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Medical Director/Senior Medical Director, Clinical Development

Company: Karyopharm Therapeutics Inc.
Location: Newton
Posted on: September 12, 2020

Job Description:

Karyopharm Therapeutics Inc. Medical Director/Senior Medical Director, Clinical Development in Newton , Massachusetts The Medical Director/Senior 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.

Participates 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.

Serves on cross-functional teams for assigned trials, working with other team members to achieve efficient, high-quality study execution.

Participates 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.

Provides 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.

Develop 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

Support IST Program

Partner with pharmacovigilance to assess the safety profile of compounds

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

As required by program needs, contribute in partnership with Discovery colleagues to the design and implementation of translational strategies

Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule

Present at scientific, medical and regulatory meetings globally

Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOL’s, and patient advocacy groups

Contribute to activities in support of the company’s planned NDA submissions. Author clinical sections for INDs, NDAs, and other related documents

MD, DO or equivalent ex-US medical degree.

5-10 years clinical research 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;

Pharmaceutical/Biotech industry 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

Karyopharm Therapeutics is a global commercial-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.

Karyopharm Therapeutics Inc. (the "Company") is an equal opportunity employer. All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law. Consistent with its obligations under applicable law, the Company will make reasonable accommodations for qualified individuals with disabilities. If you require an accommodation in the application process, please contact a member of the Company’s Human Resources department.

USA Cares exists to help bear the burdens of service by providing post-9/11 military families with financial and advocacy support in their time of need.

USA Cares is a national 501(c)(3) non-profit, charitable organization based in Kentucky and registered with the IRS.

Keywords: Karyopharm Therapeutics Inc., Newton , Medical Director/Senior Medical Director, Clinical Development, Other , Newton, Massachusetts

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