Senior Specialist, Contracts Administration

The Senior Specialist, Contracts Administration is responsible for coordinating the contracting process for internal departments and external parties to develop and execute mutually acceptable agreements, primarily for the procurement of external professional services in an international pharmaceutical development organization.Provides project management and coordination to contracting processes/procedures, and other operational processes/procedures and projects as assigned.

Position Responsibilities:

• Initiates and coordinates a wide range of activities within existing standard contracting procedures and personally manages smooth execution of 200+ agreements annually, primarily for securing research and development arrangements from clinical research organizations, clinical trial sites, laboratories, universities, and professional services firms. Identifies and resolves potential issues as needed, and facilitates finalization of agreements.
• Drafts select types of agreements using standardized templates, which may include consulting agreements, confidentiality agreements, clinical trial site agreements, clinical lab agreements, SOWs, related amendments and change orders, and manages them to completion. Drafts and coordinates negotiation of select master services agreements, research collaborations, and material transfer agreements under the guidance of the Director, Contracts Administration and/or SVP, Business Development when needed, and manages them to completion. Manages workflow internally and externally to secure approvals and final execution of agreements.
• Serves as the primary interface for establishment of contracts, working directly with initiating department and contract owner, and interacting with other departments including Finance. Serves as liaison with internal and external legal counsel, as needed.
• Serves as a primary interface externally with third parties for execution of agreements, negotiating terms within established procedures and raising other issues for resolution as needed to ensure all aspects of the agreement are completed satisfactorily.
• Act as a lead system administrator for the contracts lifecycle management (CLM) system, ensuring that the CLM system is aligned with TB Alliance’s standard contracting process/procedures and up to date with current users and workflows. Maintains accurate and detailed agreement records in the CLM according to Contracts Administration’s standards for consistent record keeping. Create contracting reports from CLM for a variety of business needs upon request. Participate in periodic CLM database cleanup and modifications for improved system management.
• Participates in special projects as needed, such as participating with the Contracts Administration team in the development, implementation and daily use/adherence to internal contracting processes and procedures, updating and maintaining the contract template library, providing training to staff for use of CLM system and digital signature products, and other duties as requested to support a smooth contracting process for the organization.
• Ensure full adherence to applicable GxP and regulatory standards. Maintain alignment with annual GxP and regulatory training requirements.

Requirements:

• Three to eight years business experience in contracts administration in a clinical research & development setting, ideally in pharmaceutical, clinical research organizations, or other life sciences disciplines
• BS/BA in business or other relevant discipline.
• Working knowledge of a broad range of contract types, as stated above.
• Strong detail orientation, analytical and editorial skills, and ability to manage a large number of agreements simultaneously and autonomously.
• Strong written and verbal communication and negotiation skills.
• Savvy with learning and managing new technology software, especially CLM/contracting database management and use of digital signature products, ideally with a working knowledge of CFR 21 Part 11 compliance (as it relates to clinical contracts).
• Highly proficient in all MS Office products and Adobe Acrobat software.

Organizational Information:

TB Alliance is the recognized leader in accelerating the development and adoption of urgently needed new anti-tuberculosis (TB) drugs. Over the past five years, the transformative BPaL/M regimens have rapidly become the gold standard for drug resistant TB treatment, available at affordable prices in more than 150 countries and approved by regulatory agencies in 28 countries. Earlier, TB Alliance developed and introduced child friendly first line treatments endorsed by WHO and in use in over 123 countries reaching approximately 75% of the pediatric TB burden globally. Looking ahead, TB Alliance is poised to exponentially drive the field forward again in the foreseeable future with innovative compounds such as sorfequiline and telacebec through late-stage development, approval, and introduction of the next transformative regimen(s) in tuberculosis and adjacent disease areas.

TB Alliance is the proud recipient of the rigorously juried Prix Galien award for the life-changing impact on human health represented by the approval of pretomanid and the BPaL/M regimens Additionally, TB Alliance was honored twice by the Global Health Technology Coalition (GHTC) with their Innovating for Impact award; TB Alliance is the only recipient to have been recognized more than once in the history of this award.

TB continues to cause more deaths worldwide than any other infectious disease and disproportionately impacts marginalized populations as the disease is concentrated in the poorest of the poor, especially in lower- and middle-income countries. The World Health Organization (WHO) reports an estimated incidence of 10 million annually with active TB, of which 410,000 have drug resistant forms of the disease. In addition, over 1.5 billion people are infected with the TB bacillus, forming the reservoir for the development of active TB. Despite the high degree of unmet need worldwide, lack of commercial viability severely limits commercial interest in this disease area and treatment improvements are largely dependent on financial subsidization through public sector and private sector funding. TB Alliance was established to fulfill the need for greatly improved TB treatment, deploying a unique not-for-profit operating model characterized by a small core of highly experienced internal staff with capabilities extending across the spectrum of discovery, development, and delivery through to achieving widespread access to improved TB drugs. While US based, the TB Alliance has a global footprint with staff and partners in strategic locations throughout the world.

Compensation and Benefits:

As part of our overall compensation package, we offer a competitive salary, comprehensive health benefits, generous retirement contributions, and work/life flexibility designed to support employees and their immediate family. Starting salary is expected to be in the range of US$95,000 – $115,000; exact salary will be commensurate with skills and experience, adjusted to reflect local currency for candidates outside the US.

Terms and Conditions:

Position based in New York City, NY (US). Other relevant locations may be considered. A flexible, hybrid schedule is available; domestic and international travel will be required. TB Alliance is an Equal Employment Opportunity employer. This job description should not be construed to imply that these requirements are the only standards for the position. Other duties may be assigned. TB Alliance has the right to revise this job description at any time. TB Alliance is an "at will" employer and as such, neither this job description nor your signature constitutes any form of contractual arrangement between you and TB Alliance.