Intercept Pharmaceuticals Senior Director, Quality Program Management in New York, New York
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 di¬fference in the lives of patients, Intercept is a great place to be.POSITION SUMMARY:
As Intercept continues to build its position as the leader in progressive non-viral liver disease, we are seeking a Senior Director, Quality Program Management, to serve as a key member of the Quality Leadership team, driving development and execution of departmental vision and strategy across the GxP organization. Reporting to the Chief Quality Officer, this individual will be responsible for the following core responsibilities:
- Liaise with executives across the company to identify and operationalize value driven projects within the Quality function to increase efficiency and effectiveness and reduce operational complexity and redundancy while positively impacting the company’s operational and regulatory risk profile* Collaborate cross-functionally to identify shared goals and transform them into action* Lead working teams to create durable and meaningful change aligned to company objectives
This is a highly visible position both within and external to the Quality function, requiring strong written, verbal, and presentation communication skills. The candidate must have a strong ability to translate technical, cross-functional, and regulatory concepts into stepwise and actionable messages suitable for C-Suite and shopfloor audiences. Strong interpersonal communication skills will ensure maximal impact through message alignment, retention and diplomatic influence. The Senior Director will work closely with CQO and Quality leaders to develop deep understanding and organizational wide ownership of Quality principles and processes to ensure consistent and compliant operations in pursuit of delivering novel therapies for non-viral liver disease.
The successful candidate must be able to perform each of the following with excellence:
- Partner with Chief Quality Officer, Quality Leadership Team and other cross-functional colleagues to translate vision and strategy into actionable strategic and tactical workplans that include compelling calls to action and result in achievement of organizational goals and sustainable improvement* Demonstrate strategic thinking while also having the capability to interact cross-functionally and manage day-to day operations of the group through leadership and effective interaction/influential skills* Influence, partner with, and lead cross-functional and technical teams in process and compliance improvement initiatives that have organization-wide impact* Analyze and model datasets to build and defend value cases* Develop presentations and other communications suitable for discussion with the Board of Directors and cascading through every level within the company* Analyze data and regulatory guidance to inform and influence development of functional strategy* Work with Finance department and cross-functional team to track project budgets and resourcing needs and proactively flag issues; participate in annual budget and forecasts* Interface with third-party vendors and suppliers as Intercept’s main point of contact and program manager for GxP projects as necessary* Ability to positively impact functional performance and company culture while driving a solutions-oriented mindset and openness for innovative ways of working* Mentor other Intercept personnel* Understand the legal and compliance environment and drive collaboration with Legal and Compliance teams* 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
- Bachelor’s Degree in Science or Mathematics required; advanced degree preferred* 15+ years’ experience developing, influencing, and executing on functional or corporate initiatives within the pharmaceutical or biotechnology industry* 5+ years previous experience in a Quality, Technical, Clinical, Operational or Consultative role leading teams and delivering exceptional results through influence and diplomacy; GxP experience preferred* Certifications in Quality, Six Sigma, or Project Management a plus
REQUIRED KNOWLEDGE AND ABILITIES:
- Advanced understanding of cGMP requirements in Clinical or CMC operations within the pharma/biotech industry* Ability to create communications using multiple platforms (MS Project, PowerPoint, Word, etc.) that are compelling and relatable to the audience* Ability to influence without having direct line responsibility* Ability to deliver projects or transformative initiatives within a fast paced, entrepreneurial, pharmaceutical development environment* Ability to lead small- to medium-sized teams* 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
Keyword: Senior Director, Quality Program Management
From: Intercept Pharmaceuticals