Karyopharm Therapeutics Inc.

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Thank you for exploring career opportunities at Karyopharm! Please click on the job title for more information, and apply from that page if you are interested.

 

Karyopharm Therapeutics Inc. (the "Company") is an equal opportunity employer.  All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law.  Consistent with its obligations under applicable law, the Company will make reasonable accommodations for qualified individuals with disabilities.  If you require an accommodation in the application process, please contact a member of the Company’s Human Resources department. 

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Job Locations US-MA-Newton
SUMMARY: Karyopharm Therapeutics is actively seeking a Vice-President Regulatory Affairs to join our rapidly growing organization in Newton, Ma.  The incumbent will lead the company’s global regulatory strategy and ensure compliance with GXP requirements. The ideal candidate will be a strategist with the capability to be immersed in running the day to day operation of the department. Additionally, must have the skills and experience to meet the challenges, responsibilities and rewards that come from working in a high energy, fast paced environment. RESPONSIBILITIES: - Provides guidance and leadership to the members of the regulatory affairs teams. - Directing, controlling and implementing all regulatory activities according to in-house Standard Operating Procedures as well as FDA and ICH requirements - Develops short and long range global regulatory plans and strategies that support Karyopharm’s investigational and to-be marketed products - Supports product development plans and in/out licensing and partnership opportunities. - Develop and implement strategies for the timely preparation and execution of submissions to regulatory authorities for all phases of the product life cycle. - Provide expert analysis and evaluation of regulatory information. Informs the executive team (and external stakeholders, as needed) of the regulatory status of products and significant regulatory issues. - Analyze and make recommendations for improving internal and vendor compliance with the FDA and international regulatory authorities as well as ICH quality regulations and guidelines. - Provides analysis of regulatory guidance documents, regulations or directives that influence Karyopharm’s products and operations. Advises personnel in other departments regarding their applicability and impact. - Communicate with US and other international regulatory agencies; ensures the company is compliant with US and international regulatory requirements - Develop and maintain current regulatory knowledge and ensure that staff is aware of new and existing relevant procedures - Prepare/oversee the preparation of meeting requests, briefing documents, coordinate and prepare team for meetings, and interface with regulatory authorities, be primary liaison with regulatory authorities for day-to-day interactions. - Coordinate and prepare responses to requests for information from regulatory authorities - Develop and manage a global budget supporting regulatory department - Hire, mentor, and support the personal and professional development of regulatory staff
Job ID
2020-1549
Job Locations US-MA-Newton
- Responsible for drafting, reviewing and negotiating vendor agreements, healthcare professional and other consulting agreements and pre-clinical contracts. - Legal lead on Investigator Sponsored Trial (IST) program, responsible for drafting and reviewing IST agreements and related amendments and attending team calls with the GMSA IST program leads. - Legal lead on Grants and Sponsorship Letters and escalation point for all revisions requiring Legal review. - Responsible for handling any escalations from the Vendor Contracts Specialist and Contracts Manager and determining if further escalation is required for finalization of contracts. - Work with other internal departments as appropriate for activities related to contracts (i.e. quarterly finance review and quarterly related party review). - Provide continuing support on executed vendor and consulting agreements (e.g., drafting amendments, extensions and terminations, interpreting contractual language in response to issues or questions that arise). - Follow internal company processes related to contract management systems and department processes; ensure that contract management systems related to vendor contracts are current and accurate; offer and contribute to existing or new department process guidelines to ensure consistencies and improvement. - Overall support for the vendor contracts team and oversight of all activities to ensure that the team is responding to requests both appropriately and in a timely manner. - Support of special projects as assigned by General Counsel or Associate General Counsel.
