Associate Director, Clinical Scientist, Ophthalmology

MSD Malaysia; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement plan

Paid holidays

Vacation

Sick days

Job summary

MSD Malaysia seeks a Senior Clinical Scientist to drive scientific planning, strategy, and execution of Phase 1-4 clinical studies. You will collaborate with global cross functional team members including clinical directors and study managers to lead/support clinical trial scientific activities.

The role requires leading clinical monitoring, regulatory document collaboration with Medical Writing, and mentoring the team while guiding protocol design and study start-up activities.

Qualifications

• Minimum required credentials or higher education in life sciences.
• Experience in pharmaceutical clinical development and ophthalmology preferred.
• Strong knowledge of GCP, ICH, and regulatory expectations.

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.

Skills

Clinical Development

Clinical Research

Trials Monitoring

GCP/ICH

Strategic Thinking

Technical Writing

Education

Bachelor's degree

Master's degree

PhD/PharmD

Life sciences degree

Job description

Job Description

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 +8 years of pharmaceutical, clinical drug development, project management, and/or medical field experience in ophthalmology
• Preferred: master's degree +6 year of pharmaceutical, clinical drug development, project management, and/or medical field experience in ophthalmology
• Preferred: PhD/PharmD Degree +4 year of pharmaceutical, clinical drug development, project management, and/or medical field experience
• Preferred: Degree in life sciences, preferred.

Required Skills

• Clinical Development, Clinical Research, Clinical Sciences, Clinical Trial Documentation, Clinical Trials Monitoring, Good Clinical Practice (GCP), Life Science, Pharmaceutical Sciences, Strategic Thinking, Study Design

Equal Employment Opportunity

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts

Salary Range

The salary range for this role is $142,400.00 - $224,100.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

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

Employment Details

• Employee Status: Regular
• Relocation: No relocation
• VISA Sponsorship: No
• Travel Requirements: 10%
• Flexible Work Arrangements: Not Applicable
• Shift: 1st - Day
• Valid Driving License: No
• Hazardous Material(s): No

Location Restrictions

• 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

Company Overview

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.