Senior Scientist, Clinical Research

Biopharma Careers; West Point (MS); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Biopharma Careers is seeking an Early Clinical Scientist to coordinate the design, planning and execution of early phase clinical trials under the Clinical Director. You will oversee cross-functional teams to ensure data validity and regulatory compliance, and you may conduct on-site monitoring and training.

The role requires solid knowledge of GCP/ICH guidelines and strong writing skills for protocols, reports, and submission documents.

Qualifications

• Degree in Life Sciences is required.
• Bachelor’s degree with 6+ years of clinical operations experience.
• Master’s degree with 4+ years in related fields is a plus.
• PhD with 2+ years in clinical development is advantageous.

Responsibilities

• Coordinate design, planning and execution of early phase clinical trials.
• Co-author clinical sections of protocols, CTDs, and regulatory reports.
• Manage trial and program projects with cross-functional teams.

Skills

GCP & ICH

Clinical trial management

Regulatory writing

Team collaboration

Safety writing

Study management

Education

Degree in Life Sciences

Bachelor’s degree + ≥6 years experience

Master’s degree + ≥4 years experience

PhD/doctorate + ≥2 years experience

Job description

Job Description

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 internal/external team 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 thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.

Represents Early Stage Development on cross-functional teams to develop and/or improve internal job aids/SOP/clinical development procedures. Identifies and communicates best practices within the organization. Promotes departmental adaptation of new procedures.

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.

Education Minimum Requirement:

• Degree in Life Sciences
• Bachelor’s degree and ≥6 years related* experience, OR
• Master’s degree and ≥4 years related* experience, OR
• PhD or doctorate with ≥2 years related* experience
• *e.g., knowledge of clinical trial management and trial execution; clinical site training/monitoring; medical and regulatory writing

Required Experience and Skills:

• At least 3 years experience in an operational clinical scientist or study manager role in clinical research at a pharmaceutical or biotech company.
• 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 teams to achieve results
• Strong team collaboration, leadership, communication (written & verbal), issue identification and resolution skills
• Knowledge of GCP, ICH guidelines and regulatory requirements

Preferred Experience and Skills:

• Global Phase I subject and patient trials, safety reporting, and regulatory WMA submission experience a plus.
• Experience managing Immunology and/or vaccine trials with an ability to think outside of the box, explore novel ways of working and comfortably navigate ambiguity to drive results also a plus.

Required Skills:

• Adaptability, Adaptability, Biopharmaceutical Industry, Clinical Development, Clinical Research, Clinical Study Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Analysis, Drug Development, Ethical Compliance, Ethical Standards, ICH GCP Guidelines, Immunology, Medical Writing, Multiple Therapeutic Areas, Phase I Studies, Project Management, Protocol Development, Regulatory Requirements, Regulatory Submissions, Regulatory Writing, Risk Assessments, Scientific Publications, Technical Writing {+ 1 more}

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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.

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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:

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The salary range for this role is $117,000.00 - $184,200.00

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.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

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.

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