Associate General Counsel (Commercial)

Associate General Counsel (Commercial)

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 commercial-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.

What you'll do

Summary: Reporting into our SVP, Legal, the Associate General Counsel will lead the commercial legal function with primary responsibility to support our first U.S. product launch. This individual serves as a trusted strategic partner and provides practical, timely and business-savvy legal advice to the Commercial (Sales, Marketing, Market Access), Medical Affairs and Patient Support functions. This role is the subject matter expert (SME) on U.S. healthcare laws, FDA promotional regulations and industry codes to enable legal and compliant pre-launch, launch and ongoing commercial and medical activities. This role partners with and may oversee Compliance to ensure that the Company’s U.S. compliance program remains risk-based, fit-for-purpose and aligned with our corporate values, while supporting cross-functional teams through advisory responsibilities, training and policy development. The ideal candidate will combine a strategic and seasoned mindset with hands-on tactical and operational excellence.

Who you are

Location and Travel: role can support remote-based candidates. Travel expectations: up to 15%.

Requirements & Qualifications

• Significant experience providing strategic commercial legal support within the biotechnology or pharmaceutical industry, including FDA regulatory experience related to promotions, advertising, and market access.
• Demonstrated ability to partner with Sales, Marketing, Market Access, Medical Affairs and Patient Support teams to enable compliant pre-launch, launch and ongoing commercial activities.
• Strong knowledge of U.S. healthcare laws, FDA promotional regulations, and industry codes.
• Experience overseeing or collaborating with Compliance to maintain a risk-based, fit-for-purpose U.S. compliance program.
• Proven ability to deliver practical, timely, business-savvy legal advice and to operate as a trusted strategic partner.
• Strategic thinker with hands-on, tactical and operational excellence.
• Ability to work in a collaborative, cross-functional environment and influence without authority.

Benefits & Perks

Travel: up to 15% and remote-based work options. (Additional benefits not listed in the provided content.)

Tech Stack & Tools

Not specified in the provided content.

Team Description

Leads the commercial legal function and collaborates with Compliance to support cross-functional teams across Sales, Marketing, Market Access, Medical Affairs and Patient Support.