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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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The Site Relationship and Recruitment Lead is a pivotal role within our Clinical Operations team, responsible for establishing and nurturing strong relationships with research sites and overseeing the engagement and recruitment strategies for clinical trials. This role requires a proactive and detail-oriented professional with exceptional interpersonal skills and a deep understanding of clinical research processes
Reporting to the Associate Director of Field Excellence, you will positively impact patients’ when you:
- Develop site engagement tools and strategies to drive site recruitment across assigned study(ies)
- Partner with clinical study team and Global Medical and Scientific Affairs (GMSA), when applicable, to develop study and/or program level site engagement and recruitment plans (SERPs) and additional strategies to deploy to the field team.
- In collaboration with assigned sites, develop site specific engagement and recruitment plans, and discuss site recruitment strategies and tactics to meet study goals.
- Partner with clinical trial sites, CRO, alliance partners and GMSA, when appropriate, to maintain SERPs and drive implemented strategies.
- Maintain regular and proactive communication with sites to address site recruitment strategy delays, issues and concerns.
- Communicate enrollment expectations to sites, address concerns, barriers and escalate to appropriate stakeholders for resolution.
- Ensure that recruitment strategies with sites adhere to all relevant regulations, guidelines, and ICH/GCP standards.
- Leverage lessons learned to course correct and adjust site engagement strategies as needed.
- Communicate with clinical operations team, medical, and other internal/external stakeholders to share barriers and insights related to site recruitment and retention and propose mitigations to address.
- Partner with the clinical operations team and medical to optimize site communication strategies that impact site engagement and recruitment.
- Maintain thorough knowledge of disease state, compound and protocols to optimize site relationship and engagement.
- Ensure accurate and up-to-date records of site interactions, recruitment activities, and progress towards enrollment goals.
- Provide regular updates on study site recruitment status, plans to address any noted barriers and potential areas for improvement. In addition, confirm that engagement and recruitment strategies are effective at meeting study goals with an ability to shift as needed.
- May participate in cross-functional initiatives to support business execution.
The 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 myeloma and hematological other studies.
Reporting to the SVP Medical Lead, you will positively impact patients’ when you:
- Participate 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.
- Serve on cross-functional teams for assigned trials, working with other team members to achieve efficient, high-quality study execution.
- Participate 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.
- Provide 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).
- Act 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
- 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
- Present at scientific, medical and regulatory meetings globally
- Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOL’s, and patient advocacy groups
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. This individual 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.
This position will provide geographical coverage for Manhattan, Long Island and Hackensack NJ.
Reporting to the Field Medical VP, you will positively impact patients’ when you:
- Identify and develops creative, innovative approaches for external engagement
- Partner with leadership to develop strategies that will adapt medical affairs to the evolving external environment
- Understand oncology treatment paradigms, key stakeholders, and healthcare landscape within the designated coverage area (regionally and/or locally) and within assigned institutions.
- Identify disease concepts and compound characteristics that can be leveraged into product differentiation
- Represent 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.
- Identify and engage key KOLs, HCPs, and investigators in scientific exchange on disease landscape & Karyopharm’s assets.
- Serve as a key member of the Karyopharm GMSA team to share actionable insights/learnings to help inform and develop the medical strategy.
- Collaborate 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.
- Provide support for congress meetings, including scientific coverage, competitive intelligence, medical booth staffing and external engagements.
- Deliver medical/scientific presentations to internal & external stakeholders.
- Respond to external inquiries and deliver appropriate clinical and scientific information
- Document field engagements and contributes to aggregate reporting of the Field Medical Team activities and value to the company.
- Respond to external inquiries and deliver appropriate clinical and scientific information
- Represent Karyopharm at select scientific congresses and professional society meetings
- Travels to meetings, face-to-face engagements, as required, estimated at 60%.
Reporting to the Director, GCP/GPVP, you will positively impact patients’ when you:
- Act as a strategic compliance partner to provide support and guidance on the interpretation of GCP regulations and industry best practices to internal and external stakeholders.
- Support inspection readiness activities and participate during regulatory inspections.
- Assist in the design and implementation of risk-based audit strategies which may include but are not limited to clinical investigator audits and vendor audits.
- Partner with cross-functional departments and stakeholders to enhance Karyopharm's culture of quality.
- Provide Quality input on relevant clinical and non-clinical documents.
- Support other quality management efforts, as assigned.
- Support administrative activities such as tracking, trending, and generation of metrics.
- Contribute to the development of departmental policies, procedures, and guidelines.
- Apply emerging knowledge of clinical research to assist with recommendations and direction to clinical research teams to ensure compliance.
- Assist in the conduct of meetings to disseminate Quality and Clinical Compliance GCP findings.
- Assist in resolving clinical research non-compliance through root cause analysis, and corrective and preventative action plans.
- Support development, maintenance, and implementation an annual GxP audit plan in coordination with leadership with all GxP functional areas
- Manage contracts with providers of contracted GxP auditing services and carefully manage associated budgets; oversee assignment of audits to contracted auditors for the timely completion of audit plans
- Select, train, and oversee external auditors; monitor auditor performance and maintain external auditor training curriculum, records, CVs, etc.
- Work with the business leads to oversee the development of audit agendas designed to effectively asses auditee risk areas
- Lead internal GxP audits; provide training/direction to support auditors to facilitate internal audit capabilities within Karyopharm
- Lead high-priority external GxP audits and due diligence assessments as needed
- Schedule audits with external auditors per audit plan
- Schedule and facilitate pre-/post-audit meetings w/key stakeholders; manage completion of action items
- Assure audit project folders are prepared/maintained in Egnyte and manage access for designated users
- Evaluate and escalate potential critical observations and/or potential Unsatisfactory audit outcomes from contract auditors; prepare summary of available facts and initial analysis for senior management review
- Review audit reports to ensure they are clear and cover the most important information to support efficient development of meaningful CAPAs; confirm accuracy of standards cited and factual support for observations to justify classifications & ratings
- Prepare audit performance metrics to assure audit program is conducted per standards and SOPs
- Perform audit trending of audit findings to assist QA and organization in identifying potential risks and supporting continuous improvement
- Assure all audit plans, reports, CAPAs and certificates are appropriately archived
- Support supplier qualification activities including review of questionnaires and vendor approvals
- Evaluate Audit and Inspection Program processes for continuous improvement opportunities
- Support Karyopharm GxP Quality System projects, programs and functional area initiatives as required
- Support ongoing inspection readiness activities
- Up to 10% domestic and international travel required (for audit performance)