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
As a Karyopharmer, reporting to the Field Medical VP, you will positively impact patients’ when you: The Senior MSL is an experienced oncology professional with scientific, clinical, and therapeutic area expertise responsible for providing medical expertise on all the Karyopharm assets in development. The Senior MSL is a highly valuable member of the Global Medical and Scientific (GMSA) team who represents Karyopharm externally by engaging in highly credible scientific discussions with targeted Key Opinion Leaders (KOLs), internal stakeholders, clinical trial investigators, access stakeholders and other healthcare professionals to help support the medical objectives at Karyopharm.  We are looking for someone who approaches the role with thoughtful consideration of the future and is willing to take risks. This role will support our Mid Atlantic territory - VA, WV, MD, DE, DC, Eastern PA, Southern NJ, Eastern NC - Identifies and develops creative, innovative approaches for external engagement - Partners with leadership to develop strategies that will adapt medical affairs to the evolving external environment - Understands oncology treatment paradigms, key stakeholders, and healthcare landscape within the designated coverage area (regionally and/or locally) and within assigned institutions. - Identifies disease concepts and compound characteristics that can be leveraged into product differentiation - Represents the company at educational events, programs, medical meetings and scientific congresses - Identify, engage, and cultivate relationships with key opinion leaders (KOLs), clinicians, investigators, and other HCPs within academic and community settings in accordance with compliance guidance for Medical Affairs activities. - Identifies and engage key KOLs, HCPs, and investigators in scientific exchange on disease landscape & Karyopharm’s assets. - Serves as a key member of the Karyopharm GMSA team to share actionable insights/learnings to help inform and develop the medical strategy. - Collaborates with other cross-functional internal team members (i.e., commercial, payer/access, clinical development) to share regional/local insights/learnings and contribute to respective strategies. - Provides support for congress meetings, including scientific coverage, competitive intelligence, medical booth staffing and external engagements. - Delivers medical/scientific presentations to internal & external stakeholders. - Responds to external inquiries and deliver appropriate clinical and scientific information - Responsible for individual documentation of field engagements and contributes to aggregate reporting of the Field Medical Team activities and value to the company. - Responds to external inquiries and deliver appropriate clinical and scientific information - Represents Karyopharm at select scientific congresses and professional society meetings - Travels to meetings, face-to-face engagements, as required, estimated at 60%.
Job ID
2022-2100
Job Locations US-Remote
As a Karyopharmer, reporting to the Field Medical VP, you will positively impact patients’ when you: The Senior MSL is an experienced oncology professional with scientific, clinical, and therapeutic area expertise responsible for providing medical expertise on all the Karyopharm assets in development. The Senior MSL is a highly valuable member of the Global Medical and Scientific (GMSA) team who represents Karyopharm externally by engaging in highly credible scientific discussions with targeted Key Opinion Leaders (KOLs), internal stakeholders, clinical trial investigators, access stakeholders and other healthcare professionals to help support the medical objectives at Karyopharm.  We are looking for someone who approaches the role with thoughtful consideration of the future and is willing to take risks. This role will support our Great Lakes territory - MI, OH, KY, Nashville, Western PA & Western NY - Identifies and develops creative, innovative approaches for external engagement - Partners with leadership to develop strategies that will adapt medical affairs to the evolving external environment - Understands oncology treatment paradigms, key stakeholders, and healthcare landscape within the designated coverage area (regionally and/or locally) and within assigned institutions. - Identifies disease concepts and compound characteristics that can be leveraged into product differentiation - Represents the company at educational events, programs, medical meetings and scientific congresses - Identify, engage, and cultivate relationships with key opinion leaders (KOLs), clinicians, investigators, and other HCPs within academic and community settings in accordance with compliance guidance for Medical Affairs activities. - Identifies and engage key KOLs, HCPs, and investigators in scientific exchange on disease landscape & Karyopharm’s assets. - Serves as a key member of the Karyopharm GMSA team to share actionable insights/learnings to help inform and develop the medical strategy. - Collaborates with other cross-functional internal team members (i.e., commercial, payer/access, clinical development) to share regional/local insights/learnings and contribute to respective strategies. - Provides support for congress meetings, including scientific coverage, competitive intelligence, medical booth staffing and external engagements. - Delivers medical/scientific presentations to internal & external stakeholders. - Responds to external inquiries and deliver appropriate clinical and scientific information - Responsible for individual documentation of field engagements and contributes to aggregate reporting of the Field Medical Team activities and value to the company. - Responds to external inquiries and deliver appropriate clinical and scientific information - Represents Karyopharm at select scientific congresses and professional society meetings - Travels to meetings, face-to-face engagements, as required, estimated at 60%.
