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
The Sr. Specialist, IMP Quality will: Assist with all Quality Unit (QU) efforts and activities, including Quality Assurance (QA) and Quality Control (QC) within the organization and the Contract Service Providers, including the development and implementation of the programs. Assist with all CMC Quality activities in support of Phases 1-3.
- Review and evaluate Production Batch Records for API and Drug Product, including data generated by different functions, and accordingly approve the final disposition and release of finished product.
- Review batch records and associated data to ensure all approved procedures were followed and all specifications were met. Track non-compliance events that occur during production and testing.
- Review and approve batch records for labeling and packaging operations. Ensure proper version control and document integrity of packaging component labeling, specifications, printed labeling artworks and other assigned labeling documents.
- Review regulatory documents to ensure accuracy against source data.
- Ensure Karyopharm’s quality expectations are being met in the areas of Good Manufacturing Practice, Good Laboratory Practice, Good Distribution Practice and Good Documentation Practice.
- Partner with our Analytical function to review all stability testing data from studies performed for Karyopharm. Establish trends and ensure data is analyzed to help understand degradation pathways and to help develop specifications.
- Partner with our Analytical function to review and approval protocols associated with stability, method validation and method transfer.
- Propose quality improvements to Quality Systems to maintain compliance and improve efficiency as part of continuous improvement initiatives
Reporting to the Chief Commercial Officer, this role will be responsible for driving innovation across the Commercial organization by partnering internally across field-based, local and functional teams as well as with external stakeholders. The Senior Director, Commercial Innovation will lead the development & execution of an experimentation framework driving innovation & agile optimization for the brands as well as infusing a test & learn culture across the organization.
- Enhance the commercial value offering, including but not limited to digital innovation, enhanced HCP engagement strategy, patient value, and value-based care
- Identify opportunities with strong potential for commercial and/or patient value creation, and design and execute pilots to strategically disrupt the market and differentiate Karyopharm offerings
- Drive new ways of doing things and experimentation to drive growth against new targets, sales channels and customer segments
- Lead a test-and-learn approach to commercial innovation, including rapid prototyping, testing, designing and scaling leading-edge customer experiences
- Set the innovation agenda and assist the CCO to define innovation priorities
- Provide deep knowledge and expertise on the competitive global market and customer engagement trends to commercial and other functional partners
- Develop an assessment framework for pilots to evaluate impact and predict future success
- Facilitate workshops and discussions to generate, evaluate and prioritize ideas and scope innovation projects, in order to establish clear priorities for maximum business throughput
- Monitor pilots against expectations and make recommendations to kill early, improve or scale
- Develop business cases and, working closely with cross-functional partners, implement plans to scale pilots and embed into existing commercial team
We are seeking a Director / Sr. Director, Engagement & Awareness to serve as the leader of a small team that will focus on innovative ways to drive awareness of Karyopharm Therapeutics, our innovative science and our FDA approved drug, XPOVIO (selinexor), for our non-commercial stakeholders. This role will focus on building awareness and bridging relationships across broad communities, including patients, advocates, physicians and other healthcare providers, biotech and pharmaceutical industry partners, elected officials, academia, media, the employment market, and other stakeholders who may intersect with Karyopharm. Campaigns and projects will include a focus on social media, advocacy groups, and other traditional and nontraditional channels to create awareness for Karyopharm, our science and selinexor to a broader community. This role will report into the Chief People & Corporate Engagement Officer.
- In adherence with Company strategic direction, drive global external communications strategy and execution for selinexor and our other assets, focused on raising awareness and our mission among relevant stakeholders, improving understanding of our innovative technology and increasing positive coverage related to the company, science and programs.
- Manage the identified engagement programs and execute on the cross-functional tactical responsibilities within the organization to achieve strategic goals.
- Support strategic priorities and initiatives to help manage messaging across Karyopharm’s external digital and social media channels.
- Partner with relevant stakeholders to create, develop and synthesize a consistent narrative and messaging plan across the organization related to how Karyopharm communicates with the oncology community including patients, advocates, physicians and other healthcare providers, biotech and pharmaceutical industry partners, media and other stakeholders.
- Support and execute on the Company strategy regarding communication with the media community, predominantly in the US, to shape educated and balanced media coverage for Karyopharm, our science and our programs.
- Support and align with disease awareness and patient-led campaigns (internal and external) for Karyopharm, in partnership with medical affairs.
- Manage a team of employees by utilizing best in class managerial approaches and modeling leadership competencies such as effective communication, managing execution, coaching & development, and engaging/inspiring.
