Corporate Counsel, Clinical Contracts

About the company

The company Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At the company, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. The company’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

The company’s team is inspired to touch and help change lives through the company’s clinical studies in the field of oncology. The company has multiple global Phase 3 clinical studies, including:

Non-small Cell Lung Cancer (NSCLC)

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HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.

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HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

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HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

Colorectal Cancer (CRC)

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HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). The company is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Overview of Role

The Corporate Counsel, Clinical Contracts is responsible for supporting the review, negotiation, and execution of company contracts across multiple departments. This position supports the Legal Department and partners with clinical, quality, medical affairs, finance, research & development, HR, IT and other internal clients from other departments to draft and negotiate contracts that protect the company from risk, support company business objectives, and ensure compliance with company guidelines.

Role and Responsibilities

• Collaborate with attorneys and other legal staff in other practice areas to proactively identify and address key legal issues for the business teams.

• Draft, review, analyze and negotiate clinical related contracts, including clinical trial agreements (including ancillary agreements, such as clinical study service agreements, quality agreements, and pharmacy and radiology agreements), investigator sponsored studies (ISTs), collaboration and development agreements, sponsored research agreements, and agreements with contract research organizations (CROs). In addition, may draft and negotiate consulting agreements, master services agreements and related statements of work, promotional speaker bureau agreements, vendor and service contracts and related work orders, IT software license agreements, HR benefit and contractor agreements, leases, and confidentiality or non-disclosure agreements.

• Liaise between the internal business units and external parties, ensuring that all legal and contractual matters are addressed efficiently and promptly; escalate matters, as necessary, to reduce company risk and help ensure company business objectives are met.

• Promptly respond to complex inquiries regarding contract obligations and revisions

• Identify risks and issues, propose alternatives that meet company business objectives while also reducing company risk

• Reviews and tracks in-process and on-going agreements

• Supports company employees regarding the Contract Management process

• Interacts with Intellectual Property Counsel to ensure appropriate handling of intellectual property issues in agreements

• Interacts with Regulatory Counsel and Compliance to ensure appropriate handling of regulatory/compliance issues in contract matters

• Interacts with Quality Assurance to ensure appropriate handling of quality matters.

• Prepare template agreements, modify existing templates and prepare unique agreements as required

• Ensure clear and prompt communication with company employees, and outside parties regarding status of, or issues in, contracts

• Handle miscellaneous legal tasks or special assignments on an as-needed basis

• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills

• Juris Doctorate from an accredited law school, and admitted to a US state bar in good standing

• Minimum of 5+ years of major law firm and/or in-house experience with a pharmaceutical, medical device, or healthcare company, with a minimum of 2+ years reviewing and negotiating Clinical Trial Agreements (U.S. and ex-U.S)

• Precise drafting and strong legal analysis skills, and knowledge of the regulations and statutes and industry guidelines impacting pharmaceutical research, development and commercial contracts, including data privacy

• Proficient with Word and have a working knowledge of Excel and Microsoft Access

• Excellent written and oral communication skills; ability to work effectively and efficiently with all levels of management and personnel

• Strong organizational and planning skills and meticulous attention to detail

• Self-starter with the ability to work independently as well as collaboratively in a team environment

• Ability to handle competing priorities in a fast-paced environment and exercise sound commercial and legal judgment

• Must be flexible due to rapidly changing business environment for a growth company

This is the pay for this position

Pay Transparency

$158,000 — $185,000 USD

Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

The company does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact the company’s Talent Acquisition team at  [link for members]  to obtain prior written authorization before referring any candidates to the company.

The company Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.