing thorough and thoughtful feedback to the Board.
Job ID
2020-1639
Job Locations US-MA-Newton | US-Remote
We are seeking a talented individual to join our team as the XPOVIO PM / Sr. PM responsible for Patient Marketing.  The selected individual will be responsible for the development, execution, and management of several key marketing programs critical to the success of the XPOVIO brand. This individual will serve as an integral member of the marketing team, and will work closely with Field Sales, Sales Training, Medical Affairs, Legal, and Regulatory to develop, execute and measure ROI of patient tactics.  This position requires a highly motivated individual who can work effectively in a dynamic environment with a high degree of flexibility and creative problem solving.  This position will report to the Brand Lead of XPOVIO U.S. Marketing and will be based in Newton, MA. - Initiate, lead, and drive marketing work projects/tactics/resources, including direction and day-to-day management of agencies of record and additional vendors as needed - Work closely with Brand Lead to align on strategy and execution - Maintain and refine existing, and lead the development of new patient marketing tactics, programs and initiatives - Ensure project timelines are met - Attend review committee meetings to represent new and existing resources, and effectively manage annual renewals / expirations - Manage SOWs, POs and marketing budget / monthly accruals to a high degree of accuracy - Work closely with the U.S. sales force to adapt strategies, tools, training and messages to drive success for U.S. business         - Participate in several brand critical initiatives such as but not limited to, brand planning, market research, and message & creative evolution - Ensure that all marketing processes, documents and tactics are developed and implemented in accordance with Karyopharm corporate compliance guidelines   -  
Job ID
2020-1638
Job Locations US-MA-Newton
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
2020-1636
Job Locations US-MA-Newton
The Senior Quality Aduitor/Manager of GCP Quality. 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.   Essential Duties And Responsibilities - 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 Vendor Management Specialist reports to the Associate Director, Vendor and Contracts Management. The Vendor Management team is responsible for implementing the procurement, oversight and vendor management plan to successfully manage relationships with vendors who provide R&D services to Karyopharm. The successful candidate will utilize Karyopharm’s ICURE values collaborating with various levels and functions throughout and across Karyopharm. - Assist with the maintenance of vendor trackers and master lists, working closely with internal stakeholders to assure proper vendor qualification - Help with implementation and validation of new Vendor Management System - Be responsible for a group of vendors, their onboarding, oversight, governance and relationship maintenance - Help track escalations and work on resolutions with vendors and internal stakeholders - Identify opportunities for implementation of cost savings - Support the negotiation of business terms and help create a standard RFP for functional teams - Support FMV costs analysis for different types of services - Help identify new and potential vendors that could work in line with ICURE values. - Coordinate meetings with potential vendors and be able to present to them about Karyopharm ICURE values and outsourcing needs - Provide support for team projects 
Job ID
2020-1634
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
The CPM/Sr CPM is responsible for the planning, implementation, execution, and management of one or more clinical research studies.  She/he manages clinical outsourcing to CROs and other vendors such as labs, IRBs, etc. She/he may author, review and approve various study related documents and plans. She/he evaluates issues, interprets data, and suggests and implements solutions and mitigation as required. She/he is responsible for the financial management of a study/program and develops and oversees study timelines. - Represents and leads the study team to design, develop, execute, and deliver the clinical study in accordance with the clinical development plan/strategy and timelines - Authors/ reviews/ contributes to clinical study documents - Reviews and approves study related plans generated by Clinical CROs and vendors - Provides input as the subject matter expert for the study during regulatory inspections - Executes the clinical study in accordance with the project clinical development strategy and timelines - Accountable for the timely clinical review and/or approval of Case Report Forms, User Acceptance Testing (UAT), and provides clinical input into corresponding completion guidelines - Responsible for oversight of identification and selection of investigator sites - Responsible for planning and conducting investigator’s meetings in cooperation with the respective departments - Ensure the delivery of clinical trial supplies in collaboration with the clinical supply team - Collaborates with the cross functional team on selection and management of clinical vendors - Manages escalation of study related issues and communicates as appropriate with management and other R&D functions - Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight - Trains and manages CRO and other clinical vendor activities to ensure the quality meets Karyopharm and regulatory requirements - Monitors the status of clinical data collection of assigned clinical studies - May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance - Monitors progress of clinical activity and produces regular and ad hoc reports and presentations as required - Evaluate site and study performance metrics against agreed upon budget, deliverables and timelines - Oversees and monitors the management of clinical studies ensuring they are conducted in accordance with the approved study plans through regular investigator site / CRO / clinical vendor contact - Responsible for the availability and tracking all relevant study information/ study metrics - Oversees the resolution of data quality issues - Reviews correspondence and monitoring reports relating to the study - Evaluates CRO and vendor performance for future work - Provides periodic status reports regarding study timelines, accruals, etc. to Karyopharm Management as requested - Reviews budgets and contracts with CROs, vendors, and investigative sites, as applicable - Requests and critically evaluates proposals and change orders from CROs and vendors - Leads team through selection process and provides input into contracts, change orders, and/or work orders. Maintains knowledge of therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities - Supports department initiatives and process improvements. - May mentor other Clinical Operations staff (e.g. CTAs, CTM, etc) - Attend relevant symposia, conferences and scientific meetings, as necessary - Provide support and potential identification of training needs across Clinical Operations and may support the creation, development and potentially provide training support to meet those needs. This includes any lessons learned sharing across the project team members - May directly manage or line manage other clinical operations staff members - Up to 20% domestic and/or international travel may be required
Job ID
2020-1631
Job Locations US-MA-Newton | US-Remote
We are seeking a talented individual to join our team as the XPOVIO Hematology Product Manager / Sr. Product Manager responsible for Healthcare Professional (HCP)Marketing.  The selected individual will be responsible for the development, execution, and management of several key marketing programs critical to the success of the XPOVIO brand.  This individual will serve as an integral member of the marketing team, and will work closely with Field Sales, Sales Training, Medical Affairs, Legal, and Regulatory to develop, execute and measure ROI of HCP tactics.  This position requires a highly motivated individual who can work effectively in a dynamic environment with a high degree of flexibility and creative problem solving.  This position will report to the Brand Lead of XPOVIO U.S. Marketing and will be based in Newton, MA.  - Work closely with Brand Lead to align on strategy and execution - Initiate, lead, and drive marketing work projects/tactics/resources, including direction and day-to-day management of agencies of record and additional vendors as needed - Maintain and refine existing, and lead the development of new HCP, patient and market access personal and non-personal marketing tactics, programs and initiatives - Ensure project timelines are met - Attend review committee meetings to represent new and existing resources, and effectively manage annual renewals / expirations - Manage SOWs, POs and marketing budget / monthly accruals to a high degree of accuracy - Work closely with the internal business partners to adapt strategies, tools, training and messages to drive success for U.S. business         - Participate in several brand critical initiatives such as but not limited to, brand planning, market research, and message & creative evolution - Ensure that all marketing processes, documents and tactics are developed and implemented in accordance with Karyopharm corporate compliance guidelines  
Job ID
2020-1630