Job ID
2020-1548
Job Locations US-MA-Newton
SUMMARY: Provide strategic oversight of operational activities in support of monitoring the safety profiles of products. Work in close collaboration with Pharmacovigilance team to develop and implement philosophies and policies that support best practices in pharmacovigilance and ensure compliance with FDA and international regulations and guidance, ICH guidelines, and corporate policies. RESPONSIBILITIES: - Accountable for day to day operational performance - Strategic oversight to a team of safety professionals responsible for PV Operations - Guide implementation of pharmacovigilance process improvement opportunities via SOPs, work practices and training - Work with internal and external colleagues including vendor management, data reconciliation, data management, and clinical operations - Assist in internal audits and regulatory inspections
Job ID
2020-1547
Job Locations IL-Tel Aviv
  Oversees the progress of clinical investigations by conducting qualification, initiation, interim and close out visits to sites.  Responsible for maintaining study documents. Monitors clinical trials in accordance with Good Clinical Practices. Performs site oversight to ensure patients wellbeing is being kept. Tracks study progress and ensures adherence to ICH-GCP, applicable regulations, standard operations procedures and study protocol.  Works closely with the Clinical Trial Managers and Clinical Project Managers to ensure all monitoring activities are conducted according to study requirements. RESPONSIBILITIES: - Participates in the investigator identification process. Performs initial feasibility and qualification visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study - May assist in the preparation and review of protocols, eCRFs - Develops or contributes to the development of study manuals, study plans, study related forms and monitoring tools - May assist with the preparation, review and submission of relevant regulatory documents to the appropriate Regulatory Authorities and IRB/IECs - Collects and reviews regulatory documents received from clinical sites throughout the course of a study, to ensure all required documents are obtained, complete and in compliance with ICH-GCP and local regulations - Coordinates, prepares and conducts study initiation visits - Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures, local regulations, ICH-GCP and SOPs, through on-site monitoring visits - Ensures data entry and query resolution are completed in timely manner, by remotely reviewing of CRFs, contacting the sites, providing guidance, answering questions, and facilitating resolutions on an ongoing basis - Performs investigational product (IP) accountability. Verifies the integrity of the IP on -site, destruction of unused materials or ensures return to designated location, as required - Assures the rights and wellbeing of the study patients are maintained - Oversees the study progress at the clinical sites; identifies potential risks and provides sites with training as required throughout the course of the study - Takes part in the generation of recruitment plans. Works with the site to increase enrollment. Plays key role in identifying obstacles for patient recruitment and retention and contribute to patient enrollment enhancement plan generation and implementation - Maintains Investigator Site Files and Trial Master File for the duration of the study, ensuring essential documents are filed appropriately, and assisting in the file review and reconciliation process in preparation for audits and archiving - Prepares monitoring reports and letters in a timely manner in accordance with the study monitoring plan - Contributes to the review and approval of other CRAs’ monitoring reports. Discusses with the relevant CRA issues of concern and escalates per need - Serves as primary contact between Karyopharm and investigator; coordinates documents and files all correspondence - Maintains and updates project-related data in CTMS - Participates in study team meetings providing progress/status reports and monitoring updates, on a site level - Assists with, attends, and may present at CRA training meetings and Investigator Meetings for assigned studies - Performs study close-out visits - Prepares sites for audit by sponsor or inspections by FDA or other Competent Authorities; participates in internal audit preparation; assists with audit responses - Potentially assists in training and mentoring fellow CRAs - Performs other study related duties as requested - Up to 75% domestic and/or international travel may be required
Job ID
2020-1544
Job Locations US-MA-Newton
- Review source documentation for adverse events (AEs) and safety-related special situations reported to Karyopharm from spontaneous sources, market research, Company-sponsored and investigator-sponsored trials, and compassionate use - Upload source documents to ARGUS safety database, triage ICSRs, and assess regulatory reporting timelines - Write ICSR narratives for applicable reports - Perform peer quality reviews for data entry and ICSR narratives within ARGUS - Collaborate with PV MD for collating ICSR queries as applicable per ICSR case - Write and send ICSR queries to post marketing call center, Investigative sites, CRAs, and CTM’s utilizing Query templates and Query Activity tracking within ARGUS - Manage open cases to closure - Assist with Sponsored trial SAE reconciliation with DM as needed; collaborate with investigator-sponsors and vendors to complete AE reconciliation - Assist with the management of ICSR source document intake from the Pharmacovigilance Inbox, confirming receipt of ICSRs with applicable reporters - Support PV MD and clinical study teams as needed
