Senior Medical Director, Pharmacovigilance and Safety

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:  Senior Medical Director, Pharmacovigilance and Safety        

Location: Remote or Hybrid if located near Waltham, MA or Menlo Park, CA office and will be required to be in-office in 3 days/week.          

Role Overview:

The Senior Medical Director of Pharmacovigilance and Safety plays a key role in the oversight and strategic direction of drug safety and pharmacovigilance activities in our clinical studies.  This role will help ensure high-quality data generation to support the safety and efficacy of our pipeline products. The role will manage medical safety activities and processes, oversee our pharmacovigilance vendor(s), and ensure continuous assessment of safety profiles and benefit-risk of investigational compounds.   The Senior Medical Director collaborates closely with internal and external stakeholders to ensure compliance with regulations and guidelines, contribute to safety regulatory documents, and protect participant safety.

Key Responsibilities: 

Safety Leadership and Risk Management: 

• Responsible for safety surveillance and risk management activities including but not limited to: medical review of Individual Case Safety Reports (ICSRs), routine review of safety data, and ongoing review of assessments for safety signals or in response to Regulatory Authority requests.
• Provides medical safety input into the design and conduct of clinical trials
• Plans and interprets safety data analyses, prepare and present safety data summaries to internal and external stakeholders
• Acquire and contribute knowledge of relevant drug class and/or competitor safety issues
• Lead the development of safety surveillance strategy, identify potential clinical safety issues, and recommend appropriate risk mitigation measures
• Establish and maintain collaborative working relationships with all key stakeholders (e.g., clinical study teams, safety CROs, business partners) which require expert contribution to the development of the product safety strategy
• Accountable for risk management activities including preparation and maintenance of relevant sections of clinical trial protocols, IBs (including the reference safety information section), ICFs, DSURs, RMPs
• Proficient with safety surveillance systems and tools (e.g., Argus, MedDRA, Veeva Vault) 

Medical Expertise:

• Develop response strategies in collaboration with internal and external collaborators, providing medical-scientific input to regulatory documents for safety-related requests from health authorities and other external parties
• Contribute to regulatory authority submissions during the lifecycle of drug development
• Accountable for the safety components of study reports (i.e., CSRs), aggregate reports (DSUR, PSUR) and other regulatory documents.
• Provide insights and leadership and development of IDMC and Adjudication Committee Charters
• Consistently comply with all governing laws, regulations, standard operating procedures (SOPs) and other guidelines.
• Apply previous experience in safety data analysis, including analyzing trends and patterns in large datasets 

Required qualifications:

• Medical degree (MD/DO or equivalent) with completed residency
• Minimum of 6 years of safety experience within the pharmaceutical industry
• Strong expertise in global pharmacovigilance regulations and