Job description
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients’ blood and immune systems with healthy ones, but also restore their lives.
The Director of Clinical Data Management will lead Orca Bio’s data management function, ensuring the highest standards of data integrity across all clinical programs. This role combines strategic leadership with operational expertise to deliver high-quality clinical data solutions that drive decision-making and regulatory submissions.
Responsibilities
Clinical Data Strategy & Operations:
Design and implement comprehensive clinical data strategies aligned with Orca Bio’s development objectives
Lead data management team in all aspects of clinical data management from study startup through database lock for multiple concurrent studies
Establish robust data collection, cleaning, and validation processes that ensure data integrity
Direct database design, build, and maintenance activities with a focus on quality and efficiency
Oversee query management, data reconciliation, and database lock procedures
Develop and implement data quality management systems that ensure accuracy and reliability
Establish data standards and processes based on CDASH/SDTM and other industry standards
Ensure compliance with ICH guidelines, 21 CFR Part 11, and other relevant regulations
Author and maintain SOPs and work instructions for clinical data management
Implement risk-based quality management approaches to data oversight
Team Leadership & Development:
Mentor and develop a high-performing clinical data management team
Provide direction, guidance, and quality oversight to team members, including consultants and vendors to achieve corporate goals and milestones
Establish clear roles, responsibilities, and career development paths
Partner with Biostatistics, Clinical Operations, Regulatory Affairs, and Medical Affairs
Cultivate a culture of excellence, innovation, and continuous improvement
Represent data management in interactions with regulatory agencies and external partners
Manage relationships with data management vendors
Manage departmental resources, timelines, budget, and performance metrics
Provide leadership in recruiting, training, and retaining top talent
Qualifications & Experience
- BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics or equivalent industry experience; advanced degree preferred
- 10+ years of progressive experience in clinical data management, with at least 5 years in leadership
- Comprehensive knowledge of clinical data management processes, systems, and regulatory requirements
- Proven experience with EDC systems (Zelta EDC preferred) and medical coding dictionaries
- Strong understanding of CDISC standards (CDASH, SDTM) and their implementation
- Track record of successfully building and leading data management teams
- Experience interacting with regulatory agencies regarding data management approaches
- Background in programming or technical data systems preferred
- Strategic thinker who can translate business objectives into actionable data strategies
- Strong interpersonal skills, including verbal and written communication, are essential
- Decisive problem-solver who can navigate complex challenges
- Collaborative partner who builds effective relationships across functions
- Entrepreneurial mindset; thrives in a fast-paced, evolving environment
- Flexibility in responding to change or business needs; desire to improve upon established processes
- Passionate about improving patient outcomes through rigorous clinical data practices
$200,000 - $225,000 a year
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations.
Who we are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