Job ID
2022-2092
Job Locations US-Remote
As a Karyopharmer, reporting to the Associate Vice President, Global Head of Medical Affairs Strategy and Excellence, you will positively impact patients’ when you: - Lead and provide scientific leadership and support for compounds in various stages of clinical development, as well as approved products in the Hematology/Oncology and Solid Tumor Therapeutic Areas. - This individual will be involved in integrated strategic planning and execution within Global Medical and Scientific Affairs (GMSA), as well as with partners in the US Commercial organization, Research and Development and Market Access, and will lead medical affairs activities for Hematologic Malignancies / Solid Tumors. - He/she will represent GMSA in hematologic malignancies and solid tumor initiatives with broad responsibilities and impact across the US business and overall GMSA organization. Particularly, he/she will work closely with the Global Medical Affairs and cross-functional Program Teams to support and prepare for the US launch of new products and label expansion. - Lead and support development and execution of medical strategies in close collaboration with Program Team members within the assigned therapeutic area(s). - Ensure the development of effective evidence generation strategies, medical education, scientific communication strategies and training to drive launch excellence. - Partner with GMSA leads, as well as cross-functional leaders in Research and Development and Commercial to lead and execute medical tactics in the assigned therapeutic area that is aligned with the Brand strategy. - Supports the development of robust publication and congress strategies for assigned therapeutic areas in partnership with cross-functional leads. - Serve as lead for major congresses, ensuring cross-functional alignment and execution in relevant therapeutic areas. - Lead and support the development of a robust engagement strategy with Oncology thought leaders and build advocacy with top-tier individuals. - Work closely with Field Based Medical Affairs on training, messaging, and prioritization of field activities to ensure successful execution of tactics supporting the overall medical strategy. - Generate actionable insights to aid the medical, clinical and marketing teams to identify gaps and influence drug/brand development. - Serve as the subject matter expert for internal and external programming, including symposia, advisory boards, and steering committees.
Job ID
2022-2090
Job Locations US-MA-Newton | US-Remote
As a Karyopharmer, reporting into the Vice President of HR, the Associate Director HR Business Partner will play a critical role in driving a high-performance culture within Karyopharm.  The goal of the Business Partner is the development and successful deployment of HR programs and policies within the organization.  Additionally, the HRBP serves as a consultant to the senior leadership in the identification of key results and HR metrics.  To be successful in this position, you will feel comfortable alternating between high-level strategy, and day-to-day tactical work to people managers and employees. You will collaborate with other members of our HR team to ensure consistent execution of our programs. - Serve as a trusted resource for staff, managers and senior leadership, providing sound HR advice and judgment on all people related matters. - Support managers in organizational change and employee relations issues. - Monitor employee engagement through data, stay & exit interviews, and recommend engagement strategies and programs. - Manage and resolve complex employee relations issues by conducting effective, thorough and objective investigations to completion including manager coaching and employee counseling. - Make recommendations, project manage and implement solutions to streamline or enhance HR processes. - Perform analysis of operational and HR metrics to assess effectiveness of programs and practices and report out to Karyopharm’s leadership team. - Drive the integration of performance and business management processes to ensure clarity of goals and expectations for business results, align performance with rewards, and drive a culture of accountability for results. - Facilitate and execute talent management initiatives to identify, assess, develop, engage and reward our people. - Develop workforce plans, identifying current state, future needs, gaps, and plans to fill gaps. Focus on areas of retention risk, high potential talent development needs, and internal/external strengths, weaknesses, opportunities and threats to the achievement of business unit goals. 
