Top 63 Pharmaceutical cmc Jobs in Remote

Senior Director, Clinical Operations
Syncromune —Remote
- $250,000 - $275,000 a year
- Full-time
- Background check
- 11+ years
- Office
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Sr. Associate, Contractor Quality Regulatory Lead - USD (contract)
Pfizer —Remote
- $39 - $49 an hour
- Contract
- Remote
- 5 years
- Contracts
- Senior level
- Commuter assistance
- Disability insurance
Clinical Supplies Manager
Summit Therapeutics —Remote
- $120,000 - $145,000 a year
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- 5 years
- Bachelor's degree
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Senior Regulatory Affairs Consultant
ProductLife Group —Remote
- $170,000 - $210,000 a year
- Bachelor of Science
- Bachelor's degree
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Regulatory Affairs Consultant - CMC Mid-level
SciLucent, Inc. —Remote
- $115,000 - $215,000 a year
- Full-time
- Remote
- Microsoft Word
- Writing skills
- English
- Health savings account
- Disability insurance
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3d
DIRECTOR, REGULATORY AFFAIRS
Suvanta Pharma Inc. —Remote
- $180,000 - $250,000 a year
- Full-time
- Remote
- Background check
- 7 years
- English
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ManagerSr. Manager - Regulatory Affairs
Gan & Lee Pharmaceuticals —Remote
- Full-time
- Microsoft Excel
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Senior Clinical Research Associate - Cardiovascular (EDG-2026033)
Edgewise Therapeutics —Remote
- $90 - $140 an hour
- Full-time
- Up to 50% travel
- Bachelor of Science
- 3 years
- Employee stock purchase plan
- Health insurance
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Associate Director, Regulatory Affairs, CMC
BeiGene —Remote
- $142,000 - $192,000 a year
- Full-time
- Microsoft Outlook
- Computer literacy
- Bachelor of Science
- Health savings account
- Employee stock purchase plan
Senior Director, Strategic Portfolio Management
Viatris —Remote
- $151,000 - $314,000 a year
- Full-time
- Remote
- 11+ years
- Bachelor's degree
- Doctor of Philosophy
Regulatory CMC Expert in Biologics
Lachman Consultant Services —Remote
- Online Application
- Medicine
- Doctor of Philosophy
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Director, Sales
Syner-G —Remote
- Remote
- 7 years
- Writing skills
- Office
- Paid holidays
- Paid time off
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Director, Medical Writing
SAB —Remote
- $190,000 - $230,000 a year
- Full-time
- Management
- Office
- Continuous improvement
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14d
Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge Management
BeiGene —Remote
- $172,000 - $232,000 a year
- Full-time
- 6 years
- Microsoft Outlook
- Computer literacy
- Health savings account
- Employee stock purchase plan
Regulatory Business Analyst - Regulatory Technology (Contract)
Vertex Pharmaceuticals —Remote
- $75 - $82 an hour
- Full-time
- 5 years
- Bachelor of Science
- Bachelor's degree
1d
Vice President Regulatory Affairs (Drug)
Syncromune —Remote
- $345,000 - $375,000 a year
- Full-time
- Up to 50% travel
- 11+ years
- Office
Quick Apply
Senior Drug Product Process Engineer
Nektar Therapeutics —Remote
- $175,000 - $190,000 a year
- 5 years
- Writing skills
- Mentoring
- Employee stock purchase plan
- Paid holidays
Sr. Director, Regulatory Affairs
Akebia Therapeutics —Remote
- $246,330 - $304,290 a year
- Office
- Bachelor's degree
- Doctor of Philosophy
- Health insurance
- Dental insurance
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Director/Senior Director, Global Regulatory Affairs
Secura Bio —Remote
- $212,000 - $290,000 a year
- Full-time
- Remote
- 5 years
- Office
- Senior level
Senior Manager, Clinical Trial Supplies
Crinetics Pharmaceuticals —Remote
- $140,000 - $175,000 a year
- Full-time
- Nursing
- 6 years
- Office
- Employee stock purchase plan
- Paid holidays

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Senior Director, Clinical Operations

Syncromune
Remote

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Job Details

Full-time
$250,000 - $275,000 a year

Qualifications

Staff supervision
Team leadership
Team development
ICH guidelines
Pharmaceutical company experience
Managing clinical research teams
Oncology research
Vendor relationship management
Vendor communication
Leading team collaboration initiatives
Clinical quality assurance standards
Oncology
Senior leadership
Team building

Full Job Description

The Senior Director, Clinical Operations provides strategic and operational leadership for the planning, execution, and oversight of oncology clinical trials across the company’s development portfolio. This role is accountable for end-to-end clinical operations delivery, ensuring studies are conducted efficiently, compliantly, and in alignment with corporate timelines and objectives. This individual partners closely with Clinical/Medical Development, Regulatory Affairs, Pharmacovigilance, and external vendors to drive high-quality execution of complex oncology trials, including early- and late-phase programs. The Senior Director plays a critical role in building scalable clinical operations infrastructure, mentoring teams, and representing Clinical Operations to executive leadership.

