Senior Scientist, Clinical Operations - Ophthalmology

MSDRahway, NJ
$117,000 - $184,200Onsite

About The Position

This position drives scientific planning, strategy, and execution of Phase 1-4 clinical studies. Under the direction of the Program Lead, you will collaborate with global cross ­functional team members including clinical directors and study managers to lead/support clinical trial scientific activities.

Requirements

  • Demonstrated ability to drive and manage scientific activities on clinical protocols.
  • Apply strong knowledge of clinical research regulatory requirements (e.g., GCP and ICH).
  • Manage multiple competing priorities with good planning, time management, and prioritization skills.
  • Advanced analytical skills with the ability to interpret clinical trial data and synthesize conclusions.
  • Interact with key stakeholders across department, division, and company. Role requires a proactive approach, strategic thinking and leadership driving toward study goals.
  • Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division.
  • Demonstrated ability to effectively delegate and assign activities to meet the business needs.
  • Problem solving, prioritization, conflict resolution, and critical thinking skills.
  • Build team capabilities through proactive coaching.
  • Advanced communication, technical writing, and presentation skills.
  • Clinical Data
  • Clinical Protocol
  • Clinical Research
  • Clinical Study Design
  • Clinical Trial Compliance
  • Clinical Trials
  • Clinical Trials Analysis
  • Data Analysis
  • Drug Development
  • ICH GCP Guidelines
  • Ophthalmology
  • Regulatory Compliance
  • Strategic Thinking

Nice To Haves

  • Current Employees apply HERE
  • Current Contingent Workers apply HERE
  • US and Puerto Rico Residents Only:
  • San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
  • Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
  • Search Firm Representatives Please Read Carefully
  • Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are place, introductions are position specific. Please, no phone calls or emails.

Responsibilities

  • Responsible for the clinical/scientific execution of clinical protocol(s).
  • Serves as the lead clinical scientist on the clinical trial team.
  • Collaborates with the Medical Writer on clinical/scientific and regulatory documents.
  • Partners with Study Manager on study deliverables.
  • Participates in the set up and design during study start up (e.g., database set up).
  • Lead medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaboration with the Clinical Director.
  • Builds talent and capabilities of direct/indirect team members through proactive coaching, mentoring and development opportunities.
  • May include management of direct reports including assignment of resources, professional development, and performance management.
  • May serve as a subject matter expert and/or participate on process improvement teams.

Benefits

  • medical, dental, vision healthcare and other insurance benefits (for employee and family)
  • retirement benefits, including 401(k)
  • paid holidays
  • vacation
  • compassionate and sick days
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