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Senior Director, Pharmacovigilance
3 months ago
Nimbus has an outstanding opportunity for an exceptional Senior Director of Pharmacovigilance to join our team. This physician leader shall have strategic and hands-on responsibility for clinical drug safety, particular within the therapeutic area of Oncology. Broad drug safety experience with small organic molecules is required to ensure monitoring, execution, and management of all pharmacovigilance and safety/risk assessments.
In This Role You Will:
- Perform pharmacovigilance (PV) & risk/safety management activities for Oncology and Immunology investigational small organic compounds, ensuring patient safety in all clinical trials
- Develop and maintain signal management, safety surveillance and risk management plans for current and future drug development programs
- Provide medical review of ICSRS and therapeutic expertise into AE and SAE cases
- Author, develop and prepare periodic and annual safety reports
- Ensure expert safety review of critical program documents including protocols, ICFs, IBs, IMPDs, CSRs, INDs, CTAs, and NDA submissions
- Provide a clinical safety view into nonclinical / discovery programs in the pipeline
- Serve as the company's subject matter expert for all strategic safety related material, including input and guidance for relevant authority safety related questions, audits, and inspections; provide ad/hoc PV support & guidance for interdepartmental initiatives
- Ensure compliance with all applicable laws and regulations and as appropriate, local, and foreign regulatory reporting requirements, for the processing and reporting of adverse events in coordination with Regulatory Affairs
- Monitor industry best practices and update current global safety regulations and guidelines to ensure compliance
- Contribute to the strategic development and execution of corporate initiatives, specific Business Development activities, and various organizational initiatives in Clinical Development
These Qualifications Will Help This Role Be Successful:
- Medical degree (MD or MBBS) with 8+ years pharmacovigilance experience within the biopharmaceutical industry
- Significant experience leading medical safety profiles for developmental Oncology compounds. Immuno-Oncology and/or Immunology experience preferred but not required
- Thorough knowledge of pharmaceutical/biopharmaceutical industry, especially clinical research and global regulatory requirements, and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities
- Demonstrated knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Drug Safety reporting and processing for clinical trial environments
- Ability to exercise sound clinical judgment and communicate scientifically complex clinical issues/events clearly
- Excellent verbal and written communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teams
- Ability to navigate, problem-solve, execute, and lead in a dynamic, fast-paced, and evolving environment
A Snapshot of Nimbus
Our Science
At Nimbus, we design breakthrough medicines. Utilizing our powerful structure-based drug discovery engine, we create potent and selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and which have proven difficult for other drug makers to tackle. With a decade-plus track record of success, we've built a world-class team in both computationally driven drug discovery and early clinical development while continuing to move the needle for patients.
Our Culture
Nimbus is a close-knit company (our employees are Nimbi, if you are curious) that values a fast-paced, entrepreneurial, intellectual-stimulating, and collaborative environment. We live by our Core Values: Integrity, a Passion for Excellence, Teamwork, and Authentic Communication and strive to build a community where we bring out the best in each other professionally and personally.
Our Company
Founded in 2009, Nimbus is a private, growing biotechnology company headquartered in Boston, Massachusetts. Learn more about us by going to
Join Nimbus. We are making a difference and you can too.
At Nimbus, we believe our diversity of backgrounds and experiences strengthens our community and our ability to design breakthrough medicines. We prioritize creating an inclusive, welcoming culture that promotes our core values and encourages every Nimbi to bring their whole selves to their work. Nimbus is proud to be an equal opportunity employer. We value and celebrate all our employees and recognize that our diversity and inclusion are keys to our success. Nimbus is committed to providing equal opportunity for all employees and applicants without regard to race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Nimbus does not accept unsolicited resumes from any source other than directly from candidates.
