Head of Pharmacovigilance
Nimbus has an outstanding opportunity for a Head of Pharmacovigilance to join our growing team. In this role, you will lead and develop the Pharmacovigilance function in accordance with Nimbus’ global portfolio by serving as the subject matter expert for all medical and operational PV safety activities. This role requires an individual with a strong track record leading Benefit-Risk assessments for complex investigational compounds. You will report to the Chief Medical Officer.
In this role, you will:
- Strategically lead Nimbus’ Pharmacovigilance & Drug Safety function and ensure function is an integrated component of Nimbus’ development organization
- Responsible for drug safety talent: employees, contractors, consultants, and CROs to ensure a compliant Drug Safety department
- Manage internal employees and external contractors to ensure delivery of quality drug
- Oversee and direct all aspects of global pharmacovigilance & risk management activities for investigational compounds; actively participate in oversight of patient safety in all clinical trials
- Provide a clinical safety view into preclinical / discovery programs in the pipeline
- Oversee the development and maintenance of signal management, safety surveillance and risk management plans for current and future drug development programs
- Serve as the Company’s Subject Matter Expert for all strategic safety related material including providing leadership and guidance for all relevant regulatory authority safety related questions, audits, and inspections
- Ensure expert safety review and leadership of critical development program documents including protocols, ICFs, IBs, IMPDs, CSRs, INDs, CTAs, and NDA/MAA submissions.
- Provide medical review of ICSRs to ensure the accuracy and completeness of AE and SAE cases
- Direct the development, preparation, and compliance of periodic and annual safety reports
- Coordinate the development of departmental policies & SOPs (Standard Operating Procedures) that address that address the processing, analysis and reporting of safety information to ensure proactive surveillance of products in development
- Monitor industry best practices and update current global safety regulations and guidelines for investigational and marketed projects to ensure a compliant Drug Safety department
- Coordinate to ensure training of appropriate personnel and external groups of Pharmacovigilance principles, policies, and SOPs
- Manage the process of identifying, evaluating, and selecting outsourcing vendors.
- Ensures 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
- Provide ad/hoc PV support & guidance for interdepartmental and/or corporate initiatives as needed
These qualifications will help this role be successful:
- Medical degree (MD or MBBS) with a minimum of 10+ years pharmacovigilance experience within the pharmaceutical or biotechnology industry
- Experience leading medical safety profiles for developmental products, preferably within Oncology and/or Immunology
- Previous experience managing a Pharmacovigilance team
- Oversight experience of company-wide medical safety activities, operational and risk management strategies in pre-marketing environments
- 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 Safety reporting and processing for clinical trial environments
- Ability to exercise sound clinical judgment and communicate complex clinical issues in a scientifically sound and understandable way
- Strong knowledge of common safety databases (Argus, ARISg, etc.)
- Excellent verbal and written communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teams
A Snapshot of Nimbus
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.
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.
Founded in 2009, Nimbus is a private, growing biotechnology company headquartered in Cambridge, Massachusetts. Learn more about us by going to www.nimbustx.com
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.