Medical Director

Role Overview & Key Functions:

The Medical Director will serve as the primary medical lead for Karyopharm study team within assigned clinical trials and with cross-functional 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 may work on multiple trials to include solid tumor(s), myeloma and other hematological studies.

Reporting to our Senior Medical Director, you will positively impact patient's lives 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), clinical study reports (CSR), and regulatory submission documents.
• Act as liaison between Clinical Development and other internal groups at Karyopharm (e.g., Regulatory Affairs, Clinical Operations, Clinical Data Management) for assigned studies.
• Participate in development of 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

Candidate Profile & Requirements:

• MD, DO or equivalent ex-US medical degree.
• 4+ 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;
• Completion of an Internship and/or Residency as a physician in oncology, hematology, internal medicine, or relevant medical specialty area.
• Cancer research experience
• Pharmaceutical/Biotech industry experience or Academic experience, including time managing clinical trials and/or clinical development program(s)
• Excellent oral and written communication skills
• Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate

At Karyopharm, base pay is one part of a competitive total rewards package that includes comprehensive benefits (medical, dental, vision, 401(k), and more), equity and the potential to receive annual target bonuses. Actual pay is based on factors such as location, experience, skills, education, and internal equity. We maintain broad salary ranges to reflect market conditions and the specialized nature of our work. The anticipated base salary range for this position is $270–$300k USD.

Our Value Proposition:

At Karyopharm, we live and demonstrate our ICARE values every day! If you want to do something that matters, this work matters. Patients drive our passion