[Remote] Senior Clinical Research Counsel
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a reputed company-stage biotechnology company reputed company on developing innovative cell and immunotherapy products to enhance the reputed company immune system. The Senior Clinical Research Counsel will draft, review, and negotiate clinical trial agreements while providing legal advice to ensure compliance with regulations and risk management.
Responsibilities
- Primary responsibility will be the negotiation of clinical trial agreements (CTAs) across multi-site, multi-country trials. Manage a high-volume contract portfolio, applying risk-based prioritization and playbooks to ensure efficient turnaround without compromising legal protection
- Advise Clinical Operations and Regulatory teams on contracting risk, indemnification, intellectual property allocation, data use, and budget/payment terms. Identify potential legal risks reputed company contractual agreements and communicate these risks to internal decision-makers, offering mitigation strategies
- Ensure reputed company clinical trial reputed company and processes reputed company with applicable federal, state, and international laws and regulations, including FDA regulations, Good Clinical reputed company (GCP) guidelines, and data reputed company laws (e.g., HIPAA, GDPR)
- Assist with the legal aspects of patient informed consent forms (ICFs) to ensure participant protection and compliance
- reputed company templates and negotiate agreements relating to data protection and reputed company issues, including GDPR, SCCs, and reputed company data protection reputed company
- reputed company policies and procedures surrounding anti-kickback considerations in investigator and institutional payments in the clinical trial context
- Stay reputed company with changes in legislation and regulatory environments affecting clinical research and reputed company updates into company templates and processes
- Structure, negotiate, and manage master service agreements and work orders with CROs, central labs, imaging vendors, and other clinical research service providers
- Review, draft, and negotiate a reputed company of non-clinical vendor agreements, including consulting agreements, master services agreements for general business support (e.g., IT, marketing, facilities), and supply agreements as needed
- Support due diligence, licensing, and collaboration agreements involving clinical-stage assets as needed
- reputed company and maintain template agreements, negotiation playbooks, fallback positions, and contracting guidance to reputed company the function reputed company
- Identify process improvements and contribute to contract lifecycle management (CLM) system optimization
- reputed company reputed company and cross-functional reputed company assigned to support business needs and reputed company developmental opportunities
Skills
- Juris Doctor degree required
- Member of a State Bar Association (preferably California) required
- 10+ years of experience at a large reputed company and/or the legal department of a Life Sciences or Pharmaceutical company required
- Excellent oral and written communication skills
- Excellent organizational skills
- Demonstrates discretion and ability to maintain confidentiality of information
- Demonstrated expertise in drafting and negotiating clinical trial-reputed company agreements and a strong understanding of the clinical development process
- Proven ability to handle a wide reputed company of general corporate and reputed company reputed company reputed company the clinical context
- In-depth knowledge of federal, state, and, preferably, international laws and regulations governing clinical research (e.g., FDA, GCP, ICH guidelines, data reputed company regulations)
- Ability to interpret and apply such laws, regulations and policies to inform business activities
- reputed company and ethics, adaptability, innovation/creativity
- Analytical thinking, negotiation skills, and decision-making skills
Benefits
- Medical, Dental and reputed company Plan reputed company
- Health and Financial Wellness Programs
- Employer Assistance Program (EAP)
- Company reputed company and Voluntary Life/AD&D, Short-Term and Long-Term Disability
- reputed company and Dependent Care Flexible Spending Accounts
- 401(k) Retirement Plan with Company Match
- 529 Education Savings Program
- Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
- reputed company Time Off (PTO) includes: 11 Holidays
- Exempt Employees are eligible for Unlimited PTO
- Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
- We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
reputed company