Senior Scientist, Clin. Operations (m/f/d)

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.

Job 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.

Core Skills

Demonstrated ability to drive and manage scientific activities on clinical protocols. This position may represent the company through external partnerships, collaborations, and key strategic engagements. This includes the ability to:

• 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

Education/Experience Preferred

• Bachelor's Degree +9 years of pharmaceutical, clinical drug development, project management, and/or medical field experience in ophthalmology

• OR Master's Degree +6 year of pharmaceutical, clinical drug development, project management, and/or medical field experience in ophthalmology

• OR PhD/PharmD Degree +2 year of pharmaceutical, clinical drug development, project management, and/or medical field experience

• Degree in life sciences, preferred.

Required Skills:

Adaptability, Business Management, Clinical Data, Clinical Operations, Clinical Protocol, Clinical Research, Clinical Study Design, Clinical Trial Compliance, Clinical Trial Management, Clinical Trials, Clinical Trials Analysis, Conflict Resolution, Data Analysis, Drug Development, Ethical Standards, ICH GCP Guidelines, Medical Writing, Motivation Management, Ophthalmology, Prioritization, Project Management, Regulatory Compliance, Regulatory Documents, Scientific Publications, Strategic Thinking

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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 in place, introductions are position specific. Please, no phone calls or emails.