Serving as the medical lead for hematological malignancies in the planning and execution of clinical trials, conduct medical monitoring activities, support pharmacovigilance, and develop clinical content for regulatory submissions and interactions
Contributing strategic clinical input into clinical trial protocol development and tactical execution to assess the company's key compound in selected patient populations for new indications and/or new drug formulations
Acting as the primary clinical contact and subject matter expert on clinical programs, including communication and training with internal colleagues, as well as trial investigators and sites, and regulatory authorities as needed
Providing clinical input into interpretation and reporting of data, including review of pre-clinical package, clinical trial reports, investigators brochures, etc.
Maintaining a high level of clinical and scientific expertise in the disease area by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators, and internal stakeholder.
Developing and maintaining strong, collaborative cross-functional relationships with teams and key internal and external stakeholders, including developing, supporting, and moderating clinical advisory boards and drug safety monitoring boards
Supporting IST Program
Authoring manuscripts and collaborating with cross-functional colleagues and thought leaders to meet publication plan objectives
Observes high ethical standards and has demonstrated ability to comply with all relevant ethical, regulatory, and legal standards
Presents at scientific, medical, and regulatory meetings globally
Developing and maintaining relationships with academic investigators, pharmaceutical partners / sponsors, KOL's, patient advocacy groups, and others
You will rock this role if you bring:
MD or equivalent ex-US medical degree
2-3 years of experience developing strategy and execution of hematological tumor indications in a biotech or pharmaceutical setting
7-10 years clinical trial experience in an academic or industrial setting, with experience in analysis of research data and publications; working knowledge of biostatistics and pharmacokinetics; working knowledge of GCP, scientific and clinical research methods and clinical study design, regulatory requirements for clinical studies
Prior oncology research experience required
Pharmaceutical/Biotech industry experience, including time managing clinical trials and/or clinical development program mandatory
Excellent oral and written communication skills
Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate
10+ years clinical trial experience in an academic or industrial setting preferred, with experience in analysis of research data and publications
Prior experience treating patients in a specialty setting or equivalent preferred
Our Karyopharmers live and demonstrate our ICURE values every day!
Karyopharmers are passionately driven in our mission to positively impact patients' lives and defeat cancer! This is personal, and we approach every challenge fiercely and tenaciously, but with enthusiasm, empathy, and passion. The work we do is both inspiring and life-changing. It requires the most diverse, the most unique, and the most authentic team in the industry. We are 400+ cancer driven conquerors, across the globe, with a strong sense of our values and our purpose. We are innovators, disrupters, and collaborators, and we challenge the norm and do things differently. At Karyopharm you will have the opportunity to do well by doing good, while learning and growing along the way. We invite you to join us and make your own personal contribution to our mission!
What We Offer:
In addition to our exciting, supportive, and intellectually challenging global workspaces, Karyopharmers enjoy a comprehensive and generous benefits package that makes them more productive and contributes directly to the development of their professional skills.
A fun, collaborative, work environment
A culture of employee engagement, diversity, and inclusion
Competitive salary, bonus, and generous equity offerings - we are partners in prosperity!
Peace of mind through best in class medical , dental, vision, disability, and life insurance, parental leave, a matching 401k program , and tuition reimbursement.
Generous PTO and Holidays - we encourage you to recharge and spend time with family and friends.
Ample opportunities to learn and take on new responsibilities in a fast-paced, and patient focused company.
Cell phone allowance
*Karyopharm requires all employees to be fully vaccinated against the Covid19 virus at the time of employment
* This position is eligible for remote/hybrid working arrangement
WE ARE COMMITTED TO DE&I
Posted Date : 2022-05-07
Job type : Full Time