Job ID
2020-1543
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
2020-1542
Job Locations US-MA-Newton
Senior Manager, GCP Compliance will be a critical team member who contributes to implementation of risk-based GCP and compliance oversight. This person will be responsible for the planning, identification, coordination, execution, reporting and closure of CGP Compliance issues in support of clinical programs. The incumbent is also responsible for supporting the GCP auditing plan and assisting its management.   - Conduct Regulatory Submission Review such as Investigator Brochures (IB), Development Safety Update Report (DSUR), Clinical Study Reports (CSRs), NDAs, Clinical Protocols, ICFs. - Conduct/Lead Internal System, process and documentation Audits to ensure compliance to the Code of Federal Regulations, the International Conference of Harmonization (ICH), applicable regulations and company SOPs. - Conduct qualification or routine vendor audits of Clinical Research Organizations, Clinical Laboratories, Phase I Units, Imaging Vendors, eTMF Vendors, Investigator Sponsored Trials - Assist in the management and closure of GCP CAPAs, including metrics tracking and reporting. - Participate in QA Review of Internal SOPs, driving toward establishing and maintaining harmonized and cross-functional SOPs. - Perform training and education internally in global GCP standards, and externally as required (Investigator Meetings, CRA Trainings, Pre-Approval Inspections, etc.) - Represent GCP QA in assigned weekly protocol project team meetings. - Assist with the preparation and hosting activities during regulatory inspections and investigations conducted by various regulatory authorities, including the coordination of timely responses. - Support Clinical QA projects.
Job ID
2020-1541
Job Locations US-WA | US-Remote
The Karyopharm Nurse Liaison role is a field-based position comprised of nurses reporting to the Director, Clinical Nurse Educators. The KNL partners with their commercial team members, sales, marketing, managed markets, patient advocacy, as well as medical counterparts, and medical affairs.  The KNL will be responsible for establishing strategic relationships with key customers, local and regional advocacy organizations and the oncology nursing community.  This collaborative approach will serve to provide education, enhanced clinical care, and the opportunity to build strategic relationships with both key customers and Karyopharm internal customers.  The KNL educates and trains clinical personnel in the delivery of therapies, patient treatment management, and related clinical topics in support of the Karyopharm field sales team.   - Represent specified Karyopharm Therapeutics products in the medical community for an assigned geographical area in accordance with Karyopharm’s direction and policy, focused on the nursing segment - Deliver approved product and disease state-related education to healthcare professionals (HCPs) within assigned geographic region - Develop strong long-term relationships with clinical personnel, advanced practice provider opinion leaders, key nurse opinion leaders, advocacy organizations, key nursing organizations, and societies focused on the nursing segment - Work cross-functionally as part of an integrated team to identify and access key customers, assess their education needs, and provide clinical and educational support - Collaborate with Karyopharm counterparts to identify and access key customers. Communicate and coordinate KNL efforts with Regional Business Directors, Hematology-Oncology Specialists, Patient Advocacy, Market Access, and other corporate colleagues as part of an integrated team following all compliance and regulatory guidelines, to ensure customer needs are addressed - Develop and execute geographical-based strategic and tactical plans to meet customer and business needs - Work closely with marketing to identify and develop nursing specific tools to fulfill the needs of the customer - Executes external disease state educational presentations and on label product presentations for dinner programs, round tables, and society presentations. Provide in-office/in-hospital educational presentations to key customers reactively in response to an identified need/request for clinical information.  Additional presentations for nursing groups, societies, and various patient support groups, including patients and caregivers, on disease state and Karyopharm Therapeutics marketed products, utilizing on label approved slide decks may also be completed by the KNL. - Identify and communicate field issues, opportunities and compelling activities through appropriate organizational venues - Partner with key commercial and medical personnel to ensure appropriate and compliant utilization of product and disease state education and resources - Maintain an open dialogue with key opinion leaders in the nursing arena and develop product champions for promoted projects - Perform all administrative functions of the position in a timely and efficient manner and in accordance with Karyopharm Therapeutics policies and procedures
Job ID
2020-1540
Job Locations US-MA-Newton
