Director, Clinical Monitoring Strategy

Oruka Therapeutics•Waltham, MA

9h•$213,000 - $240,000•Hybrid

About The Position

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. 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. We are seeking an experienced and highly motivated Director of Clinical Monitoring Strategy and Optimization to provide strategic and operational leadership for clinical monitoring activities across our development programs. This individual will play a critical role in building and scaling clinical operations infrastructure within a fast-paced emerging biotech environment. The successful candidate will oversee CRO monitoring performance, ensure high-quality execution of clinical trials, and contribute to the development of monitoring processes, vendor oversight strategies, and inspection readiness activities. This role requires a hands-on leader who is comfortable operating both strategically and tactically in a lean organization. This role will involve extensive regional and national/international travel (up to 80%) to clinical sites and vendors as needed to support training, study visits, oversight of staff and relationship building.

Requirements

Bachelor’s degree in life sciences, nursing, or related discipline.
10+ years (Director) of clinical operations experience within biotech, pharmaceutical, or CRO environments.
Significant experience overseeing clinical monitoring activities in interventional clinical trials.
Capable of presenting and training audiences of varied backgrounds, including PIs, Sub-Is, Study Coordinators and other site staff.
Strong knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements.
Experience managing CROs and external vendors.
Demonstrated ability to work effectively in a small, fast-moving biotech environment.
Excellent communication, organizational, and problem-solving skills.
Extensive domestic and international travel as needed (approximately 60-80%).

Nice To Haves

Advanced degree (MS, MPH, PharmD, PhD, or RN) preferred.
Experience in immunology, dermatology, rheumatology, or oncology.
Experience supporting NDA/BLA-enabling studies and regulatory inspections.
Experience implementing risk-based monitoring strategies and oversight models.
Prior people management experience.
Strategic thinker with strong execution skills
Comfortable with ambiguity and rapid change
Hands-on and solutions-oriented
Strong collaborator and relationship builder
High attention to detail and commitment to quality
Ability to influence cross-functional teams and external partners

Responsibilities

Lead and oversee clinical monitoring activities for Phase 1–3 clinical trials conducted globally and/or domestically.
Serve as the internal expert for monitoring strategy, site management, and risk-based monitoring approaches.
Provide oversight and management of all vendors involved with clinical monitoring to ensure quality, timelines, and budget adherence.
Develop metrics to oversee monitoring progress including central monitoring performance and protocol deviation management.
Drive the development of the clinical monitoring plan, annotated monitoring visit reports and all training materials for CRAs.
Identify Key Risk indicators for studies at the investigative site level and their associated oversight.
Contribute to inspection readiness activities and support regulatory inspections and audits.
Participate in or lead Site Qualification or Initiation visits as needed to build site relationships and monitor CRA performance.
Help build scalable clinical monitoring infrastructure appropriate for a growing biotech company.
Develop and refine SOPs, work instructions, templates, and monitoring processes.
Drive continuous improvement initiatives focused on quality, efficiency, and operational excellence.
Implement and optimize risk-based monitoring methodologies and centralized monitoring approaches where appropriate.
May directly manage CRAs and/or Clinical Trial Managers as the organization grows.
Mentor junior clinical operations staff and contribute to team development.
Foster a collaborative, accountable, and quality-focused culture.