Clinical Strategy Director

4 days ago

Parsippany, New Jersey, United States Pacira Pharmaceuticals Full time
About Pacira

Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for healthcare 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.

Job 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.

Key Responsibilities
  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Monitor and identify clinical and evidence gaps for Pacira medical devices to support scientific and provider adoption needs, while supporting reimbursement.
  6. Own and manage relationships with key clinical investigators for medical device trials, providing guidance and support.
  7. Partner with clinical and clinical operation partners to monitor, evaluate, and adjust when necessary the execution and coordination of medical device trials and protocol.
  8. Interface with potential clinical research partners in assessing and evaluating new and proposed research opportunities.
  9. Ensure the organization executes medical device clinical studies to establish the safety, efficacy, and commercial viability of new products/indications as necessary.
  10. Actively participate as the lead research team member, interacting with and providing oversight to help assure appropriate study protocols and outcomes to meet needs, investigator compliance, regulatory guidelines, and company standard operating procedures.
Requirements

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 5%+.

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.

Physical Demands

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.

Work Environment

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

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.

The base pay range for this role in California is $160,000 per year to $220,000 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

Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law.

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.

Agency Disclaimer

Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post.

Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes.

Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency.

Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.

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