We are seeking a Senior Director, Launch Excellence to serve as the lead for launch activities across the organization. This position will define and manage rigorous cross-functional processes and plans that enable Karyopharm to execute on critical product launches and company initiatives. In this highly visible role, you will partner with colleagues in R&D, Clinical, Marketing, Market Insights, Market Access, Sales, Finance, Legal, Regulatory, Supply Chain, Medical Affairs and other teams to program-manage launches, strategic campaigns, sales enablement initiatives, and other programs.
This position will create the Launch Center of Excellence for driving planning, execution, communication, tracking & measurement, and collaborations across the company.
- Lead the launch strategy initiatives, responsible for delivering the launch plans and preparing the organization to commercialize our products.
- Continually raise the bar across Karyopharm to make each launch better than the last.
- Benchmark biopharma and outside of pharma trends on launch best practices around preparation and execution. Bring cutting edge approaches into Karyopharm.
- Collaborate with colleagues to define detailed launch plans and lead cross-functional meetings, project tracking, and communications in support of launches; identify and escalate any issues to quickly solve
- Manage the planning, execution, , including timelines and deliverables – you will supercharge our outcomes by enhancing our internal communication and collaboration to ensure no details are missed
- Be a champion for Launch Readiness across the company. Energize and excite the organization on the importance of launch readiness and what we can achieve
- Define, track, and communicate dashboards and other tracking tools to ensure visibility and focus on performance against launch goals, and facilitate closed-loop improvement; you will champion a results orientation throughout the organization
- Identify and manage risks and dependencies, including the development of contingency plans; your proactive approach will help us navigate uncertainty and hit key goals
- Continually seek and act on opportunities to improve cross-functional collaboration and efficiency; your insights and initiative will amplify results
- Identify & communicate evolving needs from benchmarking and post-mortem activities to ensure continual process improvement.
- Collaborate extensively across functions (i.e. clinical, market planning, market access, regulatory, patient advocacy and finance) and with the executive leadership team to provide key insights and shape launch strategy.
- Provides cross functional leadership for launch strategy, including priorities, milestones, and key performance indicators (KPIs) and milestone monitoring.
- Ensure alignment and continuity between pre-commercial launch activities, commercial launch activities and post-launch activities.
- Effectively manage assigned budgets and applicable launch agencies, vendors, etc.
The Clinical Project Manager is responsible for the planning, implementation, execution, oversight and management of Independent Research (IR) studies per Global Medical Research (GMR) SOP(s). The incumbent may manage clinical outsourcing to vendors as needed. May author, review and approve various study related documents and plans. Identifies issues, interprets data, and suggests and implements solutions and mitigation as required. Responsible for the budgetary and enrollment forecasting and tracking of each assigned IRs and develops and oversees study timelines. Tracks compliance with contractual and protocol reporting requirements and escalates issues as appropriate per the relevant Karyopharm business plan/SOP.
- Represents and leads the study team to develop, execute and manage global IR programs in accordance with Karyopharm GMR’s goals, strategy, business plans and SOPs, in compliance Good Clinical Practices (GCP) and ICH Guidelines.
- Review and contribute to the content of Independent Research Review (IRC) Committee meetings, clinical study documents, posters, presentations and publications.
- Involved in the vetting on new IR proposals, investigators, and institutions
- Assist and independently train IR sponsors on their responsibilities and interactions with Karyopharm as an investigator and sponsor of IR.
- Responsible for IR budget discussions and forecasting, while acting as a liaison with the Finance Department
- Ensures the delivery of clinical trial supplies (drug supply, lab kits) in collaboration with the clinical supply team.
- Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.
- Manages clinical vendor activities to ensure quality and alignment with Karyopharm and regulatory requirements.
- Reviews, approves, tracks and ensures compliance with contractual reporting requirements across all IRs.
- Provides IR reference material for responses during regulatory inspections and NDA submission(s).
- Continually collaborates with cross functional teams on audit readiness plans and procedures.
- Reviews and monitors compliance with trial budgets and contracts with sponsors, Institutions, vendors, and investigative sites, as applicable.
- Performs budget negotiations with sites
- Evaluates site and study performance metrics against agreed upon budget, deliverables and timelines.
- Assists GMR/GMSA Director with IR budget in fiscal planning/forecasting
- Works with the Regulatory/PVG department to maintain an accurate summary of IR safety information (i.e. DSUR and IB updates)
- Oversees and monitors the management of clinical studies ensuring they are conducted in accordance with the approved study plans/contracts/protocols through regular investigator site /clinical vendor contact.
