Senior Legal Counsel

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 Senior Legal Counsel is primarily responsible for drafting, and negotiating to execution key clinical collaboration agreements.  This position will also support other legal and contracting needs of the company. This position is within the Legal Department and partners with business development, clinical development, clinical operations, medical affairs, finance, research & development, and other internal clients from other departments to support company business objectives, protect the company from risk, and ensure compliance with company guidelines.

Role and Responsibilities

Draft, review and negotiate strategic clinical trial collaboration agreements, including related supply, delivery and quality agreements, with business development, research and development, and commercial partners.

Draft, review 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), sponsored research agreements, and agreements with contract research organizations (CROs). In addition, may draft, review and negotiate financing agreements, consulting agreements, master services agreements and related statements of work, vendor and service contracts and related work orders, IT software license agreements, and confidentiality or non-disclosure agreements.

Acts as the primary contact between internal business units, including the Business Development and Strategic Alliance team, and external parties, ensuring that all legal and contractual matters are addressed efficiently and promptly; escalate matters to the Chief Legal Officer or General Counsel, as necessary, to reduce company risk and help ensure company business objectives are met.

• Provide guidance and supervise other attorneys and paralegals in the legal department in the review and negotiation of contracts ensuring compliance with all Legal Department guidelines, policies and procedures

• Develop strong working relationships with functional groups and project teams.

• Promptly respond to complex inquiries regarding contract obligations and revisions.

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

• Reports the status of contracts to internal clients using established processes and updated processes as necessary.

• Actively seeks feedback and advice from IP Counsel, Regulatory Counsel, Commercial Counsel, and the Compliance Department to ensure efficient and appropriate handling of relevant issues in agreements

• Works 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 contract status and any outstanding issues

• Support due diligence activities during acquisition of assets as it relates to review and assessment of contracts.

• Provide training within the legal team and to other business departments as needed regarding contracting matters.

• 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 7+ years of major law firm and/or in-house experience with a pharmaceutical, medical device, or healthcare company

• Must have substantial prior experience as lead attorney for drafting and negotiating Clinical Trial Collaboration Agreements

• Prior clinical trial agreement negotiation and drafting experience (U.S. and ex-U.S.) with a pharmaceutical company

• Precise drafting and strong legal analysis skills, and knowledge of the regulations and statutes and industry guidelines impacting clinical trials, pharmaceutical research, development and commercial contracts, including data privacy (U.S. and GDPR)

• Proficient with Word and have a working knowledge of Microsoft Excel and Teams and experienced working with CLM systems and an ability to quickly learn new CLM systems.

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

• Able to handle multiple projects in a timely manner

• Experienced in handling due diligence with acquisition and/or divestitures

• Strong interpersonal skills including a strong sense of being a team player

• A keen understanding of business and the ability to diagnose legal problems and present positive, creative solutions and alternatives for management

• Strong organizational and planning skills and meticulous attention to detail

• Able to work independently while exercising initiative, flexibility and good judgment

• Works well under pressure to meet specific deadlines

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

This is the pay for this position

Pay Transparency

$203,000 — $242,563 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.