Job ID
2022-2089
Job Locations US-Remote
Reporting to the EVP, Chief Development Officer, the (S)VP, Development Operations is responsible for leading Development Operations for Karyopharm Therapeutics to achieve program objectives and ensure successful completion of all clinical trials and related clinical trial milestones within established timelines and budgets.  The SVP, Development Operations is responsible for the planning and execution of all clinical studies in the Karyopharm portfolio and leads the Clinical Operations, Data Management and Medical Writing functions.  In addition, the SVP Development Operations plays a key role as a part of Karyopharm’s Senior Leadership Team, driving continuous improvement and the organization’s ICARE culture and values. - Responsible for leading a team of clinical operations professionals to strategically plan and execute clinical trials achieve program objectives and high-quality deliverables within established timelines and budgets - Serves as direct line management of the Clinical Operations, Data Management and Medical Writing functions for Karyopharm - Responsible for partnering cross-functionally to ensure that department planning and resourcing is aligned to program deliverables and organization needs - Accountable for developing and empowering staff and teams to achieve program goals - Accountable for establishing program metric tracking tools and performance goals - Lead and/or participate in the development and review of department policies, SOP’s and other control documents - Leads partnership with external stakeholders to support Karyopharm clinical operations and data management projects including partners, vendors and other key stakeholders - Develop and maintain systems for effectively managing service provider relationships including identifying and reviewing key performance indicators throughout the contract in partnership with Vendor Management and Quality - Responsible for ensuring operational excellence in our clinical stage programs by applying high industry standards, policies, systems, and processes across all trials - Maintain and improve professional knowledge of technological advancements in clinical research and potential applicability for Karyopharm’s portfolio
Job ID
2022-2088
Job Locations US-Remote
The Senior Clinical Project Manager  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. As a Karyopharmer, reporting to the Senior Director of Clinical Operations, you will positively impact patients’ when you: - 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 - 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 - May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance - 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 - Requests and critically evaluates proposals and change orders from CROs and vendors - Attend relevant symposia, conferences and scientific meetings, as necessary - May directly manage or line manage other clinical operations staff members - Up to 20% domestic and/or international travel may be required
Job ID
2022-2086
Job Locations US-MA-Newton
The Accounts Payable and GL Accountant position will report to the Senior Manager, Accounts Payable, and will be responsible for accounts payable, T&E management and auditing, owning our American Express corporate credit card program, and performing general ledger journal entries and reconciliations. This position should be someone who is collaborative, team-orientated, and willing to jump-in on assignments and projects as that arise.   - Create and run payment cycles (ACH, wires, checks) and review exceptions / resolve vendor payment disputes - Work with the AP team and others to ensure that purchase orders and invoices are tracked properly - Communicate both orally and in writing with suppliers and internal employees - Assist Business Unit users in the creation of purchase order requisitions and following up on understanding purchase order reporting - Manages and maintains Concur expense system and American Express Corporate Card program - Reviews and verifies propriety of expense reports for officers, sales management and internal employees - Uploads approved T&E expenses to Great Plains - Administers all employee profile information within Concur and ensure that employee access is granted and removed in a timely manner - Follows up with expense users and approvers regarding unreported charges - Provides support to Concur/Amex users, answering questions, resetting passwords, and reporting issues to Concur as needed - Perform regular audit of the employee expense reports and prepare audit report for management review - Become the subject matter expert for expense report processing and purchasing card programs and provide training as needed - Completes monthly reconciliation of Concur and Amex transactions to ensure readiness for monthly accounting close process - Generate report for payroll by receiving and verifying expense reports and requests for advances - Collaborate with Human Resources regarding policy changes and changes in employee statuses - Troubleshoot workflow issues between Concur and Great Plains - Also performs similar duties, as needed, for separate international credit card program(s) - Assists Accounts Payable and finance team as needed, including Ad hoc assignments and responsibilities
Job ID
2022-2083