- Continuous broadening of knowledge of therapeutic areas, current medical practice and pharmaceutical regulations to ensure best practice across all activities.
- Works collaboratively with Medical Science Liaisons (MSLs) to ensure consistent strategic messaging to all active and prospective investigators
- Works collaboratively with cross-functional departmental teams such as drug safety, clinical research and development, and other relevant departments
- Attend relevant symposia, conferences and scientific meetings, as necessary.
- Up to 10 - 15% domestic and/or international travel may be required.
SUMMARY: The SVP, Strategy and Portfolio Management, will be responsible for providing strategic and analytic leadership across all areas of R&D pipeline strategy and management including identifying asset-level, research/early stage portfolio interactions and implications as well as highlighting gaps and making recommendations. The VP, Strategy and Management will provide pipeline and strategic expertise to all members of the R&D senior leadership team. Additionally, The SVP, Strategy and Portfolio Management will lead and manage a team of Program Leaders.
- The SVP, Strategy and Portfolio Management, will provide high level oversight, management and drive across the span of development from strategy formulation to execution of that strategy; this encompasses the entire process from preclinical research through registration.
- The Strategy and Portfolio Management team will coordinate between all internal/external stakeholders (e.g. Clin Ops, Medical, Pre-clinical, PIs, MSLs, Regulatory, Research, Drug supply, Publications as well as Investigators, Patient groups) to ensure alignment, operational efficiency and program success.
- Creates and supports a consistent, linked strategic framework across early and late stage assets to enable strategic decision-making—including strategic context setting, decision structuring, risk assessment, value profiles, governance preparation, etc.
- Provides direction on product development requirements to meet expectations of external customers and business stakeholders. Interacts with research and development, marketing, manufacturing, and regulatory departments and with external stakeholders.
- Provides strategic leadership and expertise with respect to decision making--providing real-time evaluation and identification of material events, critical analysis of problems and utilization of insights.
- Monitors pipeline progress and industry benchmarking data, identifies trends, risks and gaps and recommends specific strategies to enhance/optimize KPTI’s pipeline. Drives pipeline review events, processes and deliberations including scenario planning and trade-off decisions
- Partners directly with governance members and senior leaders to ensure preparation, implementation and follow-up of scientific and pipeline-related decisions and actions.
- Drives synchronization and harmonization of inputs, outputs and processes across R&D governance and other pipeline related forums with a goal of streamlining and enhancing stakeholder experience associated with the pipeline governance and evaluation/management process. Specific responsibilities include chairing of forums, agenda curation and executive communications.
- Responsible for project performance, risk management, administration, financial management and issue resolution for functional group
The Associate Medical Director/Medical Director, Pharmacovigilance (PV) will provide broad support of activities requiring medical safety input for assigned products, pre- and post-approval. He/she will support and/or lead periodic safety signaling reviews and meetings, as well as perform individual and aggregate case review. He/she will also participate, in varying degrees, on clinical teams/programs and other intra and/or inter-departmental activities and initiatives.
- Represent department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues.
- Provide timely and sound medical review of individual case safety reports from clinical trials or post-marketing sources as needed.
- Participate in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans.
- Participate in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports.
- Lead preparation and review of periodic reports (IND, Annual Safety, DSUR, PBRERs, CSR).
- Review and provide medical content, as needed, for key study-related documents, e.g. IB, ICF, IDMC Charter.
- Participate in departmental development activities including SOP and Work Instructions development.
- Provide guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective.
- Provide a contributory role in Partner /Affiliate agreements and interactions, as needed.
- As directed by the PV Head, assume primary responsibility/chair for the conduct of one or more Safety Team(s) for assigned products.
- Lead the regular review of safety data for assigned products for the identification of new safety signals, in accordance with signal detection practices.
- Provide Risk Management Strategy.
- Other activities, as needed or as requested by manager.
The Vice President, Clinical Operations will lead local & global Clinical 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 and at the highest quality. This person will oversee the clinical trial execution including site selection, patient recruitment, clinical study monitoring, and CROs oversight. In addition, this person will oversee the development of study documents, development of processes and SOPs and applicable infrastructure within Clinical Operations. They will play a leadership role internally and with external stakeholders.
