Job details
Job type full-time
Full job description
Responsibilities: summary: the vice president, global medical and scientific affairs (hematology/oncology lead) will report to the svp head, global medical and scientific affairsHe/she will lead and provide scientific/medical leadership and support for compounds in various stages of clinical development, as well as approved products in the hematology/oncology therapeutic area.
This individual will be involved in integrated strategic planning within global medical and scientific affairs (gmsa) as well as with partners in the us commercial organization, clinical research and development, translational development, and market access, and will lead the us medical team for hematologic malignancies / solid tumors.
The vp will be responsible for the overall medical strategy in hematologic malignancies in alignment with overall us and global medical affairs strategy and will be responsible for execution of the medical plan for the therapeutic area (s).
He/she will represent gmsa in hematologic malignancies with broad responsibilities and impact across the us business and overall global medical and scientific affairs organization.
Provide scientific and strategic support for therapeutic assigned products; deliver scientific presentations; develop and maintain professional and credible relationships with key opinion leaders; actively participate in relevant cross functional brand teams, publication strategy, and helps develop medical affairs strategies for assigned products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training.
He/she will work closely with the global medical affairs team to support and prepare for the us launch of new products and label expansion.
Responsibilities:
Lead the development of medical affairs plans within the assigned hematology/oncology disease area.
Serve as the key resource within medical affairs and to cross-functional partners for disease area and portfolio assets as assigned.
Identify key national and regional oncology thought leaders and priority customers, lead the engagement strategy and build / maintain advocacy with top-tier individuals.
Work closely with field-based medical affairs staff (msls) and clinical research / operations teams, commercial/marketing (as appropriate) to coordinate engagement and communication.
Accumulate, synthesize, and provide actionable implications for key competitive information to aid the clinical and marketing teams in drug / brand development.
Develop key advocates as speakers to support karyopharm products and strategies.
Contribute scientific and clinical expertise to the development and execution of medical affairs training, commercial training, and customer educational activities.
Provide subject matter expertise for internal programs supporting commercial training and marketing efforts and professional services.
Represent global medical and scientific affairs as a therapeutic area expert in both internal and external venues including the clinical development group, advisory boards / steering committees and ensuring a high level of customer satisfaction and compliance.
Serves as the scientific team interface for key regulatory discussions
May assist in the development of scientifically accurate materials for medical engagement, medical programs, advisory boards, and symposia
Assists with the scientific review, development, approval, execution, and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities
Represent karyopharm at professional meetings, congresses, and local symposia, and being responsible for the overall medical and scientific direction and support to current commercialized products, as well as future pharmaceutical entities.
Strategic and tactical planning: responsibility for the medical affairs aspects of plans across hematologic malignancies, in alignment with global plans, and their timely updates.
Support team leads in the design, execution, and evaluation of clinical trials according to strategy and good clinical practice.
Drive execution of data generation efforts to support both inline and pipeline products through registries, digital health and intervention studies, e.gProvide oversight across the ist (investigator sponsored research) studies within the therapeutic area: provide accountability and support the sub-team leads in the integration of feedback from cross-functional reviewers, negotiation of budgets, review of protocols, and coordination of resources to support the investigators in timely opening, accrual, collection of data, and publication of results.
Provide the appropriate training, coaching, and accountability to ensure superior content, operational, presentation, leadership, and strategic skills for global medical and scientific affairs.
Provide oversight and ensure quality of disease-specific medical training within the therapeutic area for the msl team, sales team, and other functions, including disease state training and standard care training, competitive landscape training, training on karyopharm sponsored trials, including registration trials, and relevant manuscripts.
Interface effectively with all other karyopharm internal stakeholders: global medical affairs functions and other departments, including commercial, clinical research and development, regulatory affairs, managed care, pharmacovigilance, market access, statistics, translational research/development, project leadership, etc.
Qualifications:
Experience and understanding of oncology drug development.
Previous pharmaceutical industry experience required.
Prior medical affairs experience, minimum 5 years preferred.
Advanced degree in health-related field, md preferred with experience in hematology/oncology.
Knowledgeable of competitive products and their application.
Strong expertise in the conduct of clinical trials in hematology/oncology, with proficiency in critical data review and interpretation.
Product lifecycle management experience highly preferred.
Good understanding of medical affairs and comprehensive understanding of the compliance issues concerning ma function.
Support successful cross-functional and multi-disciplinary teams in changing competitive environment, changing product technology, and changing customer needs.
Excellent communication and organization skills, including presentations to large groups, facilitation of interactive discussions, and 1:1 scientific discussions with thought leaders.
Demonstrated customer focus orientation & credibility with customers.
Knowledge/application of data sources, reports and tools for the creation of solid plans.
Ability to successfully collaborate in a diverse work group, motivate and maximize productivity.
Excellent analytical, communication and presentation skills and solid experience in translating medical/clinical information into medical affairs strategies.
Ability to think strategically, good leadership skills, efficiently manage time and priorities, and able to work in a fast-paced, ever-changing environment.
Collaborative mindset, good communication skills
Travel requirement; approximately 20% (including international)
Overview:
Karyopharm therapeutics inc(nasdaq: kpti) is a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development, and commercialization of first-in-class drugs directed against nuclear export for the treatment of cancer and other diseasesKaryopharm`s selective inhibitor of nuclear export (sine) compounds function by binding with and inhibiting the nuclear export protein xpo1 (or crm1)Karyopharm`s lead compound, xpovio® (selinexor), is approved in the u.sIn multiple hematologic malignancy indications, including in combination with velcade® (bortezomib) and dexamethasone for the treatment of adult patients with multiple myeloma after at least one prior therapy, in combination with dexamethasone for the treatment of adult patients with heavily pretreated multiple myeloma and as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphomaNexpovio® (selinexor) has also been granted conditional marketing authorization in combination with dexamethasone for adult patients with heavily pretreated multiple myeloma by the european commissionIn addition to single-agent and combination activity against a variety of human cancers, sine compounds have also shown biological activity in models of neurodegeneration, inflammation, autoimmune disease, certain viruses and wound-healingKaryopharm has several investigational programs in clinical or preclinical developmentFor more information, please visit www.karyopharm.com.
Karyopharm therapeutics inc(the `company`) is an equal opportunity employerAll 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 lawConsistent with its obligations under applicable law, the company will make reasonable accommodations for qualified individuals with disabilitiesIf you require an accommodation in the application process, please contact a member of the company’s human resources department.