Job Locations US-Remote
As a Karyopharmer, reporting to the Senior VP of Regulatory Affairs, you will positively impact patients’ when you: - Accountable for the prescribing information and related materials (referred to as “labeling”) of assigned product(s) for the purpose of regulatory submissions, maintenance and compliance - Accountable for the oversight and compliance of product artwork for the assigned product(s) - Responsible for the development and maintenance of the product labeling in collaboration with internal stakeholders - Partner with internal stakeholders to develop and maintain the Core Company Data Sheet - Contribute to applicable regulatory strategies for all projects with impact to labeling - Develop, champion, and lead all applicable internal Committees and the associated processes with respect to approvals of labeling changes - Provide support to review advertising and promotion and/or medical materials through PART and/or MMRT, as needed - Provide support and contribute to Regulatory Intelligence, Regulatory Science, and Regulatory Policy with focus on labeling; and when necessary, conduct detailed analyses - Serve as an internal expert on FDA and EMA labeling requirements
Job ID
2022-2081
Job Locations US-Remote
The VP, Research &Translational Medicine will oversee all areas of preclinical development at Karyopharm including but not limited to bioinformatics, biomarker development, identification of rationale combinations, and mechanism of resistance to SINE inhibition.  This role works cross-functionally and amongst all Karyopharm program teams, oversees collaborators, consultants and CROs, and will manage internal teams.    As a Karyopharmer, reporting to our Chief Medical Officer, you will positively impact patients’ when you: - Playsanimpactfulstrategicandoperational roleinthecompany'sclinical research - Ensures optimal operational performance and synergies across various research interests. Creates initiatives to establish R&D teams and pathways that fully harness the company's scientific platform and therapeutic opportunities - Provides input on clinical protocols including collection of patient samples and analyses to be performed. Works with clinical operations to ensure all samples are collected as outlined in the protocol. - Contributes to INDs, NDAs (new drug application) or its supplements to provide preclinical or non-clinical data in further support of the clinical data - Contributes to a PMA (premarket approval) application in support of a device approval - Builds and maintains strong internal and external relationships. Leverages those relationships to remain informed, create collaborations, and achieve goals that might not be attainable relying only on internal resources. Identifies and proactively cultivates partnerships with academic institutions, life science companies, and health authorities in order to attain company goals. - Supervises internal and CRO study-related activities through IND and IND assembly and submission - Oversees assay development - Ensures highest caliber of internal staff through hiring, mentorship and appropriate oversight and an effective network of outside partners, collaborators and service organizations. - Initiates and manages relationships with third parties such as KOLs and academic partners in specific disease areas - Manages the overall budget for the function. - Participates in the evaluation, selection, and management of CROs, contractors, and vendors
Job ID
2022-2080
Job Locations US-Remote
Reporting into the EVP, Chief Development Officer, the VP Quality is accountable for leading all aspects of the Karyopharm Quality System and ensuring compliance with GxP requirements. You will positively impact patients’ when you:   - As a senior leader of the organization, develop short and long range quality plans and strategies that support Karyopharm investigational products. - Provide leadership and guidance to the organization regarding quality, training and inspection readiness. - Analyze and make recommendations for improving QA systems as well improving vendor compliance with FDA, international regulatory authorities and ICH regulations and guidelines - Develop and implement strategies for the timely preparation and execution of quality submissions to regulatory authorities for all phases of the product life cycle - Lead the global quality organization to ensure compliance with GXP requirements - Maintain a quality organization and system that will provide Karyopharm with a competitive advantage in the market place - Ensure Karyopharm is in compliance through policies, standards and audit systems - Establish the proper environment to ensure that there is a quality focus in all activities of the business - Direct the QA auditing program which includes assessing outside contractors, conducting internal and external quality audits and managing regulatory inspections - Review and evaluate complaint records and investigation process for complaints - Enhance product quality documentation system - Manage budgets, control cost and analyze variances - Oversee company-wide training compliance for all of quality - Actively engage in appropriate activities to influence and meet the changing needs of the regulatory environment through QA and other venues. - Provide guidance and support for Quality Management Review.    