- Responsible for strategically planning clinical trials, resourcing, and providing oversight and execution to achieve program objectives and high quality deliverables within established timelines and budgets
- Work globally to ensure consistency in study execution across study teams and ClinOps locations
- Lead and/or participate in the development and review of department policies, SOP’s and other control documents
- Implement processes and build and refine Clinical Operations department to successfully plan and conduct multiple clinical trials in early to late stage to achieve corporate objectives.
- Develop and implement resource management and trial metric tracking tools and establish performance goals by role
- Evaluate and monitor resources and develop resource allocation plan for all projects
- Develop and maintain systems for effectively managing service provider relationships
- Responsible for ensuring operational excellence in clinical stage programs by applying high industry standards, policies, systems, and processes across all trials
- Stay abreast of the latest developments in the fields of project management and clinical monitoring in drug development. Maintain and improve professional knowledge of technological advancements in project management and clinical monitoring
The VP Medical Sciences will serve as the primary medical lead for developing the strategy for development of Karyopharm assets across indications with cross-functional study teams on clinical trial strategy, design and execution. Along with this, the VP/SVP- Medical Sciences will support and build medical team/medical directors responsible for monitoring the assigned trials. This individual will work across the organization working with the PV, Regulatory, QA, Commercial, Medical Affairs and Clinical Operations.
- Provide strategic input to portfolio management and prioritization
- Serve as the key partner and contributor for the strategic planning, support early and translational development; and prepare specific strategic plans and initiatives.
- Closely collaborate with the Medical Director and Scientists in the development of new strategic options for assets in late development.
- 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
- Supports 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
The individual in this position will play a key role in educating clinical trial sites and clinical research associates on Karyopharm products, protocol requirements, and supportive care guidelines. Effective internal and external customer interactions will be the focal point of this position. This person will provide protocol education and support to internal stakeholders and external collaborators participating in Karyopharm-sponsored clinical trials. The Clinical Research Scientist (CRS) role is a position that is comprised of licensed registered nurses or licensed advanced practice providers (Nurse Practitioner, Physician Assistant). The CRS is responsible for monitoring patient data under the supervision of the medical monitor and focuses on outreach and educating clinical site contacts (research nurses, study coordinators, investigators) on Karyopharm products and protocols. The CRS serves as a resource to clinical sites by identifying emerging patient issues or educational needs of staff and implements training or outreach to fulfill knowledge gaps.
The CRS may also establish ongoing relationships with local and regional advocacy organizations and societies as assigned. This collaborative approach will serve to provide education and enhanced clinical care, and to build strategic relationships with key nurse opinion leaders.
- Support recruitment activities by reviewing screening data and confirming patient eligibility for Karyopharm-sponsored clinical trials
- Monitors patient data and communicate with site study teams to obtain updates on patient status or site education needs
- Provides site training and guidance on Karyopharm products and Karyopharm-sponsored clinical trials
- Resolves routine study questions from clinical trial sites in adherence to ICH GCP and the study protocol
- Oversees ongoing protocol operations to ensure study compliance and troubleshoots possible protocol violations
- Coordinates various activities to ensure proper and timely filing of serious adverse events, protocol deviations, amendments, annual reports, and other regulatory documents
- Prepares and/or reviews study-related materials and resources (e.g., Site Initiation training, , Case Report Forms )
- Maintains oversight of protocol implementation by reviewing progress reports from CROs, monitoring reports, and audit reports as needed
- Collaborates on study-specific materials for research participant education
- Manages site relationships to ensure positive interactions through routine site contact
- May visit off-site collaborative centers
- Work cross functionally to identify customer education needs
- Deliver disease state and protocol-specific educational presentations to nurses, physicians and other health care providers
- Partner with national, state and local nursing organizations to support education on assigned disease states.
- Develop relationships with key nurse opinion leaders.
- Attend and participate in internal/external meetings, training classes conventions/conferences, and other business-related activities
- Excellent organizational, creative and analytical problem solving, and influential skills are required. This individual must be flexible and adaptable to new and constant changing situations.
- Key position to lead teams to deliver strategic project(s) that span across multiple departments
- Manage cross-functional activities around aggressive timelines and escalate critical issues to the Executive Team
- Management and timely escalation of issues, risks and project change requests to ensure successful and on-time project delivery
- Contribute to process improvement initiatives as it relates to improving project delivery
- Lead key submission preparations for NDA, MAA, and other submissions as needed. Also lead response team for FDA information requests regarding NDA and MAA submissions.
