Associate Director, Clinical Outsourcing

Position Overview

• Location Type: Remote or Hybrid (Waltham, MA)
• Job Type: Full-time
• Salary: Not specified

Oruka Therapeutics is seeking an Associate Director, Clinical Outsourcing to manage vendor relationships and support business aspects of vendor agreements for clinical trials. The role involves vendor governance, selection, negotiation, budget management, and performance oversight, reporting to the Head of Clinical Outsourcing. The goal is to drive effective vendor management for high-quality clinical trial planning and execution.

Requirements

• Not specified

Responsibilities

• Lead Outsourcing and Vendor Management at a program level to support long-term outsourcing strategy in partnership with Clinical Operations leads.
• Manage the contract lifecycle for assigned programs in collaboration with finance and legal.
• Build partnerships with vendors to support long-term relationships.
• Develop thorough scope of work documents and expectations to ensure high-quality work and meet key deliverables.
• Build budget templates and negotiate rates with CROs to ensure fiscal responsibility and transparency.
• Manage corporate risk by working with legal to develop contracts that ensure services are completed with high quality and within budgets and timelines.
• Effectively communicate and cultivate excellent internal cross-departmental and external vendor relationships to enable advancement of clinical development programs.
• Assess Master Services Agreements for operational or business risk and negotiate improved language through MSA Amendments in partnership with legal.
• Negotiate final scopes of work, budget, and payment schedules with input from cross-functional stakeholders for clinical study vendors.
• Negotiate Clinical Trial Agreements (CTAs) and Site Budgets with Institutions in the United States and Canada.
• Partner with CROs to oversee CTA and Site Budget country template development and global negotiations with institutions.
• Track contracted to actual investigator grant budgets across all Clinical Programs.
• Work through complex contracting scenarios to support operational execution of dermatology trials.
• Generate Request for Proposals (RFPs).

About Us

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics for chronic skin diseases, aiming to provide patients with significant freedom from their conditions through infrequent dosing. The company is advancing a proprietary portfolio of potentially best-in-class antibodies targeting the core mechanisms of plaque psoriasis and other inflammatory diseases. Oruka has raised nearly $500M and expects its first program to enter the clinic in Q1 2025. Oruka is looking for passionate individuals to join its core team and contribute to building an engaged, inclusive, and positive company culture.

Application Instructions

• Not specified