The Role
Lead commercial legal function supporting the first U.S. product launch. Provide legal advice to Commercial, Medical Affairs, Market Access and Patient Support on FDA promotional rules, pricing, contracting, compliance (AKS, FCA), review promotional/medical materials, oversee outside counsel, develop policies, training, and support compliance program evolution.
Summary Generated by Built In
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.
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.
Location and Travel: role can support remote-based candidates. Travel expectations: up to 15%.
Key Responsibilities
- Serve as key legal partner and SME to commercial and medical teams
- Provide practical legal advice on pre-launch activities and launch strategy, including medical (e.g., MSL activities and programs), disease awareness, sales, marketing (brand messaging, activities and campaigns), marketing analytics, patient advocacy programs, advisory boards, incentive compensation for commercial personnel and other business activities
- Counsel market access on pricing, reimbursement, distribution and contracting structures; advise on payer engagement issues including PIE and FDAMA 114; draft and lead the development of market access and patient support agreements; advise patient support team on legal issues related to patient support and hub services
- Act as Legal representative reviewing content and messaging on Promotional Review Committee, Medical Legal Regulatory (Medical) Review Committee, Publications Review Committee, ISR reviews, grants and sponsorships committees and similar bodies
- Training of applicable personnel
- Oversee outside counsel; conduct and respond to diligence for financings, business development activities and the like as needed; and review other external corporate content such as press releases
- Provide thought partnership to Compliance to advise commercial, medical, and advocacy teams on compliance obligations
- Partner with Compliance to evolve the U.S. compliance program consistent with company size and scope and aligned with company values
- Partner with Compliance to coordinate training activities including legal and compliance responsibilities, ethics, policies and procedures
- Support development and enhancement of compliance policies and SOPs related to AKS, FCA, and industry codes
Commercial & Medical Affairs Legal Support
Compliance Program Support
Qualification Requirements
- JD required with 12+ years of relevant legal experience in the biopharmaceutical industry (biotech preferred)
- Deep knowledge of FDA promotional regulations, Anti-Kickback Statute, False Claims Act, OIG Guidance, and industry codes, and ability to stay current on evolving trends and enforcement
- Experience reviewing promotional and medical materials
- Ability to interpret and apply healthcare laws to complex business plans
- Experience supporting product launch planning and cross functional review committees (experience building for first US launch preferred)
- Strong business partnering skills with ability to balance risk and business goals
- Excellent communication skills
- Ability to manage multiple priorities in a fast-paced environment; comfortable working in a demanding start-up culture with evolving processes; flexible and able to adapt to new situations as the business demands
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. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized 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.
Skills Required
- JD required with 12+ years of relevant legal experience in the biopharmaceutical industry
- Deep knowledge of FDA promotional regulations, Anti-Kickback Statute, False Claims Act, OIG Guidance, and industry codes
- Experience reviewing promotional and medical materials
- Ability to interpret and apply healthcare laws to complex business plans
- Experience supporting product launch planning and cross-functional review committees
- Experience building for a first U.S. launch
- Strong business partnering skills and ability to balance risk and business goals
- Excellent communication skills
- Ability to manage multiple priorities in a fast-paced start-up environment
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The Company
What We Do
Orca Bio is a clinical-stage biotechnology company developing a pipeline of high precision allogeneic cell therapy products that are designed to safely replace patients’ diseased blood and immune system with a healthy one. Our manufacturing platform sorts donor blood with single-cell precision and a high level of purity and speed, enabling us to create proprietary, optimal therapeutic mixtures of immune and stem cells that have the potential to transform allogeneic cell therapy. Our talented team is driven by a passion for science and compassion for patients.