- Establish a project strategy for each submission, managing prioritization of project activities and processes development to enable the team to meet aggressive timelines
- Help build and maintain high level submission timelines (IND, NDA, MAA, DSUR, IB, Protocols, etc.) to enable departments to view, manage, prioritize, and resource activities
- Collaborate with cross-functional teams to build and maintain submission content plans and project timelines
- Work with departmental leads to ensure optimal capacity and project planning, implementing systems-based project management processes where appropriate
- Provide leadership for project team by building and motivating team members to meet project goals and proactively address concerns by brainstorming and assessing potential solutions
- Drive, communicate and record key decisions and action items through meeting minutes, decision logs, and action item trackers
- Communicate project updates such as key milestones, deliverables, dependencies, risks and mitigation plans to executive and department leadership
- Create and maintain tracking tools, including project portals, dashboards and reports using Smartsheet
- Work with teams to procure adequate resources to achieve project objectives in planned timeframes
- Work with departmental leaders to advance areas which are highlighted for process improvements
- Delegate and oversee tasks and responsibilities to appropriate personnel
- Work creatively and analytically in a problem-solving environment demonstrating teamwork, innovation and excellence
The main responsibility is to independently author complex regulatory and safety documents ensuring the coordination and integration of scientific, clinical and regulatory input from cross functional team members.
- Specifically lead the writing of complex clinical documents (e.g. protocols, protocol amendments, phase II/III clinical study reports, high level summary documents), and certain non-clinical documents (e.g. initial Investigator’s Brochure and safety update reports).
- Organize and lead meetings with study team members to determine timelines and processes for the assigned regulatory documents.
- Ensure key messages within the document and across the program are clear and consistent.
- Adhere to Karyopharm style guide for formatting and usage.
- Manage documents through the review process (coordinating document review meetings, collate and reconcile comments from various functional groups) and the approval process.
- Provide guidance/solutions for medical writing processes, standards, and innovative initiatives.
- Contribute to generation and maintenance of templates and standard text for clinical documents
- Critically reviews project specific data, outputs and shell reports; organizes meetings to get team consensus on document planning and maintain decision trail.
- Provide quality review as necessary for clinical and regulatory documents.
- Provide document support as needed to Regulatory Affairs
- Provide training and guidance to other medical writers, offering scientific and operational mentorship and coaching in the design, planning, and execution of their assignments.
The Clinical Research Scientist (CRS) /Senior Clinical Research Scientist position serves a key role within the Clinical Development R&D team, reporting to the Head of Clinical Research Science/Senior Medical Director. The CRS works closely with the assigned study team(s) and medical director(s) to support the activities associated with one or more clinical studies. The CRS leads or co-leads a study or study activities. This position collaborates with clinical team members as well as with functions outside of clinical to provide high quality and timely deliverables. The CRS is responsible for achievement of personal goals which support study team, project team, and corporate goals.
- Lead or support assigned study level activities for 1 or more clinical studies with minimal supervision; may lead or co-lead a study
- Thorough understanding of assigned protocol and protocol requirements
- Understands work to be done; plans ahead
- Lead/Co-Lead or Support study start-up/conduct/close-out activities as applicable
- Preparation, storage, maintenance of clinical documents (TMF)
- Protocol development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments, and ensuring high quality final document)
- Perform medical monitoring duties, under the supervision of the medical director, depending on the qualifications and experience of the candidate. Should be appropriately trained and fully aware of all aspects of the drug under investigation and the requirements of the protocol, including any annexes and amendments. In order to function as a medical monitor, the candidate should have adequate medical, pharmaceutical, and/or scientific qualifications, and clinical trial experience.
- Review and validation of clinical study reports (CSRs); thorough understanding the connection between the data and the CSR
- Author/coordinate and review Regulatory Documents (e.g., IB, Briefing Books)
- Author/Review Informed Consent Forms (ICF); review/support finalization of regional and site ICFs as needed; ensure high quality, appropriate reading level text, and alignment with protocol)
- Planning of site and CRA training; including logistics, materials and presentation
- Country/site selection activities
- Collaboration with Clinical Operations for budget preparation, CRO scope of work, etc. (i.e., review and provide feedback on activities/instructions/deliverables related to study data, IVRS, central labs, patient reported outcomes)
- Study committee (e.g., DMC) activities such as charters, meetings, presentation preparation
- Investigator Meeting and SIV planning/facilitation/presentation
- Activities related to data generation and validation, including CRF creation, clinical data review, communication as needed to resolve data queries, draft/update/review data review plans, support Clinical Research Physician in data review (generation of reports, action plans, trend identification), etc)
- Identify, escalate current/active/future issues; propose and enact solutions
- Identify and liaise with external partners
- Present data/information to external investigators or study staff (e.g., SIV presentations)
- Lead the planning and preparations for external/stakeholder meetings (e.g., IMs)
- Provide guidance and scientific expertise within team, across department, and across functions
- Collaborate with study team members (Clinical, Clinical Operations, Data Management, Statistics, Drug Safety, IMSC, Regulatory Affairs, Translational Medicine and Project Management) to ensure that key milestones are met on time and with high quality
- May support clinical development planning (assist with analysis of data and review of literature to support future planning)
This position reports to the Head of Regulatory Writing and works with cross-functional team to develop regulatory documents. This position is a hands-on writing position.
