Director, Development Contracts - R&D Operations

Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.

Position description:

The successful candidate will be responsible for the development, negotiation, review, and lifecycle management of contracts supporting Calico’s development and clinical projects.  This includes direct negotiation and oversight of the negotiation of clinical trial agreements, master service agreements, and scope of work agreements and related budgets in accordance with established timelines and budget. In close collaboration with business development, legal and finance, the successful candidate is expected to apply their knowledge of legal, regulatory and financial drug development requirements to create and/or drive the development of key documents templates and negotiation parameters, processes and additional infrastructure to support drug development contracts. The individual is expected to partner closely with clinical operations, project leadership, business development and management and additional functional leaders to understand the project or study priorities to support timely delivery of negotiated contracts and budgets.

Key Responsibilities:

• Directly negotiates and oversees the negotiation of clinical trial agreements and budgets
• Creates and drives the development of key documents including Clinical Trial Agreement (CTA) templates, clinical budget templates, Confidentiality Agreements (CDAs), negotiation parameters, in collaboration with the legal, finance, and other departments as necessary
• Provides direct oversight of Contract Research Organizations (CRO) with respect to CDA/CTA/budget negotiations; sets clear milestones, escalation steps, and triggers
• Maintains a working knowledge of third-party payer rules and Fair Market Value and applies this knowledge to budget negotiation/oversight
• Contributes to vendor selection and Request for Proposal (RFP) process including participation in vendor bid defenses and negotiation of vendor contracts/budgets
• As appropriate, holds vendor to quality expectations
• Review of Informed Consent Form (ICF) templates
• Adheres to Good Clinical Practices (GCP) and Good Documentation Practices (GDP)

Position requirements:

• BS/BA required with a minimum of 10 years’ experience including prior experience negotiating clinical development contracts in a biotech/pharma company

• Demonstrable knowledge of the current global and regional trends in clinical outsourcing and contracting as well as legal and regulatory environment as it relates to the pharmaceutical/biotech industry

• Knowledge of the drug development process with a deep understanding of the operational aspects of clinical development including a thorough knowledge of the clinical site contracting process
• Strong interpersonal skills to maintain positive working relationship with internal and external stakeholders
• Detail-oriented mindset with excellent verbal and written communication skills
• Ability to work independently while managing to multiple priorities
• A positive can-do attitude
• Must be willing to work onsite at least three days per week

Calico requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Calico will consider requests for Reasonable Accommodations.