Senior Manager, Clinical Research at Merck Sharp & Dohme Corp. /Netherlands

, , China -

Full Time

Start Date

Immediate

Expiry Date

26 Mar, 26

Salary

0.0

Posted On

26 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Accountability, Adaptability, Clinical Documentation, Clinical Medicine, Clinical Quality Management, Clinical Research, Clinical Study Design, Clinical Trial Documentation, Clinical Trial Planning, Clinical Trials, Data Analysis, Medical Research, Medical Review, Medical Writing, Regulatory Compliance, Scientific Leadership

Industry

Pharmaceutical Manufacturing

Description

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: 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. 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 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. 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.

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Responsibilities

The Senior Manager will lead the clinical development plan for ophthalmology in China, collaborating with various teams to ensure alignment with global strategies. Responsibilities include driving clinical development strategy, preparing clinical documents, and executing clinical trials.