- Works with the Regulatory Lead to develop the overall strategy of regulatory documents.
- Authors regulatory documents such as meeting requests, briefing books, responses to Agencies, Clinical Overviews (Module 2.5), etc.
- Leads kick-off meetings for creating regulatory documents.
- Leads and manages cross-functional teams to review drafts of documents.
- Leads roundtable discussions to help resolve comments from cross-functional team members.
- Ensures that documents adhere to ICH, FDA, EMA guidances.
- Ensures that documents are properly formatted.
- Coordinates the QC review of regulatory documents.
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.
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.
- Responsible 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
Karyopharm Therapeutics is an innovation-driven pharmaceutical company focused on the discovery, development, and commercialization of medicines with the goal of improving the lives of patients with cancer. We are seeking a career-minded Scientist - Analytical Chemistry to join our pharmaceutical development team.
Reporting into the Senior Director of Pharmaceutical Sciences, Analytical Chemistry, the Associate Scientist/Scientist will support analytical testing for multiple programs including on-going manufacturing, and release and stability of drug substance and drug product across all stages of development at CMOs and CROs.
- Review analytical release data to ensure all approved procedures were followed and all specifications were met for manufacturing.
- Review protocols, reports and data associated with stability, method validation and method transfer.
- Enter stability data into iStability and collaborate with the Quality team (Commercial Quality/IMP Quality) for review.
- Evaluate for trends and ensure data is analyzed to help understand degradation pathways and to help develop specifications.
- Assist with the management of the reference standards across all programs including review of protocols, data and CoAs generated.
- Assure that source data and information is maintained and traceable.
- Assist with CMC activities to support regulatory filings (IND, NDA, IMPD, MAA, CTA) for Karyopharm development programs.
- Work closely with other members of Pharmaceutical Sciences, the Quality Team (Commercial Quality/IMP Quality), and Regulatory to ensure the successful GMP manufacture of Karyopharm clinical candidates and their successful progression through development to government filings
- Support communication with external vendors via conference calls and/or emails, etc. as needed
- Assist with non-compliance events and change controls for manufacturing support and testing with the Quality team (Commercial Quality/IMP Quality) for all Karyopharm programs.
- Assist as an analytical subject matter expert for CMO/CRO audits.
The Senior Medical Director will serve as the primary medical lead for Karyopharm Independent Research studies. S/He will support and inform the IST strategy, support data analysis, support and review all publications, as well as support NDA activities as needed.
• Review and contribute to all company publications.
• Join the publications team to inform and support strategy
• Support all oral and poster presentations.
• Support NDA activities across the programs
• Review the IB and related regulatory documents
• Support commercial organization at Ad Boards and meeting with medical director support.
• Participates in independent research study calls, as needed
• Responsible for monthly review of safety queries and monthly reporting from independent research studies. The MD will be responsible for raising safety trends or issues on independent research programs to the executive leadership team and ensuring that the internal teams are aware of safety trends across the independent research portfolio
• MD is responsible for representing the independent research program at monthly safety signaling meetings
• MD will serve as the initial escalation point for patient related questions or concerns raised by independent research sponsors and investigators
• Collaborates with Medical Science Liason (MSL) and Clinical Project Manager (CPM) to ensure support for independent research studies
• Key stakeholder reviewer on all independent research protocols, amendments, and informed consent documents.
• Attend CME programs to understand new data and represent KPTI
• Leverage independent research data to inform the company sponsored trial (CST) strategy
• May serves as the medical director on collaborative research engagements, including large cooperative group studies and CTEP initiatives
• Responsible for understanding and presenting, in context, all independent research study data
• Sit on the review committee to evaluate all proposals
• Support the independent research strategy and be a key face for physicians to interact with for medical discussions
• Strong presentation skills, including ability to prepare comprehensive presentations, for internal and external use
• Work collaboratively, effectively, and efficiently with all internal functional groups