Executive Medical Director, Clinical Development

Oruka Therapeutics•Waltham, MA

12h•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. The Executive Medical Director of Clinical Development plays a key role in leading the design, execution, and oversight of clinical trials at an asset level, ensuring high-quality data generation to support the safety and efficacy of our pipeline products. This role involves leading and developing a team and contributing to and influencing clinical development strategy across an asset, including study design, implementation, and data interpretation, while working cross-functionally to align clinical activities with overall development plans. The Executive Medical Director collaborates closely with internal and external stakeholders to ensure trial execution meets regulatory, scientific, and business objectives in a fast-paced environment. The role reports to the Vice President of Clinical Development.

Requirements

Medical degree (MD) ideally with board certification in a relevant specialty
Extensive experience in clinical research and development, including within the pharmaceutical industry with progression of career demonstrating clinical leadership
Proven people leadership experience, including managing and developing direct reports in small or growing teams
Strong understanding of clinical trial design, GCP guidelines, and regulatory requirements, ideally with Phase 2 and 3 clinical study experience
Excellent communication, leadership, and analytical skills
Demonstrated ability to contribute to and influence clinical strategy while driving hands-on execution
Experience working in a small or emerging biotech environment, with comfort operating in a fast-paced setting

Responsibilities

Drives the clinical development strategy for one or more assets
Identifies critical clinical development milestones and ensures team alignment and accountability toward meeting timelines
Provides leadership to the clinical team’s contribution to clinical study reports, key clinical documents, and regulatory submissions
Directly manages and/or mentors Medical Directors, Clinical Scientists and other team members as appropriate
Leads and contributes to the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods
Oversees the conduct of clinical trials, ensuring adherence to protocols and good clinical practice (GCP) guidelines, working closely with CROs and external partners to ensure efficient execution
Reviews and interprets clinical data to assess the safety and efficacy of the investigational drug, driving timely, data-driven decisions
Manages the clinical contribution to documents required during development (including but not limited to: Clinical Study Protocols, Investigator Brochures, Clinical Study Reports)
Provides deep medical and scientific expertise in the therapeutic area, disease state, and potential drug effects
Reviews clinical data to identify and analyze safety concerns and adverse events, working with the pharmacovigilance team on continual benefit-risk assessment
Stays current with relevant medical literature and clinical trial methodologies
Contributes medical expertise to external interactions, including KOL engagement, advisory boards, and regulatory interactions as appropriate
Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pharmacovigilance, pre-clinical and project management teams to ensure alignment between clinical strategy and execution in a fast-paced environment
Presents clinical data to internal and external stakeholders as appropriate
Leads and develops a high-impact team
Provides coaching, mentorship, and performance management
Fosters a culture of accountability, collaboration, and scientific rigor
Supports hiring and resource planning in partnership with leadership