Senior Manager, Clinical Research

Job Description

Physician, Senior Manager, Ophthalmology

As Clinical director/scientist in ophthalmology China Product Development Team (CPDT), clinical research physician will play key scientific leadership role and will be responsible for China clinical development plan.

• This individual need work closely and proactively with global ADT and be agile to global development strategy update, and work closely with China project team including RA, STATS, PM, clinical trial operation, medical affair, new product planning, non-clinical and clinical pharmacology for the planning and execution of China registration strategy.

• Clinical and Regulatory Strategy Development： Drive China clinical development strategy and develop the best, most suitable clinical plan to accelerate China registration; Get alignment with ADT and obtain CDRC/LDRC endorsement.

• Clinical documents preparation: including protocol development and amendment, CSR preparation, clinical documents preparation in regulatory communication and submission like pre-IND, IND and NDA dossier including but not limited to briefing book, clinical overview and clinical summaries;

• Clinical Trial Execution: Feasibility assessment; Protocol training and ophthalmology-specific testing training; Medical monitoring to ensure high-quality data

• Innovation & Scientific Engagement: Scientific leadership in the assessment of ophthalmic diseases and early compounds; KOL engagement;  SIE meetings; Publications;

Required Skills:

Accountability, Accountability, Adaptability, Business Etiquette Training, Clinical Documentation, Clinical Medicine, Clinical Quality Management, Clinical Research, Clinical Study Design, Clinical Trial Documentation, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Data Analysis, ICH GCP Guidelines, Investigation Procedures, Medical Research, Medical Review, Medical Writing, New Product Introduction (NPI), Process Improvements, Product Planning, Regulatory Compliance, Risk Management, Scientific Leadership {+ 3 more}

Preferred Skills:

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Current Contingent Workers apply HERE

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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. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

no

Job Posting End Date:

01/31/2026

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