Jobs and Careers

Director, Medical Device Clinical Strategy

San Diego, United Statesfull_timeVerifiedPosted 4 Oct 2024

💰 $220,000/yr($160,000/yr – $220,000/yr)

About the role

About Pacira Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results. Why work with us? Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people. At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let’s pursue excellence together. Summary:This role is responsible for creating the overarching strategy for Pacira Clinical and Evidence Generation for medical devices and is both internal and external facing. This role will also be responsible for working cross functionally to ensure the execution of clinical development plans, implementation of the overall clinical strategy and management. Essential Duties and Responsibilities

Coordinate the execution of tactics that will result in clinical studies and real world evidence creation that will ultimately build the clinical story of Pacira medical devices for the market, providers, value analysis committees and payers.
Act as the internal expert, advising and helping build support material for internal and field groups on matters related to the scientific and clinical support/evidence for medical devices.
Create a strategy for Pacira Medical Device short term and long term clinical / research/ evidence needs by working with internal and external partners to implement and execute in a timely and cost-effective manner.
Work closely with marketing, medical, clinical and clinical operations teams to ensure all clinical/ research activities for medical devices are aligned to broader strategies and clinical goals.
Monitor and identify clinical and evidence gaps for Pacira medical devices to support scientific and provider adoptions needs, while supporting reimbursement.
Own and manage relationships with key clinical investigators for medical device trails providing guidance and support.
Partner with clinical and clinical operation partners to monitor, evaluate and adjust when necessary the execution and coordination of medical device trials and protocol.
Interface with potential clinical research partners in assessing and evaluating new and proposed research opportunities.
Ensure the organization executes medical device clinical studies to establish the safety, efficacy and commercial viability of new products/ indications as necessary.
Actively participate as the lead research team member interacting with and providing oversight to help assure appropriate study protocols and outcomes to need needs, investigator compliance, regulatory guidelines and company standard operating procedures.
Indirectly oversee and influence the management of study timelines, deadlines and budgets.
Ensure that organization can clearly deliver the medical device clinical and scientific message to the provider community; clearly understand the current gaps and needs from the market and execute on plans to fill those gaps.
Work with clinical research/operations team and Regulatory Affairs in the preparation of project-related documents and regulatory submissions, including Investigator’s Brochures, Annual Reports, INDs and NDAs.
Participate in investigator meetings, capturing VOC and translating company needs/strategy.
When necessary, participate in key site initiation, site oversight and monitoring, on-site presentations, site close-out, understanding adverse events. Will interact with a multidisciplinary team.
Communicate and interact frequently and effectively with in-house personnel, clinical sites and outside contractors/CROs.
Develop and maintain professional relationships with key physicians, clinicians and principal investigators to assure good clinical input to Pacira Medical Device product development process, marketing, market access and sales teams.
Work with Director of Reimbursement Strategy to translate insights from VOC/ payers/ societies into actional plans that shape our clinical