Director, Legal Counsel
il y a 6 jours
Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered.
At AskBio, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease, and congestive heart failure. Our gene therapy platform includes Pro10, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.
We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain.
Our vision: Pioneering science to create transformative molecular medicines.
Our mission: Lead innovative science and drive clinical outcomes to transform people's lives.
Our principles:
- Advance innovative science by pushing boundaries.- Bring transformative therapeutics to patients in need.- Provide an environment for employees to reach their fullest potential.
Our values:
- Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.- Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.- Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.- Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.- Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.
**Responsibilities**:
- Serving as a strategic legal partner to diverse teams across the Company by providing timely, proactive, strategic, best-in-class legal advice and support, taking into account the global objectives of the organization.
- Proactively supporting operational functions within the Company, focusing on Clinical Development.
- Strategically drafting, negotiating, and consummating a broad range of complex agreements, including CRO service contracts, vendor agreements, license agreements, data sharing and data licensing agreements, investigator-initiated study contracts, regulatory and quality agreements, professional services agreements, confidentiality agreements, consulting agreements, and contracts with healthcare professionals.
- Reviewing, analyzing and keeping current on relevant legal developments affecting the pharmaceutical and biotech industries, including sunshine laws and other regulations affecting interactions with healthcare professionals. Providing updates to senior leaders and business clients on changes in legal developments affecting the pharmaceutical and biotech industries.
- Identifying, participating in and contributing to contract enhancement initiatives.
- Collaborating with the contracting team to assure timely, proactive, strategic and high-quality legal advice.
- Identifying key legal issues requiring attention from the Associate General Counsel as appropriate.
- Working collaboratively with a broad range of people and functions throughout the organization to develop and maintain strong working relationships across all functional areas to facilitate a partnering-based approach. Coordinating closely with compliance colleagues.
- Supporting a culture includes driving and fostering: (1) an agile, adaptive culture; (2) a value-based organization based on the Company’s objectives; (3) a culture of innovation, transparency and trust; (4) proactive identification/mitigation of risk in a balanced approach; (5) empowerment and engagement of the legal and compliance team members; and (6) a collaborative culture with close coordination with other members of the legal and compliance teams; and (7) a culture of compliance and good corporate governance.
Required Education and Experience
- Required Juris Doctorate degree and bar admittance to practice law in a relevant jurisdiction or foreign equivalent with at least 7+ years of professional experience in a law firm or corporate setting representing pharma, biotech or life sciences companies.
- Understanding of the legal issues affecting the pharmaceutical industry, with a particular focus on early-stage research and innovation and regulatory processes for prescription drugs.
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