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Staff Scientist, Clinical Development – Research
Johnson & Johnson. Develop clinical evidence generation and evidence dissemination strategies across New Product Development and Life-Cycle Management projects .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical evidence generation, regulatory compliance, and project management within clinical research. Proficient in technical writing and collaboration across cross-functional teams to deliver clinical programs effectively.
Highest-signal resume keywords
Clinical Trial Protocol DevelopmentGood Clinical PracticesTechnical Writing SkillsRegulatory SubmissionsClinical Research Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Evidence GenerationClinical Evaluation ReportsStudy Budget PlanningClinical Data InterpretationClinical Research ScienceProduct Development ProcessesBiomaterials KnowledgeClinical Trial RegulationsStudy Report DraftingFinancial Disclosure Management
Soft Skills
LeadershipEffective CommunicationInfluencing SkillsCollaborationRelationship Building
Industry Keywords
New Product DevelopmentLife-Cycle ManagementClinical OperationsHealth EconomicsMarket AccessRegulatory AffairsBiostatisticsClinicalTrials.govSOP ComplianceStakeholder Engagement
About the role
Key responsibilities & impact- Develop clinical evidence generation and evidence dissemination strategies across New Product Development and Life-Cycle Management projects
- Collaborate with Clinical R&D and cross-functional partners including R&D, Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics, and Market Access
- Develop and draft clinical trial protocols, informed consents, investigator brochures, and other study materials
- Plan study budgets and collaborate with Clinical Operations on investigator agreements, site contracts, vendor agreements, payments, and financial disclosures
- Deliver assigned clinical programs on time, within budget, and in compliance with regulations and SOPs
- Partner with Clinical Operations, Biostatistics, and Data Management teams
- Build relationships with study core teams, investigators, and other stakeholders
- Draft study reports, annual reports, study close-out reports, and clinical sections for IDE, PMA, 510(k), and other regulatory submissions
- Critically assess literature and draft Clinical Evaluation Reports
- Support clinical scientific discussions with regulatory agencies and notified bodies
- Interpret and disseminate evidence through abstracts, manuscripts, CSRs, and clinical data for market access and reimbursement
- Ensure study registration and results posting on ClinicalTrials.gov
- Develop understanding of the pipeline, product portfolio, and business needs
- Keep management informed of developments and issues affecting clinical strategy and portfolio management
- Communicate business issues or opportunities to the next management level
- Ensure personal and Company compliance with applicable regulations, policies, and procedures
Requirements
What you’ll need- A Bachelor’s or equivalent degree in Biological Science or related discipline
- Minimum of 6 years of related scientific, technical, or clinical research experience
- Background or experience in Biomaterials and/or Spine preferred
- Understanding of Good Clinical Practices
- Understanding and application of regulations and standards applied in clinical areas/regions
- Good presentation skills and ability to effectively influence others
- Written and oral communication skills
- Leadership in a professional and ethical manner
- Technical writing skills
- Understanding of clinical research science and processes, product development processes, team dynamics, healthcare market environment, clinical trends, and global clinical trial regulations
- Ability to provide scientifically strategic and scientific clinical research input across NPD and LCM projects
- Proven track record delivering clinical projects in a clinical/surgical research setting on time, within budget, and in compliance with SOPs and regulations
- Ability to lead study teams to deliver critical milestones
- Ability to collaborate across Clinical R&D functional areas and meet business objectives
- Ability to build collaborative relationships with internal and external partners and stakeholders
- Ability to influence, shape, and lead without direct reporting authority
- Must follow applicable laws, policies, regulations, procedures, and compliance requirements
Benefits
Comp & perks- Vacation – 120 hours per calendar year
- Sick time – 40 hours per calendar year; 48 hours per calendar year for employees residing in Colorado; 56 hours per calendar year for employees residing in Washington
- Holiday pay, including Floating Holidays – 13 days per calendar year
- Work, Personal and Family Time – up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
- Remote work options may be considered case-by-case if approved by the Company