Position: Medical Director/Senior Medical Director, Pharmacovigilance
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 Medical Director, Pharmacovigilance (PV) will report to PV Head. He/she will provide broad support of activities requiring medical safety input for assigned products, pre- and post-approval. He/she will support and/or lead periodic safety signaling reviews and meetings, as well as perform individual and aggregate case review. He/she will also participate, in varying degrees, on clinical teams/programs and other intra and/or inter-departmental activities and initiatives.
- Represent department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues.
- Provide timely and sound medical review of individual case safety reports from clinical trials or post-marketing sources as needed.
- Participate in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans.
- Participate in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports.
- Contribute to preparation and review of periodic reports (IND, Annual Safety, DSUR, PSURs, CSR).
- Review and provide medical content, as needed, for key study-related documents, e.g. IB, ICF, IDMC Charter.
- Participate in departmental development activities including SOP and Work Instructions development.
- Provide guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective.
- Provide a contributory role in Partner /Affiliate agreements and interactions, as needed.
- As directed by the PV Head, assume primary responsibility/chair for the conduct of one or more Safety Team(s) for assigned products.
- Participate in the regular review of safety data for assigned products for the identification of new safety signals, in accordance with signal detection practices.
- Participate in Risk Management Strategy.
- Other activities, as needed or as requested by manager.
- MD, DO or equivalent.
- Minimum of 6-8 years Drug Safety/Pharmacovigilance or Medical Monitor experience.
- Solid knowledge of General Medicine, MD, DO, MBBS.
- Adequate knowledge of GCP, ICH and Global regulations.
- Prior NDA experience and oncology experience preferred.
- Experienced in the evaluation and interpretation of data.
- Ability to multi-task.
- Solid written and oral communication skills.
- Solid judgment and decision-making skills, including the identification and communication of relevant safety- related issues or concerns to Medical Safety Management in an appropriate and timely manner.
- Experienced in safety reviews of AEs/SAEs, IBs, protocols, clinical study reports, informed consents, and other safety-related documents.
- Close attention to detail.
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