Sr. Contracts Manager
Responsible for the development and analysis of contractual relationships which includes but is not limited to drafting, negotiating, and finalizing contracts (clinical trial agreements/CTA) related to clinical trials and all clinical related agreements, including Master Services Agreements and other vendor agreements. Assists in and/or directs the development of terms and conditions. Provides specialized support to the clinical group in the planning, execution and control of contracts.
- Responsible for drafting, negotiating, and finalizing clinical trial agreements (CTA) with sites as they relate to various clinical projects, including vendor agreements
- Facilitates CDA & clinical trial agreement execution process and participates in site selection and startup activities
- Maintains positive and collaborative relationship with CRO partners. Assures coordination of outsourced contracting activities, and is the main point of contact for escalation
- Reviews informed consent forms to assure that these documents are consistent.
- Determines potential needs for contract amendments and manage amendment execution
- Assures that contractual terms and provisions are in compliance with corporate process, systems, and strategies
- Assumes responsibility for all aspects of document and metrics tracking.
- Adheres to SOPs, ethics and departmental compliance as determined by management as well as R&D, companies, and QA guidelines
- Contributes to improving processes and establishes refinements that reduce cycle time and improve efficiency in the initiation of clinical trial sites
- Collaborates with other members of the Contracts team to ensure proper dissemination and management of knowledge and to meet team goals and objectives
- Complies with requests from QA and auditors
- Proactively leads process improvements or other projects that enhance and streamline contract processes, systems, tools and other resources
- Reviews, analyzes and tracks in-process and on-going agreements
- Prepares and disseminates information regarding contract status, compliance, modifications, etc.
- Reports the status of contracts to internal clients using established processes
- Trains others group members on group/departmental processes and operational activities and customer specific processes
- Leads or supports internal audits of department processes and procedures
- 7 or more years of experience in life sciences legal or contracts management field
- Paralegal or Contract Management experience in Biotech preferred
- Strong contract language drafting and negotiation skills
- Proficiency with Word and working knowledge of Excel and Microsoft Access
HOW TO APPLY
To apply, please submit your cover letter and resume to email@example.com
Amunix is leveraging our expertise in precision protein engineering to enable the promise of T cell engagers in solid tumors. Our goal is to save cancer patients’ lives through the development and commercialization of breakthrough therapies that harness the immune system. We have invented XTEN, a validated therapeutic half-life extension technology. Our current focus is Pro- XTEN, a next-generation protease activated pro-drug platform, which enables selective activation of potent cancer therapies in the tumor microenvironment. This overcomes a common challenge facing potent immune system activators: on-target, off-tumor toxicity. Amunix’s two lead programs employ the Pro-XTEN technology to enhance the safety profile of T cell engagers. XPATs (XTENylated Protease-Activated T Cell Engagers) have the potential to make off-the-shelf therapies redirecting T cells to solid tumors a reality. Amunix is currently located in Mountain View, CA but is moving to South San Francisco in 2020.
Amunix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Amunix complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training.