Senior Medical Director, Clinical Development And Medical Safety

Remote - East Coast, USA

Mission

The Senior Medical Director, Clinical Development and Medical Safety position requires indepth subject matter expertise, strong operational strategic thinking, and leadership skills to effectively manage safety and global pharmacovigilance resulting in regulatory controlled deliverables to both internal and external partners. This includes knowledge of global regulatory requirements for adverse event reporting, relevant experience in medical review, signal detection, risk management, and benefit-risk assessment in the context of aggregate reports (DSUR). You will be responsible for providing innovative scientific knowledge, skill and technical expertise for assigned clinical programs and projects.

Reporting Relationship

This position will report to the Global VP, Clinical Development, or designee.

Duties and Responsibilities

• Oversight of the global Pharmacovigilance (PV) system to enable compliance with applicable regulatory PV requirements and guidance.
• Accountable for overseeing medical monitoring to clinical studies.
• Leads and/or participates in clinical/medical advisory panels and investigator meetings.
• Input into the clinical strategy, including the Clinical Development plan and coordination of cross-functional execution of clinical strategy by the clinical sub-teams.
• Provide input and guidance on scientific and clinical issues
• Contributes as author and provides clinical review of protocols, clinical study reports, publications, core safety information, labels, and regulatory reports with focus on providing overview for the medical analysis and safety sections
• Remains up to date with current information on regulations, guidelines, and practices, and therapeutic area knowledge and ensures consistent best practice across all activities.
• Represents the company in the academic Medical/Scientific Community to facilitate the constructive exchange of positions and ideas.
• Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions.
• Accountable for the adherence to Good Clinical Practice, data integrity principles, and other key Company policy requirements by external and contract partners
• Review and summarize scientific literature relevant to pharmacovigilance on assigned projects
• Responsible for the operational management and oversight of case processing activities performed internally and externally by vendors (CROs), as well as expedited safety reporting
• Support quality management function to ensure compliance with local and international safety requirements and regulatory inspection readiness in collaboration with QA
• Provide expertise on DSPV operational processes to the Clinical Research and Medical Affairs teams, the Clinical Development Operations team, the Regulatory Affairs team plus other stakeholders as required
• Stay current with international pharmacovigilance requirements and guidelines
• Serve as point of contact for cross-functional development teams and is involved in all safety surveillance activities, including safety review of individual safety cases, signal detection/evaluation, and risk management activities
• Represent DSPV at leadership team meetings
• Authoring risk management plans, DSURs, CSR, ICSFs, IBs; Regulatory Authority inspection experience, IND, NDA, BLA/NDA
• Coordinate cross-functionally, on inspection readiness and ensure team inspection readiness
• Review adverse event reports including but not limited to all Serious Adverse Events, Events of interest, and expedited individual case safety reports ensuring that appropriate interpretation, consistency, and quality are applied to adverse event case assessment. Generate Analysis of Similar Events
• Lead and coordinate all DSMB and/ or Safety Advisory Committee meetings
• Exchange of safety data with partners, as required
• Ensure timely submission of expedited safety reports and other external submissions through effective vendor management and performance metrics review. Partner with Clinical Quality, to identify CAPAs required to address late reporting and maintain current PV regulatory intelligence in the company safety database
• Other duties as assigned.
This job description is subject to change at any time.

Educational Qualifications

• Medical degree (e.g., MD/MBBS) with Ophthalmology experience
Ophthalmologist/Retina Specialist is strongly preferred

Additional Qualifications

• Ten (10+) plus years of relevant scientific, clinical, and/or drug development experience, and five plus (5+) years of pharmacovigilance and/or medical monitoring experience in drug development pharma/biotech industry.
• Experience with FDA and other regulatory agencies preferred
• Experience with Multimodal imaging for safety review is strongly preferred Experience specific to Ophthalmology/Gene therapy preferred
• Experience with risk mitigation strategies preferred.
• Demonstrated ability to create, evaluate, and maintain effective business processes and implement procedures, systems, and tools to maximize resources within a Drug Safety department
• Thorough knowledge and experience in all aspects of safety reporting for clinical trials Strong knowledge and experience with currently available drug safety database systems, electronic document management systems, and QC tools. This also includes MedDRA and linked technologies
• Operational expertise with ARGUS preferred
• Thorough knowledge of the 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
• Works collaboratively (establishes shared purpose across boundaries)
• Develops people and the organization (invests in long-term development of others)
• Strong analytical and problem-solving skills with superb attention to detail.
• Strong verbal, written technical communication and presentation skills
Proficiency with Microsoft, Outlook, Word, Excel, PowerPoint and Zoom

Physical Requirements

• Physical demands: (check one)
  • sedentary (< 10 lbs.) light work (< 20 lbs.) medium work (< 50 lbs.) heavy work (< 100 lbs.) very heavy work (>100lbs.)
Physical activity: (check all that apply) repetitive motion balancing stooping lifting climbing kneeling/crouching crawling reaching standing typing/grasping walking pushing/pulling
• • hearing
• Visual acuity; preparing/analyzing data, transcribing, reading, and writing
Working conditions; indoor office environment

Supervisor Responsibilities

This position requires supervisory experience.

Measures of Performance

• An initial Performance Review (PR) will be completed three months from hire date.
• After initial PR, quarterly check-ins will be conducted with employee and direct supervisor to include a mid-year and year-end review.
• One-on-one meetings with the direct supervisor will be conducted weekly to provide updates on daily duties and responsibilities as well as review progress towards goals and objectives.