Job ID
2022-2079
Job Locations US-Remote
As a Karyopharmer, reporting to the Senior Director Regulatory Affairs, you will positively impact patients’ when you: - Accountable for the execution of regulatory strategies including, but not limited to, compiling regulatory submissions such as IND, CTA, Amendments, and support major submissions such as (s)NDA, MAA, variations, etc. - Act as the conduit between external functions and Regulatory Operations to ensure execution excellence of assigned submissions - Lead Regulatory initiatives including Regulatory Intelligence and Regulatory Science projects, compliance activities, and assigned tasks - Maintain Regulatory Strategy Documents for assigned programs - Co-chair Regulatory Subteam with the Global Regulatory Lead - Accountable for submissions such as Annual Reports and Renewals for assigned products
Job ID
2022-2075
Job Locations US-LA-Baton Rouge | US-Remote
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
2022-2073
Job Locations US-Remote
The Head of Medical Writing will lead our medical writing team to establish document strategy, timelines, develop work plans, ensure cross functional alignment and timely delivery of high quality clinical and regulatory documents and presentations that are aligned with Karyopharm’s portfolio program strategies. As a Karyopharmer, reporting to the SVP of Development Operations, you will positively impact patients’ when you: - Establish medical and regulatory writing best practices (templates, SOPs, work instructions, document review, document timelines) to ensure consistency and quality of documents - Lead writing team to ensure timely generation of key documents in partnership with the relevant functions (Clinical Study Protocols, Clinical Study Reports, responses to Information Requests from regulatory agencies, major regulatory submissions including Meeting Requests, Meeting Packages, and Marketing Applications, and more) - Coordinate document writing, review and revision to ensure the highest quality and in alignment with program strategy and objectives. Perform key functional activities as required per deliverable - Proactively plan future deliverables to ensure organizational alignment and preparation for document reviews in an efficient manner - Oversight of medical and regulatory writing vendors in alignment with Karyopharm internal resources, methods, SOPs, and overall approach - Identify critical departmental issues, generate recommended plans to address the critical issues and present recommendations to R&D Leadership team - Work closely with external subject matter experts, supported by significant preparation, to obtain input required for timely completion of documents - Develop departmental goals consistent with corporate goals - Ensure that the medical writing team is fully informed on Karyopharm policies, standards and expectations - Provide guidance to medical writing team to support career development and resolve intra- and inter-departmental conflicts - Set expectation (explicitly and by example) for staff and teams to work according to Karyopharm ICARE core values, and to interact with other employees in a professional and respectful manner
Job ID
2022-2071
Job Locations US-MA-Newton
In this newly developed role, you will partner with the HR leadership team to lead the strategy, design, development, and implementation of key programs in the areas of performance management, talent planning, leadership development, and team effectiveness. This role requires a business impact mindset while also embedding inclusion at the core of our practices. The successful candidate will collaborate across the organization to drive organizational impact through innovative and fresh ideas that foster an environment where employees can grow, thrive, and do their best work! This is an individual contributor leadership role that will leverage the support of HR team and external partnerships to deliver on goals.   - Build out and implement KPTI’s next iteration of talent management practices including performance management, succession planning, & top talent/potential initiatives. Design and deliver best-in-class experience - Be a strategic thinker, bring best practices but tailor for context and be a hands on executor - As a trusted advisor and partner to leadership, identify performance needs and gaps in order to direct the design and execution of learning and development strategies across the organization - Develop and implement KPTI’s learning strategy and annual roadmap in partnership with the executive team and key business stakeholders to identify high-priority development experiences (i.e., coaching, leadership development, upskilling) - Seek and build partnership opportunities (internally and externally) to implement and continuously improve learning and talent development tools and processes - Define and implement a measurement strategy to assess the effectiveness of performance and learning interventions - Partner with Human Resource Business Partners to conduct needs assessments, organization listening, and recommend appropriate team effectiveness solutions. - Design,implement and facilitate learning/developmental initiatives for target audiences to drive engagement, growth, and performance 
