**** This position is open to candidates in New York, San Diego or Remote locations. ****
At Intercept, our mission is to build a healthier tomorrow for patients with progressive non-viral liver diseases. Intercept's lead product, obeticholic acid (OCA), is a first-in-class farnesoid X receptor (FXR) agonist marketed under the brand name \"Ocaliva®\" in the U.S., EU and Canada for the treatment of patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. Ocaliva® was the first medication to be approved for PBC in over twenty years, and sales continue to grow more than four years after its initial approval in 2016.
Intercept has also established the leading clinical development program in advanced fibrosis due to nonalcoholic steatohepatitis (NASH), a disease that impacts the lives of millions of people in the U.S. alone. Currently, there are no available treatments for NASH, and the REGENERATE study of OCA remains the only Phase 3 trial to have generated positive results in the disease. A second Phase 3 trial, REVERSE, is evaluating OCA in patients with compensated cirrhosis due to NASH, with results expected in 2021.
People at Intercept are passionate about patients. You'll see their photos lining our walls and hear their stories in town halls. We're equally passionate about our team and ensuring each member reaches their potential. We brave new challenges together. That's how we find better ways to get things done and break down barriers. It's also how we make it fun to work here.
At Intercept, we foster an environment that celebrates creativity, collaboration and mutual respect. We never hesitate to lean on our teammates and work together. Our relatively small size means you partner with accessible leaders who know you by name. This brings accountability and growth, which all add up to more opportunities to learn something new every day. A strong commitment to diversity, equity and inclusion is engrained in both our culture and our business. For self-motivated leaders who are ready to make a difference in the lives of patients, Intercept is a great place to be.
As Intercept continues to build its position as the leader in progressive non-viral liver disease, we are seeking a Manager, Clinical Supplies. This motivated individual will join our Product Development department to manage Clinical Supplies for global clinical studies.
The successful candidate must be able to perform each of the following satisfactorily:
- Manage the labeling, distribution, returns, reconciliation and destruction of supplies to support global clinical studies at all phases of development.
- Interpret clinical study protocols to determine drug supply forecast and inventory requirements.
- Design, configure, and review IRT systems for drug supply management, accountability, and randomization of global clinical studies.
- Generate labels that comply with global regulatory agencies for investigational new drugs.
- Provide interpretation of regulatory guidance documents, regulations and directives and advising regarding their applicability and impact on internal labeling programs.
- Manage batch record review and batch release of labeling activities to support clinical supplies.
- Manage internal and third party deviations, customer complaints, and change controls to support cGMP labeling and distribution activities.
- Participate in the selection, evaluation and approval of third party contractors for packaging, labeling and distribution activities.
- Partner with other departments to identity, mitigate and subsequently resolve compliance and quality issues.
- Represent product development in interdisciplinary and technical project teams.
- Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
- Drive the spirit of \"ONE Team\" across all functions by supporting a team approach to focus on our patients and customers as our top priorities
- Make Intercept a truly desired place to work
- Ensure adequate documentation processes and systems are available and followed for labeling, distribution, returns, reconciliation and destruction of clinical trial materials activities (SOPs / Protocols review /approval).
- Set up internal processes and generate SOPs for clinical labeling, distribution, returns, reconciliation, and destruction activities of clinical trial materials.
- Support product development and QA in ensuring an acceptable outcome of all audits and inspections, especially those by government agencies, as they pertain to labeling and distribution practices.
Experience and Skills
- Bachelor's Degree in scientific discipline preferred
- Experience managing clinical trial material packaging, labeling and logistics preferred
- Minimum 3 years of applicable experience in the pharma/biotech industry with at least 1 year of direct clinical supply management experience.
- Strong knowledge of current Good Manufacturing Practices (cGMP) and relevant regulatory requirements (e.g., US, European, and Latin America)
- Strong understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the labeling context is essential.
REQUIRED KNOWLEDGE AND ABILITIES:
- Demonstrates strong teamwork in a multidisciplinary environment.
- Effectively presents development plans and strategies to various audiences and writes clear and concise summaries for reports and regulatory documents.
- Ability to effectively organize and prioritize tasks to achieve established deadlines
- Ability to work effectively in cross functional environment
- Strong verbal and written communications skills
- Learning agility and 'scalability' to take on increasing responsibility as Intercept grows
- Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity
- Ability to have fun and thrive in a growing, diverse and inclusive work environment