Medical Director, Clinical Development - Myelofibrosis

Full Time Remote in United States Medical Affairs Medical Director Clinical Development Apply for this Job 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 in Phases 1 through 3.

Reporting to our Vice President, Mead 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.
• 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 INDs and CTAs, 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).
• Acts as liaison between Clinical Development and other internal groups at Karyopharm (e.g., Regulatory Affairs, Clinical Operations, Clinical Data Management) for assigned studies.
• Represent Karyopharm to outside medical personnel in the development of clinical protocols and study conduct.
• Respond to site and Health Authority questions about protocols
• Conduct monthly review of data listings and lab data. Attend monthly safety meetings
• Review daily lab alerts and SAEs. Communicate with CRO/safety team/sites regarding follow-up.
• Attend and present at Investigator meetings
• Design and implement monitoring plans
• DBL (final listing review, review of blinded TLF, review protocol deviations, participate in all DBL meetings)
• CSR writing (review final TLFs, work with medical writers to review & revise CSR documents, draft discussion, and conclusions, participate in comment resolution meetings)

Qualifications

• MD, DO, or equivalent ex-US medical degree (non-MD candidates with doctoral degrees may be considered with appropriate background in a clinical field).
• Prior experience with Phase III oncology studies.
• Minimum of 3 years of clinical research experience in an academic or industrial setting, with experience in analyses 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
• Detail-oriented and Excellent oral and written communication skills
• Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate