Position: Senior Director Clinical Pharmacology
Karyopharm Therapeutics is a clinical-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.
The Senior Director, Clinical Pharmacology will have a pivotal role in providing strategic nonclinical and clinical pharmacology guidance on our drug development, including PK/ADME, drug interaction studies, pharmacodynamics, and population PK. The candidate will possess strong writing capabilities, able to contribute to briefing documents for regulatory agencies, INDs and NDAs. The candidate will bring extensive experience in oncology, quantitative pharmacology (both clinical and non-clinical experience), and work cross-functionally to achieve department and corporate goals. Karyopharm is a fast-paced interactive science driven work environment.
- Work closely will cross functional teams and is the subject matter expert in quantitative clinical pharmacology with additional experience in non-clinical pharmacology
- Contribute to program strategy, study design, protocol preparation, study execution, data review/analysis, report and regulatory document preparation.
- Review literature and peer-reviewed publications to keep apprised of global regulatory developments, including guidance and recommendations, in clinical pharmacology
- Manage and be accountable for pharmacokinetic, ADME, drug interaction and pharmacodynamic data from for all nonclinical and clinical trials.
- Oversee program progression including protocol conduct, data analysis, internal decision points and external regulatory interactions
- Represent nonclinical and clinical pharmacology during meetings and discussions with regulatory authorities
- Create or guide nonclinical and clinical pharmacology summary documents
- Maintain a high standard for good laboratory and clinical practices, compliance, and ethics
- Act collaboratively, with constant exchange of ideas, to advance innovation
- PhD with at least 10 years of relevant nonclinical and clinical pharmacology experience supporting early and late-stage drug development and IND, NDA, BLA and MAA applications within the pharmaceutical and biotechnology industry
- Demonstrated experience in writing, presenting, and discussing nonclinical and clinical pharmacology with both internal and external stakeholders, including regulatory authorities
- Strong analytical skills and ability to interpret complex nonclinical and clinical data sets
- Proven ability to engage in discourse involving innovative drug discovery
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