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 Senior Director of Clinical Operations responsible for overseeing the implementation and management of early and late phase clinical studies.
This position will partner with clinical development scientists and other development team members, contract research organizations, and consultants to ensure the successful, cost-effective, and timely execution of early clinical studies (including proof-of-concept study). Responsibilities will also include managing across clinical sites in coordination with CROs, tracking and ensuring projected enrollment, and coordinating sample analyses and data management activities. Expectations include managing the conduct of clinical trials that meet the business and product development goals of the company.
The Senior Director will act as the Operational Team Leader for co-ordination and management of a program of clinical trials and participate in the Clinical Development Team meetings to provide expertise in clinical operations. The Senior Director may also be required to be the Study Team Leader for large complex studies, and mentor more junior members of the clinical operations team.
The successful candidate must be able to perform each of the following satisfactorily:
- Oversee and manage/matrix-manage clinical team in U.S. and Europe (other worldwide, as necessary) to ensure alignment of activities with study/project timelines and to provide overall oversight of activities requiring GCP compliance.
- Work with project management to identify project objectives, identify potential obstacles and propose innovative solutions, and ensure adequate resources are implemented to ensure successful completion of the project.
- Work with Regulatory Affairs to manage communication with pharmacovigilance contract organization.
- Oversee studies managed by external CROs.
- Attend Operational Management Team on behalf of program.
- Manage external resources such as consultants and/or paid advisors.
- Coordinate vendor meetings and review vendor documents (e.g., manuals, Master Service Agreements, contracts) for adequacy.
- Develop project plans to include timelines and milestones.
- Prepare clinical documents (e.g., study reference manuals, documents to be submitted to Regulatory agencies or ethics boards), Standard Operating Procedures, guidelines, and departmental policies.
- May identify and assist in departmental training requirements including internal and external operations.
- Provide clinical content input to Regulatory and Safety interactions and documents.
- Communicate directly with senior management regarding progress of the project.
- Supervise direct reports and manage staff work and resource allocation.
- Other duties and responsibilities as assigned.
- 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
Experience and Skills
- BS, BA, RN, and 20 years of Clinical Research experience; MS, PharmD degree and 15 years of Clinical Research experience; PhD, MD and 10 years of Clinical Research experience preferably in biotechnology / pharmaceutical industry.
- Minimum of 10 years of experience in Clinical Operations, preferably with global trials; minimum 4 years of experience in a leadership role preferred.
- Understanding of working in a Matrix organization.
- In-depth experience soliciting CRO and key vendor proposals, critically evaluating competing proposals, negotiating key terms, and selecting/initiating these relationships.
- In-depth experience with drug development processes is required.
- Experience interacting directly with clinical sites is required.
- Experience in review/writing of clinical protocols, study manuals, case report forms, and informed consent forms is required.
REQUIRED KNOWLEDGE AND ABILITIES:
- Ability to present technical and business aspects of projects.
- Forward-thinking and creative with high ethical standards; team player with leadership skills.
- Able to work in a fast-paced environment with drug development professionals.
- Well organized and self-directed.
- Strong interpersonal skills with an ability to communicate to people at all levels of an organization.
- Knowledge of GCPs, ICH guidelines and FDA regulations. Familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements is a plus.
- Understanding of the principles of project management and proven ability to lead a project team.
- Prior experience with managing large multi-center studies with a keen understanding of all aspects of Clinical Operations, including: clinical trial design, study implementation/start-up activities, CRA and site management, data management (to database lock and data analyses).
- Must possess a professional demeanor and effective communication capabilities for collaboration with others in a multi-disciplinary group.
- Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures. Must be focused and able to meet tight timetables.
- Adaptable and able to work in environment where priorities are constantly changing.
- Ability to effectively present ideas and document concepts in writing and orally.
- Excellent computer literacy with working knowledge of PCs, Windows and Microsoft Office applications.
- Ability to travel, in some cases, internationally. (Average travel expectations:
- Should have both interest and experience in medical writing (e.g. protocols, study reports) and in analyzing data during and after the conclusion of studies. Must be prepared to act in Clinical 'research' as well as 'operational' roles.
- 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.