Summary The Manager, Business Development & Alliances will support the execution of global partnering activities at Karyopharm Therapeutics. The Manager is also responsible for ensuring that major operational partnerships are proactively and effectively managed. The Manager will develop excellent relationships internally and externally in order to support and drive business development and alliance activities. - Manage current and future industry partners by tracking progress of commercial/development activities along with contractual obligations (eg: milestone payments) - Build trust and a positive business relationship that ensure alliances with Karyopharm Therapeutics are kept on track to deliver value to both parties - Prepare presentations and internal communication for internal processes related to BD activities. - Coordinate development and commercialization strategy with Karyopharm alliance partners along with tactical execution - Participate in dispute resolution, engaging appropriate internal and partner decisionmakers - Manage joint meetings with partner organizations; includes Joint Operating Committee and functional sub-teams - Support the evaluation and recommendation of business development opportunities in alignment with the organization’s growth strategy - Perform strategic and financial analysis on global and regional transaction opportunities - Coordinate and manage the appropriate due diligence process for transaction opportunities - Participate in relevant industry conferences - Proactively seek opportunities to extend business relationships by expanding existing partnerships or creating additional collaborations - Develop collaborative and productive relationships cross-functionally within the organization - Assemble and effectively utilize internal and external resources (as necessary) to ensure adequate support of each transaction
Job ID
2020-1538
Job Locations US-MA-Newton
SUMMARY: 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. They collaborate closely with the safety physician and cross-functional partners to evaluate and actively manage risks in accordance with global regulatory frameworks RESPONSIBILITIES: - 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 Operations, Biostatistics, Regulatory Affairs, Contract Research and other entities as needed - Contribute to health authority and other safety-related query responses - 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), including project management, safety database requests, understanding and writing the content, assimilating information from other groups, and quality checks - Plan and execute literature surveillance - Provide leadership in the development, implementation, and maintenance of robust procedures for the planning, preparation, and submission of high-quality safety reports - Support PV activities as needed
Job ID
2020-1536
Job Locations US | US | US | US | US | US
SUMMARY: The Managed Care Liaison (MCL) is responsible for building relationships with and providing advanced scientific and health outcomes support to regional and national managed care organizations, health care systems, government payers, and other organizations that are involved with medication formulary decisions. The MCL also provides field-based representation to facilitate research, education, and other collaborations, in compliance with applicable SOPs.The MCL is a field-based medical role that will serve as a strategic partner to the HOLs, MSLs, and CADs. RESPONSIBILITIES: - Coordinate and deliver scientific, value, and disease awareness information as presentations or other forms of scientific exchange to national/regional managed care organizations, pharmacy benefit management companies, health care systems, government payers, and relevant medical and scientific professionals involved with formulary decision making - Communicate key insights to internal colleagues including HOLs, MSLs, and CADs - Identify and develop professional relationships with national and regional managed care organizations and relevant thought leaders - Identify potential research gaps and assess the research capabilities of national and regionally based managed care organizations - Assist in the development of educational managed care focused tools/resources to help support value and access - Provide reactive presentations to managed care accounts on KPT pipeline and/or other requested scientific information where appropriate - Provide training support to CADs and other internal stakeholders - Evaluate and present opportunities for value-based contracting - Complete all required training, activity documentation, expense reporting, and other administrative responsibilities. Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners - Provide session coverage at relevant scientific and professional meeting including AMCP, NAMCP, ASHP, and NCODA - Other duties and responsibilities as assigned
Job ID
2020-1535
Job Locations US-MA-Newton
Summary This position is responsible for delivering high quality accounting documentation and analytical support.  The Senior Accountant must also ensure the accuracy of the Company’s consolidated financial records and will be responsible for assisting with the monthly close process, various quarterly and year-end reporting requirements as well as be involved with special projects. This position works closely with the Accounting department staff as well as other members of the Finance organization.   This position may also work closely with other areas including the legal department. - Prepare account analysis and reconciliations for various balance sheet and P&L accounts - Calculate, analyze, and process various entries including investment entries, vendor accruals, prepaid entries, fixed asset entries and other various recurring entries - Cash entry postings - Cash and Investment reporting / forecasting - Assist in quarterly review and annual audit preparations and process - Assist with SOX compliance efforts in the finance area by performing established control procedures, documenting related internal control processes, and testing to ensure these controls are adhered to - Perform ad hoc and special projects as requested by management and associated with the growth of a life sciences company.
