- Responsible for safety surveillance and risk management activities including, but not limited to medical review of ICSRs, routine review of safety data, and pertinent scientific literature articles. Contribute to the review of assessments for safety signals or in response to Regulatory Authority requests.
- Acquire and contribute knowledge of relevant drug class and/or competitor safety issues. Lead the development of safety surveillance strategy, identify potential clinical safety issues, and recommend appropriate risk mitigation measures.
- Establish and maintain collaborative working relationships with all key stakeholders (e.g., clinical study teams, safety CROs, business partners) which require expert contribution to the development of the product safety strategy.
- Conduct risk management activities including preparation and maintenance of relevant sections of clinical trial protocols, IBs (including the reference safety information section), ICFs, DSURs, RMPs, CCDS, and labelling, as required.
- Contribute to regulatory authority submissions (Investigational New Drug applications, New Drug Applications, Marketing Authorization Applications, etc.).
- Accountable for the safety components of study reports (i.e., CSRs), aggregate reports, and other regulatory documents.
- Consistently comply with all governing laws, regulations, RevMed standard operating procedures (SOPs) and other guidelines.
- 5 or more years of drug development experience in the pharmaceutical or related industry, of which at least 2 years include prior Safety Science experience, which include performance of medical review, safety surveillance/signal detection, and other related risk management activities.
- The ability to demonstrate a broad understanding of safety risk management (e.g., via demonstrable knowledge of the application of GVP, GCP, and CTR requirements)
- A relevant postgraduate qualification (e.g., MD, PharmD, PhD/MSc in a Life sciences discipline, or other post-graduate health professional qualifications).
- Proven success in creating and sustaining strong relationships with internal and external business partners across an organization to create positive partnerships.
- Demonstrated ability to lead and influence, with and without authority, in a global matrix environment.
- Evidence of proactive, structured thinking with the ability to rapidly respond to an evolving and complex environment.
- Apply complex data analysis / statistical methods to evaluate, interpret and present scientific data with clarity.
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Director, Medical Safety Science - Redwood City, United States - Third Rock Ventures
Description
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.
The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies.
As a new member of the Revolution Medicines team, you will join other outstanding scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity
The Director, Medical Safety Science provides safety science and pharmacovigilance support to all products across the RevMed portfolio, which includes early and late phase development activities as a member of the Medical Safety team.
The individual will be responsible for safety oversight and input into all aspects of study management across the portfolio, which includes review and authoring of clinical trial protocols, IBs, ICFs, and DSURs.
Additional safety related activities will involve medical review of individual case safety reports (ICSRs), safety surveillance of assigned products and implementation of appropriate risk mitigation and management activities.
The Director, Medical Safety Science will develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as an understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action, etc.).
Specifically, you will be responsible for:
Required Experience, Skills, and Education:
Preferred:
Given that these essential functions of the role must be performed on-site, this position requires full COVID-19 vaccination, subject to applicable law.
The expected salary range for this role is $195,000 to $260,000.An individual's position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics.
Base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
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