Oruka Therapeutics - Executive Medical Director, Clinical Development
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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
• Strategic Leadership: • 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 • Clinical Trial Design and Oversight: • 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) • Medical Expertise: • Medical Expertise: • 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 • KOL engagement, advisory boards, and regulatory interactions as appropriate • Cross-Functional Collaboration: • 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 • People Leadership & Team Development: • 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
Benefits
• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity. • The anticipated salary range for candidates is $331,000 to $368,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states. • 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. • A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients. • Competitive salary and benefits package. • A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work. • Opportunities for professional growth and development.
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