Job ID
2020-1534
Job Locations US-MA-Newton
The Senior Biostatistician / Senior Manager, Biostatistics will be a key member of clinical study teams responsible for the development and conduct of statistical analyses contributing to the submission of publications and presentations arising from Karyopharm-sponsored clinical studies. Duties will include participate in designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation and reporting of preliminary and final study results. The ideal candidate is a good communicator with high- energy, self-motivated and a forward thinker. - Be accountable for all statistical aspects of protocols and regulatory submissions for assigned clinical studies - Work with clinical, pharmacovigilance, and regulatory personnel in preparation of statistical documents (e.g. statistical analysis plans) and analyses (e.g. safety and efficacy analyses) to support DSMB/DMC meetings, Development Safety Update Reports, and investigative brochures - Work with data management personnel in the preparation of data sets that are of high quality and in usable format - Work with medical writing personnel in preparation of clinical study reports and other regulatory documents including NDA - Work with publications and data analytics personnel in the preparation of meeting abstracts/presentations and analytical reports of preliminary data from ongoing clinical studies - Proactively mentors and trains subordinates to continually improve processes and procedures in support of internal and external customers - Guide team in the design and analysis of clinical studies using appropriate and innovative statistical methods - Review draft presentations and training materials, including posters and slide decks, according to deadlines
Job ID
2020-1531
Job Locations US-MA-Newton
This role is responsible for ensuring continuous product supply for Karyopharm’s drug products (IMP) in support of clinical trials.  The individual will work with internal and external customers and suppliers in order to accomplish project objectives. The individual will develop IMP packaging and distribution plans and manage Clinical Supplies documentation requirements. Responsible for monitoring inventory levels and providing feedback to the appropriate resources regarding expiry and resupply. In addition, the individual will support Clinical Supply Chain initiatives and continuous improvement activities.   - 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 an assist in establishing new departmental procedures
Job ID
2020-1526
Job Locations US-MA-Newton
The Director, HR Business Partner is both a strategic and hands-on position that provides full cycle HR support.  This person will be a critical team member who can influence and drive change within our Commercial and G&A groups and will be able to thrive in a fast-paced environment.  With our recent launch of Xpovio along with our strong oncology pipeline, this position will play a key role in Karyopharm's continued growth. - Within our G&A and Commercial client groups, provides advice and counsel to managers and employees on various issues to including the interpretation of HR policies and procedures. - Leads investigations, terminations, PIPs and flexible work arrangements, supporting managers and employees during the process. Collaborates with Legal as required - Participates in the development and implementation of new HR policies and procedures according to relevant labor law and policy guidelines. - Collects, researches, and analyzes HR data for assigned projects, and then makes recommendations. - May participate in the development, implementation, communication, and administration of multiple HR programs and/or activities. - Partners with hiring managers to develop/implement successful departmental and cross functional onboarding plans for the first 90 days - Facilitates excellence in the implementation of Karyopharm people practices, including Performance Management, Career Development: identification of Top Talent; Workforce Planning. - Partners with employees and managers at all levels to address and resolve employee relations matters as needed - Contributes to the development and delivery of manager education initiatives.
