Merck Early Clinical Scientist in South San Francisco, California

Merck Research Laboratories South San Francisco, a wholly owned subsidiary of Merck and Co., is focused on driving discovery research. Our new multi-disciplinary discovery research site offers state-of- the-art resources to explore the most promising science combined with Merck’s world-class R&D expertise in small molecules and biologics. Located within the heart of the Bay area’s biomedical community, research conducted in our new laboratories spans exploratory biology through early clinical development and is an integral part of Merck’s powerful world-class network of drug and vaccine discovery.

At Merck, we are inspired by the belief that a research-driven enterprise dedicated to scientific excellence can create medicines and vaccines that save and improve lives. Every employee is building on our proud legacy of scientific breakthrough. Our ability to impact the lives of patients worldwide depends on the integrity, creativity, humility and scientific acumen of our team. We are creating a diverse organization that is inspired by invention and founded on a culture of respect and collaboration. At Merck Research Labs South San Francisco, you’ll have the opportunity to expand your knowledge and skills through collaboration with talented and dedicated colleagues while advancing your career.

The Early Clinical Scientist/ECS coordinates the design, planning and execution of early phase clinical trials with the Clinical Director and internal/external team members. Oversees trials within and/or across program(s)/therapeutic areas and ensures excellence in execution/compliance to support study objectives and data validity. Manages CRO performance to achieve project objectives and resolves project performance issues if they arise.

Ensures appropriate clinical safety assessment and risk management of compounds. Conducts real-time oversight of ongoing trials to identify and mitigate patient, study design, data or study conduct issues. Reviews and interprets clinical trial data. May conduct on-site study monitoring, including site training & supervision of complex, novel endpoint/biomarker collection processes. Applies knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.

Contributes to teams developing and/or improving internal job aids/SOPs. Identifies and communicates best practices within the organization.

Technical Writing & Communications

Co-authors clinical sections of protocols, clinical investigator brochures, clinical study reports, Worldwide Marketing Application/Common Technical Document (WMA/CTD) subsections, and regulatory agency update and safety reports, as well as clinical development plans, publications, and abstracts. Ensures documents are completed in accordance with applicable standards. Develops study operational documents with input from team members (e.g. site monitoring plan, study operations manual, informed consent, etc.).

Project Management

Manages trial and program projects including team activities (i.e. meetings, document/collaborative workspace management, etc.), provides risk assessment and contingency planning, under accelerated timelines. Familiar with early drug development processes, building knowledge and skills to effectively manage additional processes/procedures.

Overnight travel <5%   

Education:

  • Bachelor of Science degree (or BSN) and ≥4 years related* experience OR

  • Master’s degree and ≥3 years related* experience

  • *e.g., familiarity with or knowledge of clinical trial management and trial execution; clinical site training/monitoring; medical and regulatory writing; OR equivalent experience with developing preclinical model experiments for drug candidates (protocol authoring, experiment execution/oversight, authoring experiment reports).

Required:

  • Understanding of clinical research development process from program planning to regulatory submission

  • Able to quickly develop a working scientific knowledge of different therapeutic areas

  • Ability to manage complex operations and projects under accelerated timelines

  • Scientific, medical and/or safety writing and reporting (at least one is required)

  • Ability to partner effectively with internal and external (CRO) teams to achieve results

  • Strong team collaboration, leadership, communication (written and verbal), issue identification and resolution skills

  • Knowledge of GCP, ICH guidelines and regulatory requirements

Preferred:

  • Global Phase I subject and patient trials & safety reporting experience a plus

  • Translational and/or clinical trial experience in ophthalmologic diseases

  • Strong background in ophthalmologic research and translational application to human disease

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

If you need an accommodation for the application process please email us at staffingaadar@merck.com.

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Job Clinical Research - Clin Ops

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Title: Early Clinical Scientist

Primary Location: NA-US-CA-South San Francisco

Requisition ID: CLI006381