Description
Kelly® Science & Clinical is seeking a Senior Medical Director for a fulltime, Direct Hire role with a pharmaceutical client based in the San Fran Bay area. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Position Overview:
The Senior Medical Director, PV will serve as a thought leader, with a high level of experience as a medical safety professional with a strong ability and broad knowledge of global drug safety, medical monitoring, and post marketing safety surveillance. This role will lead the drug safety and pharmacovigilance operations to ensure the consistency and accuracy of adverse event reporting in clinical studies including, but not be limited to, initial safety review of adverse events, medical review of clinical data, interaction with clinical research sites, drug safety vendors, review of source documents, preparation of documents for submission to regulatory authorities, medical monitoring support to clinical trial sites for questions related to clinical trial, and for emergency unblinding. This individual will apply deep medical and clinical expertise to ensure high-quality decision-making and will work collaboratively across the enterprise to align drug development programs with leadership goals and ensure efficient, end-to-end execution of clinical development plans. This role is pivotal in shaping leading-edge clinical science applied to CNS drug development. In this role, the individual will build and lead the PV group.
This is a full-time position and may be performed remotely from any location within the continental U.S. The position will report to the SVP, Clinical Research and Development.
Key Duties & Responsibilities:
Key responsibilities of this role include, but are not limited to:
• Provide leadership to the pharmacovigilance function and multi-disciplinary study teams.
• Manage and lead the PV group, manage resources, and budget pertinent to the PV activities.
• Serve as a medical monitor/advisor of ongoing clinical trials.
• Ensure compliance with all applicable laws and regulations and as appropriate, local, and foreign regulatory requirements, for the processing and reporting of adverse events in coordination with regulatory affairs.
• Responsible for the overall clinical risk management and safety surveillance of all future investigational products.
• Provide medical review and advice of post marketing safety data.
• Prepare/oversee medical monitoring plans and present the study protocol's safety in the IM meetings and site initiation activities.
• Act as 24/7 available medical contact person for questions related to clinical trial and for emergency unblinding.
• Medical review of coding, ensure accuracy of MedDRA coding of adverse events' terms, medical history, and WHO Drug coding of concomitant medications.
• Medical review of eCRF related to clinical and safety data.
• Medical review of individual case safety report (ICSR): adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs), adverse drug reactions (ADR), causality assessment, signal detection, case narrative, aggregate reports, medical review of listings of safety data.
• Write/review the relevant safety sections of the NDA and different types of regulatory meeting packages.
• Provide medical input and review of annual reports, PADER, PSUR, DSUR, other benefit risk assessment reports, updates of package insert/label, summary of product characteristics, and investigator's brochure.
• Prepare and review the answers to questions from Health Authorities, medical input in Risk Management Plan (RMP).
• Participate in DSMB preparation and activities.
• Collaborate with clinical operations and clinical research to optimize study designs for operational efficiency, ensuring timely and cost-effective delivery.
• Oversee the design and execution of clinical research studies and review key clinical documents (e.g., protocols, clinical study reports, regulatory submissions).
• Maintain current knowledge of all applicable drug safety guidelines and regulations (FDA, ICH, IRB, EMA).
• Establish the necessary PV SOPs and work guidance.
Qualifications:
• MD or DO, with relevant post-graduate clinical training.
• Minimum of 8 years of relevant work experience.
• Experience in NDA and IND submissions.
• Knowledge of medical and therapeutic terminology.
• Deep understanding of the drug development process (preferred in CNS therapeutic areas).
• Strong knowledge of regulatory requirements (GCP, ICH guidelines) and worldwide safety regulations.
• Experience in managing PV budgets and financial risk in clinical research.
• Ability to review emerging data and proactively ensure the delivery of high-quality study results.
• Skilled communicator and leader, able to articulate ideas clearly and integrate team feedback.
• Excellent writing skills, and ability to convey moderately complex technical information clearly to others.
• Ability to work independently in a dynamic and fast-moving environment.
• Proficient in meeting project timelines/deliverables and attention to detail, process, deadlines, and high-quality results.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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