Overview
Medical Director role at Karyopharm Therapeutics Inc.. The Medical Director will serve as the primary medical lead for Karyopharm study teams within assigned clinical trials and with cross-functional teams on clinical trial strategy, design and execution. In addition, 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 including 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 sections 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), 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 address 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 interactions with consultants, thought leaders, investigators and internal stakeholders.
* 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 activities.
* Present at scientific, medical and regulatory meetings globally.
* Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOLs, 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.
Compensation & Benefits
At Karyopharm, base pay is one part of a comprehensive rewards package that includes medical, dental, vision, 401(k), equity, and the potential to receive annual target bonuses. Actual pay is based on location, experience, skills, education, and internal equity. The anticipated base salary range for this position is $270–$300k USD.
Our Values
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 to pioneer novel cancer therapies. We\u2019ve built an environment centered around support, flexibility, and a shared mission. We hire exceptional people and trust each other to work in whatever way lets us be us onsite, from home, or anywhere in between. We invite you to find out and join us on this incredible mission.
What We Offer
* A culture of employee engagement, diversity, and inclusion
* Competitive salary, bonus, and equity offerings (RSUs at time of offer and annual awards)
* Extensive medical benefits, including medical, dental, vision, disability, and life insurance; parental leave; a matching 401(k) program (immediate vesting); ESPP; and tuition reimbursement.
* Wellness Program with a monthly stipend.
* Generous PTO and holidays.
* Opportunities to learn and take on new responsibilities in a fast-paced, patient-focused company.
* Cell phone allowance.
Job Details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Health Care Provider
* Industries: Pharmaceutical Manufacturing
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