Corporate Counsel, R&D

2 weeks ago

Basking Ridge, United States BioSpace, Inc. Full time
Job Details

Join a Legacy of Innovation 125 Years and Counting

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Summary

Independently handles legal projects, as assigned, and provides support to the Legal Affairs team. Will serve as the primary legal advisor point person for multiple clinical study programs, reviewing product and/or compound materials and drafting and reviewing contracts. Additionally, the person assigned to this position will perform research and advise clients on legal, business and regulatory issues. This position will primarily support the US R&D functions and may also support other functions (including, global functions within the US). Some coordination with outside counsel is anticipated, although it is anticipated that the majority of work will be performed without reliance on outside counsel.

Responsibilities

- Serves as the primary legal advisor to provide comprehensive legal support to cross functional teams for one or more clinical study programs which may include review of vendors agreements and policies, external training materials (e.g., CRO training materials), study protocols, subject recruitment materials, clinical study agreements, research collaboration agreements, informed consent forms or other documentation for clinical trials. Works under supervision to: (1) to respond and defend subject injury claims made against the company, and (2) assist cross functional teams during and in preparation for regulatory inspections, and (3) provide updates to senior management on various legal issues regarding clinical development programs.
- Prepares and provides legal review of Company documents such as contracts and correspondence (e.g., to regulatory agencies and clinical study sites) related to Company products and/or compounds, including providing legal guidance memos, both independently and for review, approval, and use by management and/or business customers. Independently negotiates contract language and other issues with third parties (vendors, etc.).
- Creates and/or reviews internal corporate policies, procedures, training materials and/or instructions, as assigned under the supervision of their management.
- Participate as a team member providing legal guidance on several key legal and business initiatives, as assigned, and provides Legal Affairs colleagues and assigned business customers, when requested, with updates regarding same.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)

- Bachelor's Degree from 4-year College or University of recognized standing required
- JD from Law School of recognized standing, and Bar Admission in NJ (direct admission or eligible for limited in-house licensing in NJ) required

Experience Qualifications

- 4 or More Years post-law school experience required
- 1 or More Years pharmaceutical or biotech industry experience, particularly in contracting and FDA regulatory issues preferred
- 1 or More Years prior experience on specific business customers within pharmaceutical industry (e.g., IT, Medical Affairs, Sales/Marketing, Managed Markets, Pharmacovigilance, Supply Chain, Compliance, Quality Assurance, pharma-specific litigation issues, promotional brand review, etc.) preferred
- Relevant in-house corporate and/or litigation experience. Experience in oncology therapeutic area is a plus preferred

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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