Staff Scientist, Clinical Research

This is a fully remote position, open to applicants in Colorado, +1 more state.

📋 Description

• Design and implement strategies for generating and disseminating clinical evidence across designated New Product Development and Life-Cycle Management initiatives.

• Collaborate with teams in Clinical R&D, R&D, Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics, and Market Access.

• Align evidence strategies with regional Clinical R&D leads and key countries/regions of strategic importance.

• Create and draft clinical trial protocols, informed consent documents, investigator brochures, and various other study materials.

• Prepare study budgets and work with Clinical Operations on agreements with investigators, site contracts, vendor agreements, payments, and financial disclosures.

• Execute assigned clinical programs punctually, within budget, and in adherence to regulations and standard operating procedures (SOPs).

• Collaborate with Clinical Operations and BSDM teams to enhance engagement and fulfill clinical project obligations.

• Maintain connections with core study teams and proactively identify and communicate project challenges to leadership.

• Prepare annual reports, study closure reports, and clinical sections for IDE, PMA, 510(k), and other regulatory submissions.

• Critically evaluate literature and compose Clinical Evaluation Reports for new products.

• Assist in scientific discussions related to clinical matters with regulatory agencies and notified bodies.

• Analyze and disseminate evidence via abstracts, manuscripts, clinical study reports (CSRs), and activities related to market access and reimbursement.

• Cultivate relationships with key investigators.

• Ensure the registration of clinical trials and the posting of results on ClinicalTrials.gov.

• Develop a comprehensive understanding of the product pipeline, portfolio, and business needs.

• Keep management updated on developments and issues impacting clinical strategy and portfolio management.

• Communicate business-related issues or opportunities to higher management.

• Ensure compliance with relevant federal, state, local, and Company regulations, policies, and procedures.

• Perform additional duties as required.

⛳️ Requirements

• A Bachelor’s degree or equivalent in Biological Science or a related field.

• At least 6 years of related experience in scientific, technical, or clinical research.

• Knowledge of Good Clinical Practices (GCP).

• Familiarity with the regulations and standards applicable in clinical areas/regions.

• Strong presentation skills and the ability to effectively influence others.

• Proficient in both written and oral communication.

• Demonstrated leadership in a professional and ethical manner.

• Competent technical writing skills.

• Solid understanding of clinical research science and processes.

• Knowledge of product development processes, team dynamics, healthcare market conditions, clinical trends, and global clinical trial regulations.

• Ability to provide strategic scientific and clinical research insights across NPD and LCM projects.

• Proven experience in delivering clinical projects within a clinical/surgical research environment on time, within budget, and in compliance with SOPs and regulations.

• Capable of leading study teams and achieving critical milestones.

• Ability to collaborate across Clinical R&D functional areas to meet business objectives.

• Skilled at building collaborative relationships with internal and external partners and stakeholders.

• Ability to influence, shape, and lead initiatives without direct reporting authority.

• Must adhere to all relevant laws, policies, compliance requirements, and professional standards.

🏝️ Benefits

• Consolidated retirement plan (pension).

• Savings plan (401(k)).

• Eligibility to participate in the long-term incentive program.

• Vacation entitlement of 120 hours annually.

• Sick leave of 40 hours per calendar year; 48 hours per year for employees in Colorado; 56 hours per year for employees in Washington.

• Holiday pay, including Floating Holidays totaling 13 days per calendar year.

• Up to 40 hours of Work, Personal, and Family Time annually.

• Parental Leave of 480 hours within one year following the birth, adoption, or foster care of a child.

• Bereavement Leave of 240 hours for an immediate family member; 40 hours for an extended family member each year.

• Caregiver Leave of 80 hours in a 52-week rolling period.

• Volunteer Leave of 32 hours per calendar year.

• Military Spouse Time-Off of 80 hours per calendar year.