Job ID
2022-2068
Job Locations US-Remote
The VP, Medical Lead is a member of the CMOs leadership team. This individual will liase with Myelodysplastic Syndrome (MDS) opinion leaders in the US and the rest of the world, will serve as a member of the program development team, and work with the medical monitors to ensure optimal study design and oversight of Karyopharm clinical trials developed in Myelodysplastic Syndrome (MDS). In addition, this role serves as a champion for the vision and culture that is central to the team’s growth in Myelodysplastic Syndrome (MDS).  The VP, Medical Lead will cultivate a patient-focused mindset with science at the core as Karyopharm focuses on key priorities and the pipeline.   As a Karyopharmer, reporting to our Chief Medical Officer, you will positively impact patients’ when you: - Represent Karyopharm as a leading voice Myelodysplastic Syndrome (MDS) voice both internally and externally - Work to advance the company’s key priorities and maintain a strong clinical pipeline - Work cross-functionally to ensure alignment around strategy and goals, including scientific publications, conferences, clinical trials, and capabilities development - Partner with Product Leaders, Launch Excellence, and Field Teams to ensure a consistent voice for Karyopharm – compliantly and appropriately. - Working with key stakeholders to assist in preparation for meetings, facilitating corporate presentations and memorandums to the Board - Represent Karyopharm with regulatory agencies, as needed - Participate in the medical review process for all materials and decisions that require cross-functional input and/or review, as needed by existing governance committees - Identifying and building processes that support the vision, culture, and strategic plans of the medical science function, enhance productivity, and improve collaboration - Acting as a liaison between staff and senior executives regarding functional culture and employee satisfaction - Coordinating development of internal and external presentations, securing input from cross-functional knowledge experts - Serving as a conduit for medical affairs initiatives to US medical science function - Works closely with the medical monitors and clinical research scientists to ensure optimal protocol development, medical monitoring, and data analysis. - Contributes to relevant clinical sections across various documents including but not limited to INDs, CSRs, IB’s, DSURs, NDA/sNDAs
Job ID
2022-2062
Job Locations US-Remote
The VP, Medical Lead is a member of the CMOs leadership team. This individual will liase with myelofibrosis opinion leaders in the US and the rest of the world, will serve as a member of the program development team, and work with the medical monitors to ensure optimal study design and oversight of Karyopharm clinical trials developed in myelofibrosis . In addition, this role serves as a champion for the vision and culture that is central to the team’s growth in myelofibrosis. The VP, Medical Lead will cultivate a patient-focused mindset with science at the core as Karyopharm focuses on key priorities and the pipeline.   As a Karyopharmer, reporting to our Chief Medical Officer, you will positively impact patients’ when you: - Represent Karyopharm as a leading voice Myelofibrosis voice both internally and externally - Work to advance the company’s key priorities and maintain a strong clinical pipeline - Work cross-functionally to ensure alignment around strategy and goals, including scientific publications, conferences, clinical trials, and capabilities development - Partner with Product Leaders, Launch Excellence, and Field Teams to ensure a consistent voice for Karyopharm – compliantly and appropriately. - Working with key stakeholders to assist in preparation for meetings, facilitating corporate presentations and memorandums to the Board - Represent Karyopharm with regulatory agencies, as needed - Participate in the medical review process for all materials and decisions that require cross-functional input and/or review, as needed by existing governance committees - Identifying and building processes that support the vision, culture, and strategic plans of the medical science function, enhance productivity, and improve collaboration - Acting as a liaison between staff and senior executives regarding functional culture and employee satisfaction - Coordinating development of internal and external presentations, securing input from cross-functional knowledge experts - Serving as a conduit for medical affairs initiatives to US medical science function - Works closely with the medical monitors and clinical research scientists to ensure optimal protocol development, medical monitoring, and data analysis. - Contributes to relevant clinical sections across various documents including but not limited to INDs, CSRs, IB’s, DSURs, NDA/sNDAs