Job ID
2020-1524
Job Locations US-IL | US-MN
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
2020-1520
Job Locations US-TX | US-TX | US-NM | US-AR | US-LA
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
2020-1519
Job Locations US-TX | US
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
2020-1511
Job Locations US-MA-Newton
We are seeking a highly experienced, strategic commercial leader for the role of Senior Director, New Product Planning.  This position will play a critical role in guiding Karyopharm’s global commercial strategy, portfolio strategy, and early commercial planning for late stage assets.  This position will report to the Vice President of Marketing and is based in Newton, MA. - Work cross-functionally with the various program teams and Market Analytics to conduct comprehensive market assessments on key disease areas and evaluate opportunities for pipeline assets - Identify critical knowledge gaps in key disease areas and partner with Market Analytics to develop and execute primary and/or secondary market research to address them - Communicate key disease area/market insights to relevant internal stakeholders, identifying considerations and implications for development strategies - Partner with Market Insights, Forecasting and Analytics to develop global forecast models that accurately assess the market opportunity associated with pipeline candidates in different indications - Partner with operations and program leadership to develop NPV-based business cases and decision frameworks for evaluation of pipeline opportunities - Develop and propose early commercial strategies, value propositions and a prioritized approach to potential label indications - Collaborate with internal stakeholders to develop, update and maintain Target Product Profiles (TPPs) for Karyopharm’s early oncology assets - Partner with Program Leadership and cross-functional leadership to develop global strategic plans for pipeline assets - Provide commercial input and strategic guidance to cross-functional program teams to inform key business and development decisions - Provide commercial input on business development evaluations - Develop and maintain strong, internal partnerships with cross-functional colleagues (e.g. program team, commercial, regulatory, CMC, clinical, business development, research etc.). - Ensure successful agency/vendor partnerships and develop and manage budgets - Develop and deliver presentations to senior leadership
Job ID
2020-1505
Job Locations US-MA-Newton
The Senior Medical Director will serve as the primary medical lead for Karyopharm clinical trials with cross-functional study teams on clinical trial strategy, design and execution. Along with this, the Medical Director will serve as the primary Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials. This individual will work on multiple trials in Phases 1 through 3.   - Participates in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans and other key study documents in conjunction with other line functions and with minimal guidance. - Serves on cross-functional teams for assigned trials, working with other team members to achieve efficient, high-quality study execution. - Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of IND’s and CTA’s, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate. - Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR). - Acts as liaison between Clinical Development and other internal groups at Karyopharm (e.g., Regulatory Affairs, Clinical Operations, Clinical Data Management) for assigned studies. - Develop and execute life-cycle management plan, lead data generation activities such as medical affairs studies to unmet medical needs and data gaps - Support Medical Affairs: Working with field medical, Scientific Communication and Publication, Medical Information and Communication teams and provide support including reactive material development to address external stakeholder questions - Help identify and effectively interact with thought leaders to engage in scientific and medical exchange as well as understand unmet medical needs and data gaps - Support IST Program - Partner with pharmacovigilance to assess the safety profile of compounds - Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators and internal stakeholder. - Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives - Maintain ethical standards of the highest level and have the knowledge and ability to comply with all relevant ethical, regulatory, and legal standards - May participate in or lead clinical development contributions to due diligence or other business development activity - As required by program needs, contribute in partnership with Discovery colleagues to the design and implementation of translational strategies - Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule - Present at scientific, medical and regulatory meetings globally - Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOL’s, and patient advocacy groups - Contribute to activities in support of the company’s planned NDA submissions. Author clinical sections for INDs, NDAs, and other related documents
Job ID
2019-1492