[ref. f99303800] Newark - Director, Medical Device Clinical Strategy

Overview:

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.

Be part of our movement, let’s pursue excellence together.

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.

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 and evidence generation plans and future materials.
• Partner with reimbursement, market access and medical colleagues to identify immediate opportunities to create additional support material with existing data.
• Be the internal “go-to” resource for medcial device clinical research/ scientific needs questions.

This position will work closely with many internal departments, in particular, with the clinical operations staff, data management, product development, project management and CROs to assure the timely and effective design and execution. This role will also partner with multiple other cross-functional partners, including Medical Affairs, HEMA/ HEOR partners, Field Market Access, Market Access Marketing, Commercial Marketing & Sales, Professional Education, Regulatory Affairs, and Legal; and with external consultants.

Qualifications:

Qualifications:

• Proven ability to think strategically and succeed with indirect influence and independent direction
• Demonstrated detailed knowledge of medical/surgical procedures, and hospital/acute care medical practices (orthopedic and/or pain management standards and guidelines preferable)
• Demonstrated commitment to working within Regulatory and Compliance constructs
• Proven knowledge of and experience in Phase 1-4 clinical trial design and protocol development
• Demonstrated solid working knowledge of cGCP, ICH and other relevant clinical development regulations and processes to include appropriate FDA regulations including NDA, 505(b)(1), 505(b)(2), 510 (k) regulatory pathways preferred
• Demonstrated understanding of statistics and statistical methods
• Proven success in cross-functional collaboration: partner, communicate, and accomplish goals across an organization
• Excellent written and verbal English communication skills including presentation skills to groups of all sizes at executive levels
• Able to travel 50%+

Supervisory Responsibilities: This role may have supervisory responsibilities.

Education and Experience:

• Bachelor’s degree required
• Masters degree in a health, biological sciences or research related field preferred
• Minimum 8 years of experience in medical device industry with at least 5 years of hands-on managerial experience running clinical trials and managing teams required
• Experience working in some CRO matrix environment required
• Experience creating and leading clinical development programs preferred

While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms, and stoop. Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse.

The role may include work from home or remote locations. This position may or may not be a typical office setting, staff in cubicles. Noise level is moderate such as consistent printer, telephone ringing, conversation, airport paging and airplane noise.

Benefits:

Benefits:

• Medical, Prescription, Dental, Vision Coverage
• Flexible Spending Account & Health Savings Account with Company match
• Employee Assistance Program
• Mental Health Resources
• Disability Coverage
• Life insurance
• Critical Illness and Accident Insurance
• Legal and Identity Theft Protection
• Pet Insurance
• Fertility and Maternity Assistance
• 401(k) with company match
• Flexible Time Off (FTO) and 11 paid holidays
• Paid Parental Leave

Pay Transparency:

The base pay range for this role in California is $171,200 per year to $235,400 per year.

The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications.

EEO Statement:

At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.