Description:

A Clinical Stage Biopharmaceutical Company is in search of an experienced life sciences attorney to serve as the Company's Legal Counsel. This role will primarily support the Company's Research & Development (R&D) and General & Administrative (G&A) functions with contracts and legal guidance. The successful candidate will have the ability to work independently with minimal instruction under the supervision of the Company's Associate General Counsel & Data Protection Officer, to deliver high-quality work product and offer sound legal advice in a fast-paced environment and to appropriately balance risk mitigation with the business needs of the Company.

Essential Job Functions:

Review, draft, negotiate and provide guidance regarding a wide range of contracts, including services agreements, consulting agreements, confidentiality agreements and software agreements, primarily for the Company's R&D and G&A functions.
Review and negotiate contracts with clinical sites, investigators and other parties for the Company's U.S. and global clinical trials, including confidentiality agreements, clinical trial agreements, facility use agreements and electronic records access agreements.
Collaborate with the Company's Centralized Contracting & Outsourcing (CC&O) function and CROs to develop clinical trial agreement templates for the Company's U.S. and global clinical trials and related negotiation guidance documents.
Advise stakeholders on contract interpretation, compliance with laws and regulations, dispute resolution and other matters in a manner that provides practical legal advice while appropriately managing risk to the organization.
Review and provide guidance regarding patient informed consent forms and other clinical trial materials.
Support the Associate General Counsel & Data Protection Officer with compliance with data privacy laws.
Partner with CC&O and Senior Manager, Legal Operations to efficiently and effectively process, review, negotiate and approve contracts and to optimize contract processes.
Refine the Company's contract templates, guidelines, playbooks and processes to support the efficient review, negotiation and execution of agreements.
Monitor, analyze and provide guidance regarding developments in U.S. and foreign laws, regulations, court decisions and guidance documents applicable to the Company

Job Requirements:

Law degree and admission to at least one State Bar (required). Minimum 7 years of relevant work experience at a pharmaceutical/biotechnology company and/or at a large law firm, with extensive experience negotiating clinical trial agreements and other contracts.
Thorough knowledge of pharmaceutical/biotechnology industry, related agreements and applicable laws, regulations and guidelines, including FDA laws and regulations and ICH GCP.
Exceptional contract review, drafting and negotiation skills.
Finesse for clearly and effectively distilling and communicating legal issues and analysis to business partners.
Capacity to manage a significant number of projects simultaneously and to thrive in a dynamic and fast-paced environment.
Strong attention to detail and process.
Proven ability to work successfully both independently and as part of a highly collaborative team.
Ability to analyze and interpret legal issues and develop and implement appropriately responsive strategies and solutions.

The base range for this role is $220-000 - $294,000per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. A Clinical Stage Biopharmaceutical Company's compensation package also includes generous benefits, equity, and participation in an annual target bonus.

A Clinical Stage Biopharmaceutical Company's Values that are used for candidate selection and performance assessments: