SVP, Pharmacovigilance and Chief Safety Officer
Employment Type: Full Time
Reference Number: 1824449
Job Description Summary
Reporting to the CMO, SVP, Pharmacovigilance and Chief Safety Officer (PV) will be responsible for leading the pharmacovigilance and drug safety function within the organization including supervising key pharmacovigilance team members. You will be responsible for the strategic implementation, execution, and management of pharmacovigilance and risk management activities in conjunction with the Company's development and planned commercial activities, industry standards, and compliance with global regulations. You will work with key stakeholders within the organization to develop PV strategy for current products under development including proactively identifying and communicating emerging potential and/or urgent safety issues and to support signal detection and risk/benefit evaluation. You will have oversight of Serious Adverse Event (SAE) processing and ensure timely, compliant, and accurate safety reporting in accordance with applicable regulatory requirements, Good Clinical Practice (GCP), and standard operating procedures (SOP). The role requires both a "hands on" and a strategic mind-set to be a key leader in a scaling Company.
- Oversees and directs all aspects of global pharmacovigilance and risk management activities for investigational compounds and upcoming marketed products; actively participates in oversight of patient safety in all clinical trials and in the post-market setting.
- Provides strategic planning, implementation, and management of drug safety activities to support clinical development of company products.
- Lead role to respond and resolve safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans.
- Designs, directs, and conducts ongoing safety surveillance of company drug products using internal and external resources to ensure delivery of high-quality pharmacovigilance services.
- Provides oversight of all clinical safety activities including review of MedDRA coding of AEs, con-meds, and processing of SAEs through the entire lifecycle including preparation of analyses of similar events (ASE) for unexpected and related serious adverse events (SUSARs) from clinical trials.
- Directs the development, preparation, and compliance of periodic and annual safety reports (e.g., DSUR, PSUR, periodic line listings, BLA safety updates), investigator communications, product labeling/package inserts and other reports, as necessary.
- Provides expert safety review input into all critical documents for clinical development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs).
- Manages internal employees and external contractors to ensure delivery of quality drug safety and pharmacovigilance services, including selecting, developing, training, and evaluating team to ensure the efficient operation of the drug safety function.
- Monitors industry best practices and changes in global safety regulations and guidelines. Recommends changes and upgrades to existing departmental policies, SOPs, and systems to ensure global regulatory compliance.
- Collaborates with teams across the organization, including clinical development, clinical operations, quality, and regulatory, to provide input on all safety and PV issues including review of clinical study protocols, development plans, INDs, and serious adverse events.
- Ensures risk reduction strategies are included in relevant documents such as clinical study protocols.
- Ensures the oversight of uniform and timely processing of adverse event reports.
- Provides technical approval for investigator brochures, protocols, informed consents, final study reports.
- Maintains an environment of continuous improvement
What is Required
- MD preferred; PharmD or NP may be considered depending on breadth and depth of pharmacovigilance experience
- 15+ years of direct experience in clinical safety, pharmacovigilance, and risk management within the pharmaceutical industry characterized by positions of increasing responsibility with experience in managerial oversight, , oncology therapeutic area strongly preferred
- Expert knowledge of FDA safety regulations, ICH guidelines, EU GVP, and applicable regulatory guidance.
- Expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities.
- Demonstrated experience in a PV leadership role in both the clinical development and post-market settings with strong operational and strategic components.
- Demonstrated ability to prioritize multiple tasks and deliver to deadline with high standard of quality.
- Demonstrated success in developing and managing strategic relationships with medical oncology experts and key thought leaders;
- Experience in safety reviews of AEs/SAEs, IBs, protocols, clinical study reports, informed consents, and other safety-related documents
- Strong knowledge of GCP, ICH, and Global regulations
- Excellent communication, writing, and analytic skills
- Ability to work independently and with a team; collaborating and often contributing to discussions amongst internal teams; work effectively without a lot of support or structure.
- Ability to apply expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Thorough understanding of clinical methodologies and providing sound analytical support; quickly establish credibility as a reliable resource.
- Office environment / Domestic and International travel up to 20% may be necessary
- Proven ability to act as a medical spokesperson for external audiences;
- Knowledge and application of business planning & leadership principles, such as data analysis, goal setting, action plans, monitoring tools, directive and supportive techniques to develop and implement action plans;
About Mirati Therapeutics
Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRASG12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRASG12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer.
At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability and collaboration ground our work. These shared values are central to who we are, what we do and how we do it.
Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it's the chance to be part of something bigger.
We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.
Mirati cultivates an environment where:
- An entrepreneurial attitude is encouraged
- Our people are empowered to speak up, embrace the gray and achieve solutions
- Diverse experiences are an important of part making the best decisions
- We laugh and have fun as a work family
No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision to unlock the science behind the promise of a life beyond cancer. Together, we own Mirati's success.
Learn more at Mirati.com/careers.
Mirati is an Equal Opportunity Employer (EOE) we celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.
Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.