Medical Director

Karyopharm Therapeutics Inc.; United States; Remote; USD 270,000 - 300,000; Full time

Job summary

Karyopharm Therapeutics is seeking a Medical Director to lead clinical trials and maintain safety oversight. This role involves participation in regulatory submissions and development of key study documents, requiring an MD or equivalent and significant clinical trial experience. The position offers a competitive salary and comprehensive benefits.

Benefits

Comprehensive benefits package

Generous PTO and Holidays

Wellness Program with monthly stipend

Qualifications

• 4+ years clinical trial experience in an academic or industrial setting.
• Working knowledge of GCP, scientific and clinical research methods.
• Cancer research experience preferred.

Responsibilities

• Serve as primary medical lead for clinical trials.
• Monitor the safety of enrolled subjects.
• Participate in the development of study protocols and regulatory documents.

Skills

Oral communication

Written communication

Team collaboration

Education

MD, DO or equivalent ex-US medical degree

Completion of an Internship and/or Residency

Job description

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 to pioneernovel cancer therapies.That’s why we’ve built an environment centered around support, flexibility, and a shared mission.

Creating and delivering medicine for cancer can only be done through focus, dedication, and heart.We hire exceptional peopleand trust each other to work in whatever way lets us, be us – whether that’s onsite, from home, or anywhere in between.

What do you get when you pair an extraordinary mission with a culture of flexibility and empowerment?We invite you to find out and join us on this incredible mission.

Check out our Culture Video!

What We Offer:

In addition to our exciting, supportive, and intellectually challenging global workspaces(s), team members enjoy a comprehensive and generous benefits package (active on day one) that makes them more productive and contributes directly to the development of their professional skills.

• A culture of employee engagement, diversity, and inclusion
• Competitive salary, bonus, and generous equity offerings (RSU’s at time of offer and annual awards) – we are partners in prosperity!
• Peace of mind through best in class medical (deducible paid by KPTI), dental, vision, disability, and life insurance, parental leave, a matching 401k program (immediate vesting), ESPP and tuition reimbursement.
• Wellness Program with a monthly stipend.
• 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. (tuition reimbursement, management development & mentoring programs, and a variety of reward and recognition programs)
• Cell phone allowance