Medical Director/Senior Medical Director, Global Safety
Our client is a biotherapeutics company. They have asked us to assist them in a search for a Medical Director/Senior Medical Director, Global Safety.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Oversees safety management teams and ensures a thorough and consistent approach to the review of safety data.
- Ensures timely production of aggregate reports and responds to queries from Health Authorities.
- Actively participates in the Continuous Improvement Process (CIP) targeted at continuous improvements of quality of processes, methods, and communication.
- Reviews and contributes to safety relevant SOP and improvement of safety relevant SOPs.
- Handles responses to Regulatory Agency requests relating to patient safety.
- Ensures Corrective Action Plans are implemented efficiently and effectively when required.
- Sets safety strategy based on safety experience that allows for successful IND/NDA and initiation of first in human studies.
- Oversees all processes that lead to the production of safety sections and content of relevant clinical trial documents.
- Oversees development of core safety information for new products. Sets the strategy, reviews, and approves key filing documents.
- Provides major contributions to current and potential safety issues, being proactive in addressing safety issues and setting up any additional systems to mitigate risk.
- Give guidance on various medical, product-related, and process-related matters across departments and functions.
- Provides medical/scientific with regards to the selection of potential product acquisitions.
- Ensures additions to the portfolio have a promising benefit-risk profile based upon medical and scientific evaluation.
- Trains and acts as a mentor of Junior levels in the organization.
- A Medical degree plus accredited residency is required.
- Requires at least two years of working experience as a physician in patient care.
- Must have ten years of pharmaceutical/biotechnology industry experience, of which at least five should be in a safety role.
- Requires experience in addressing and managing complex safety issues in the pre-approval and post-approval environment.
- Must understand data capture, data management and statistical methods for the preparation and analysis of safety data in clinical trials.
- Requires the ability to independently perform qualitative and structured benefit-risk assessments for own products and across the therapeutic area portfolio.
- Must be able to select the appropriate key benefits and risks, build a value tree and articulate other important elements such as uncertainty, unmet medical need, and alternative treatment options.
- Requires the ability to apply analytical skills, knowledge about tools and approaches to collect, critically appraise and integrate information from all relevant sources for benefit-risk management.
- Must understand the business environment of a pharmaceutical company and how safety decisions can impact other functions and patients.
- The knowledge of PV documents and safety sections of documents is required.
- Requires the knowledge of safety sections/required safety contributions to regulatory submission documents.
- Must be able to convey complex concepts through clear and concise messages.
- Requires the ability to adapt leadership style to different situations, individuals, and cultural differences.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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