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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical development and medical advisory roles, with a strong foundation in clinical trial design, regulatory guidelines, and patient safety. Proven ability to provide scientific input and support business development initiatives in the pharmaceutical industry.
Highest-signal resume keywords
Medical DegreeActive Medical LicenseClinical Development ExperienceClinical Trial DesignRegulatory Guidelines Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical MedicineResearch MethodologiesBiostatisticsAdverse Event ReviewMedical Case ReviewProtocol ReviewClinical Study Reports ReviewInvestigative Drug Brochures ReviewPatient NarrativesClinical Safety/Efficacy Summaries
Soft Skills
Excellent Communication SkillsInterpersonal SkillsInitiativeFlexibilityAbility to Establish Relationships
Industry Keywords
ImmunologyPain ManagementNeurologyRespiratoryClinical TrialsPharmaceutical IndustryEthical RegulationsFederal Drug Development RegulationsBusiness DevelopmentRequests for Proposals
About the role
Key responsibilities & impact- Provide medical, clinical, and scientific advisory expertise across multiple therapeutic areas, including Immunology, Pain Management, Neurology, and/or Respiratory
- Serve as Medical Advisor on assigned projects
- Provide medical support to investigative sites and project staff for protocol-related issues
- Review and clarify trial-related Adverse Events (AEs) and coding
- Conduct medical case review of Serious Adverse Events (SAEs), including case documentation and patient narratives
- Conduct medical review of protocols, Investigative Drug Brochures (IDBs), and/or Case Report Forms (CRFs)
- Conduct medical review of Clinical Study Reports (CSRs), patient narratives, marketing applications, clinical safety/efficacy summaries and overviews, and other high-profile documents
- Serve as Scientific Advisor and guide Project Managers on medical and scientific aspects of assigned projects
- Participate in developing the Medical Monitoring portion of client proposals, including budgeting
- Support Business Development by reviewing and providing medical/scientific input on Requests for Proposals (RFPs)
- Participate as a Rho representative in bid defenses and other sponsor meetings
- Support feasibility activities as required
- Consult with senior management, customers, and project teams to ensure clinical-trial subject safety and the scientific and ethical integrity of trial design and conduct
- Provide medical input to clinical programs and clinical development and regulatory input as needed
Requirements
What you’ll need- A medical degree from a fully accredited medical school
- Holding (or having held) an active medical license in good standing
- 5+ years of experience in clinical medicine beyond residency
- 5+ years of clinical development experience, ideally in the pharmaceutical or a closely related industry
- Good understanding of research methodologies and clinical trial design, including biostatistics
- Good understanding of scientific and ethical regulations and guidelines pertaining to clinical research, including knowledge of federal drug development regulations and guidelines
- Ability to establish and meet multiple concurrent priorities, deadlines, strategic department goals and objectives
- Skills in providing consultation and advice on multiple assignments
- Initiative and flexibility
- Ability to establish and maintain cooperative and effective working relationships with coworkers, managers, and clients
- Excellent communication and interpersonal skills, ideally with experience/expertise in public speaking and engaging external stakeholders
Benefits
Comp & perks- Medical, vision, and dental insurance
- Health Savings Account (HSA)
- Flexible Spending Account (FSA)
- Employee Assistance Program (EAP)
- Life and disability insurance
- 401(k)
- Paid time off
- Holidays
- Parental leave
- Bereavement leave
- Work-life balance and flexibility