Job ID
2022-2061
Job Locations US-MN | US-Remote | US-MN-Minneapolois
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
2022-2059
Job Locations US-Remote
The Senior Clinical Research Scientist (CRS) position serves a key role within the Clinical Development R&D team.  The Senior CRS works closely with the assigned study team(s) and medical director(s) to support the activities associated with one or more clinical studies. This position collaborates with clinical team members as well as with functions outside of clinical to provide high quality and timely deliverables. Your are responsible for achievement of personal goals which support study team, project team, and corporate goals. - Support assigned study level activities for one or more clinical studies. - Develop thorough understanding of assigned protocol and protocol requirements - Support study start-up/conduct/close-out activities as applicable: - Preparation, storage, maintenance of clinical documents (TMF) - Participate in the protocol development process; including writing, reviewing, adjudication/resolution of cross functional comments, ensuring high quality final document - Thorough understanding of assigned protocol and protocol requirements - Perform medical monitoring duties, with moderate supervision provided by the medical director - Participate in review and validation of clinical study reports (CSRs) - Contribute to review of Regulatory Documents (e.g., IB, Briefing Books) in collaboration with medical writers with minimal to moderate supervision - Review/Edit Informed Consent Forms (ICF); review/edit regional and site ICFs as needed; ensure alignment with protocol - Active contributor to study committee (e.g., DMC) activities such as charters, meetings, presentation preparation - Active contributor to Investigator Meeting and Site Initiation Visit presentation preparation - Active contributor to activities related to data generation and validation, including CRF creation, clinical data review, data cleaning, communication as needed to resolve data queries, contribute to development of data review plans, support medical director and pharmacovigilance physicians 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 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 - Identify, escalate current/active/future issues; propose and enact solutions - Strong presentation skills, including ability to prepare and deliver comprehensive presentations to both internal and external audiences
Job ID
2022-2057
Job Locations US-Remote
Karyopharm is seeking an Associate Director/Director of Clinical Pharmacology & Pharmacometrics to lead oncology programs in early and late stages of clinical development — contributing to the design, planning, execution, data analysis, and interpretation of Clinical and Clinical Pharmacology studies. He/she should be familiar with current practices in most of the following areas: clinical pharmacology, regulatory affairs, DMPK, bioanalytical assay and pharmacometrics. He/she should have a strong knowledge of best regulatory practices, extensive experience designing and executing clinical pharmacology studies, and a demonstrated ability to make data-driven decisions based on pre-clinical and clinical information.   As a Karyopharmer, reporting to Vice President, Clinical Pharmacology, you will positively impact patients’ when you: - Conduct quantitative pharmacology analyses including NCA, population PK, exposure/response, and PBPK to streamline drug development and guide critical decisions including dose selection within the target patient population including sub-populations - Lead the design and development of Clinical Pharmacology submission documents for regulatory filings and Represent Clinical Pharmacology in regulatory interactions - Plan and execute nonclinical ADME studies - Assist with study design and interpretation of nonclinical pharmacology and toxicology studies including application of translational methods - Review and provide inputs on the bioanalytical assay and validation report - Collaborate cross-functionally with other departments, such as Biostats, Clinical, Translational Science, PV and Regulatory
Job ID
2022-2036