Principal Duties and Responsibilities:

Provide strategic leadership for the clinical operations function across multiple oncology programs and phases
Develop and execute clinical operations strategy aligned with overall development and corporate goals
Oversee the operational delivery of the clinical trial portfolio, ensuring adherence to timelines, budgets, and quality standards
Identify and proactively manage cross-program risks, dependencies, and resource constraints
Provide regular portfolio-level updates to Head of Clinical Operations
Ensure successful end-to-end execution of oncology clinical trials, including study planning and feasibility, start-up and site activation, enrollment and retention, trial conduct and close-out
Provide senior oversight and guidance to Clinical Trial Managers and Directors
Ensure operational feasibility is incorporated into protocol design and development plans
Support execution of complex oncology trial designs, including dose escalation and expansion cohorts, biomarker-driven studies, global, multicenter trials
Serve as a key member of the Clinical Operations leadership team
Partner closely with Clinical Development / Medical, Regulatory Affairs Biometrics (Data Management & Biostatistics), Pharmacovigilance/Safety, Biomarkers/Immunology, CMC, Device, and Supply Chain
Ensure alignment across functions on study strategy, timelines, and deliverables
Contribute to clinical development plans and regulatory strategies
Assist in forecasting and tracking clinical operations expenditures
Ensure efficient use of resources across programs
Partner with Finance and leadership to support long-range planning
Ensure all clinical trials are conducted in compliance with: ICH-GCP, FDA, EMA, and global regulatory requirements, Company SOPs and quality standards
Oversee inspection readiness activities and participate in regulatory inspections and audits
Drive a culture of quality, risk management, and continuous improvement
Ensure appropriate oversight of safety reporting, including oncology-specific considerations such as immune-related adverse events
Build, lead, and mentor a high-performing Clinical Operations team
Define roles, responsibilities, and career development paths
Support hiring and onboarding of clinical operations staff
Foster a collaborative, accountable, and solutions-oriented culture
Serve as a coach and escalation point for complex operational challenges
Establish and refine clinical operations processes, SOPs, and governance structures
Implement scalable systems and tools to support portfolio growth

Requirements:

Experience:

12+ years of clinical operations experience, including significant leadership responsibility
Demonstrated experience overseeing oncology clinical trials across multiple phases
Prior experience at a trial sponsor (early-stage biotech/pharmaceutical company preferred)
Proven success managing CROs and external vendors
Experience supporting global clinical trials

Education:

Bachelor’s degree in life sciences or equivalent by a combination of education and experience. Additional clinical trial certifications (e.g., ACRP, SOCRA) are a plus.

Knowledge/Skill:

Strong scientific acumen and ability to grasp complex scientific and technical concepts.
Strong knowledge of 21CFR, ISO, ICH, GCP, and relevant regulations, standards, directives, and guidance is essential.
Strategic thinker with strong execution focus
Exceptional communication, organizational, and problem-solving skills.
Ability to work independently and collaboratively in a fast-paced, deadline-driven matrix environment.
Ability to manage complexity, ambiguity, and competing priorities
Track record of building and scaling clinical operations teams

Supervisory Responsibilities:

This role currently supervises a team of Clinical Trial Managers and is expected to recruit, train, and manage a scalable clinical operations team.

Working Conditions:

Specify work environment:

The work environment shall be split between a virtual office environment and the Company headquarters in Des Moines, IA and Fort Lauderdale, FL.
Domestic and International travel up to 30%
Must have current passport or willingness to obtain immediately
Must be able to successfully pass a background check, drug testing, and other applicable vendor credentialing requirements
Ability to lift up to 35 pounds
Regularly required to stand, sit, talk, hear, and use hands
Prolonged periods of sitting and standing

Syncromune is an Equal Opportunity Employer.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to, the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range: $250,000-$275,000

This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company’s benefit plans.

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