Safety Physician

Company Description:

Molecular Templates is a clinical stage biopharmaceutical company focused on the discovery and development of differentiated, targeted, biologic therapeutics for cancer. We believe our proprietary biologic drug platform technology, referred to as engineered toxin bodies, or ETBs, provides a differentiated mechanism of action that may address some of the limitations associated with currently available cancer therapeutics. ETBs utilize a genetically engineered form of Shiga-like Toxin A subunit, or SLTA, a ribosome inactivating bacterial protein, that can be targeted to specifically destroy cancer cells. Additional information about Molecular Templates can be obtained at www.mtem.com.

Position Overview:

Molecular Templates is seeking an accomplished and highly motivated physician safety expert to manage Pharmacovigilance responsibilities for all investigational products. Required capabilities include intimate knowledge of safety, ability to generate correlations with pre-clinical data, understanding of biomarkers associated with safety, and monitoring of any emerging safety concerns and risk/benefit profile for 'own' compounds with input for other compounds as needed. The Safety Physician will be responsible for leading the safety surveillance and risk management of the assigned compounds and for managing patient safety and meeting regulatory reporting requirements.

Job Responsibilities will include:

• Function as pharmacovigilance representative/safety scientist and provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational products
• Perform medical case review of serious adverse event reports and patient narrative, including review of source documentation as needed
• Perform medical review of serious adverse event (SAE) coding
• Review seriousness, expectedness/listedness and causality of each event in the SAE
• Review due diligence queries as needed and raise additional medical queries for pertinent information regarding SAEs
• Review watchlist cases as needed
• Write medical assessments for SAEs
• Provide medical support for the Analysis of Similar Events (AOSE)
• Perform aggregate review of nonserious cases in line listings
• Evaluate SAEs for potential product quality issues
• Identify potential signals and/or Events of Special Interest from SAEs
• Participate in vendor oversight by providing training and knowledge transfer as required.
• Lead process, technology and scientific innovations for safety reviews and assessment, and reporting of adverse event data. Responsibilities include training activities, participation in selected reviews of aggregate reports contributing to the development and implementation of risk minimization action plans, etc.
• Identify and evaluate new safety signals and trends by conducting systematic reviews of aggregate data with a focus on spontaneous adverse event reports.
• Perform signal detection activities for selected products (including but not limited to real-time signal detection, interproduct data mining, and lot alerts).
• Perform validation of signals identified in reviews. Prepare summary analysis of safety data. Provide recommendations for further evaluation.
• Lead regular Safety Monitoring meetings with internal staff representing relevant line functions (R&D, Pre-clinical Toxicology, Clinical Development, Clinical Operations, Data Management, Biostatistics) to monitor the safety findings of investigational products
• Utilize highly skilled expertise and detailed working knowledge of FDA (and other regulatory agency) regulated medical safety/Pharmacovigilance, FDA regulated strategic thinking, and leadership to serve as the Sponsor's safety pharmacovigilance expert.
• Provide pharmacovigilance and benefit risk assessments of MTEM-sponsored products throughout the product lifecycle.
• Ensure that the safety surveillance and benefit risk management activities are consistent with FDA, operating processes, procedures, regulatory and legislative requirements.
• As part of the medical safety evaluation, provide written initial and follow-up review of clinical protocols, review of clinical protocol-associated safety documents (including ICFs) and agreements with partners (e.g. safety management plans, safety review committee charters, safety data exchange agreements, others), review of safety data in FDA-regulated documents such as study reports and annual reports (i.e. Data Safety Update Reports), participation in external audits from partners or regulatory authorities, and serve as subject matter expert on DSMBs or DMCs. Assist in drafting/updating and/or reviewing the safety section of the Investigator's Brochure.
• Provide medical advice/input for narratives written for Clinical Study Reports (CSRs)

Qualifications:

• Medical Degree (i.e. MD, DO, MBBS, MB ChB, MB BCh)
• Knowledge of principles of epidemiology and statistics.
• Critical thinking and analytical skills and ability to make high level decisions
• Excellent English oral and written communication skills including ability to present to internal/external groups
• Excellent level of computer literacy with Microsoft applications
• Minimum of 5 years experience in pharmacovigilance
• At least 2-3 years clinical experience with patients following post-graduate training with significant knowledge of general medicine
• Excellent interpersonal, verbal and written communication skills
• Computer proficiency, an ability to work with web-based applications and familiarity with the Windows operating system
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• Ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential
• Willingness to work in a matrix environment and to value the importance of teamwork
• Strong knowledge of international drug regulation including GCP

Location: NYC/Northern NJ; Austin, Texas; remote

Reporting Structure: This position reports to the Chief Medical Officer.

Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.

Molecular Templates Inc https://mtem.isolvedhire.com