What are the responsibilities and job description for the Associate Director / Director of Clinical Outsourcing position at Oruka Therapeutics?
About Us :
Oruka Therapeutics (Nasdaq : ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. We have raised nearly $500M since inception in February 2024 from top-tier investors and our first program is expected to be in the clinic in the first quarter of 2025. For more information, visit www.orukatx.com
As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.
Job Title : Associate Director / Director of Clinical Outsourcing
Location : Hybrid - Waltham, MA
Role Overview :
We are seeking a highly motivated Associate Director / Director of Clinical Outsourcing to join our dynamic, growing team as we work to set a new standard in treating chronic skin diseases. This role will be pivotal in helping support the clinical development and operational teams in their execution of the overall R&D strategy. This position reports to the head of clinical operations.
The ideal candidate will have a strong background in outsourcing and will bring relevant experience in strategic contracting and vendor management with success progressing programs. This individual has the ability to work collaboratively across the organization from R&D to G&A to drive value in terms of efficiency savings, cash flow improvement, creating and optimizing vendor relationships and facilitating stakeholder engagement. A track record of driving fast paced delivery and seamless management of multiple stakeholder needs is critical.
This individual must be a highly organized self-starter with a solid understanding of both general outsourcing principles in addition to clinical trial planning, budgeting, and the integration of activities and vendors necessary for efficient operations.
Our team values in-person collaboration, and we expect this role to work from our Waltham office at least three days per week. We're looking for someone who shares our passion for developing innovative medicines and is eager to make a meaningful impact.
Key Responsibilities :
- Develop and oversee RFPs, bid grids and budgets for third party vendors across a broad category of suppliers in support of R&D activities.
- Develop tools to allow for vendor comparison and selection across vendor types.
- Implement vendor governance tools, such as scorecards and KPIs, to track outsourcing quality and performance.
- Ensure outsourced activities comply with regulatory requirements (e.g., GCP, FDA, EMA)
- Partner with quality assurance to oversee audits of external vendors
- Responsibility for negotiating Master Services Agreements, development of study level contracts, change orders, PO generation, reconciliation and closeout activities.
- Collaborate across functions to optimize vendor relationships and ensure compliance with legal and financial guidelines including managing the accrual reporting process and associated tools.
Qualifications :
Experience : 10 years work experience in the industry with at least 2 years in a similar role required, preferably within an early stage public biotech / pharma company utilizing outsourced services. Proven expertise in vendor selection, contract negotiation and management.
Education : Bachelors degree (or higher)
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Job Location :
We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.
Salary Range for the Role
175,000-$230,000 USD
What We Offer :
Salary : $175,000 - $230,000
