Job Title: Associate Director, Clinical Operations
Location: London, United Kingdom
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. OCA, marketed under the brand name \"Ocaliva ® ,\" is approved in the U.S., EU and Canada for certain patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. Ocaliva ® was the first product to be approved for PBC in over twenty years and our team is proud to have been pioneers in providing the first second-line treatment option to patients with such critical need. The Ocaliva ® launch in 2016 also marked Intercept's successful transition from a development-stage company to a fully integrated commercial organization with continued growth.
In February 2019, Intercept reported positive topline results from the Phase 3 REGENERATE study of OCA in patients with liver fibrosis due to nonalcoholic steatohepatitis (NASH), which impacts the lives of millions of people in the U.S. alone. Currently, there are no available treatments for NASH, and Intercept is among the leading companies focused on the disease.
As Intercept continues to build its position as the leader in progressive non-viral liver disease and pursues its goal of bringing the first approved therapy to patients with NASH, we are seeking an Associate Director of Clinical Operations.
The Associate Director of Clinical Operations will, in partnership with senior management, implement and manage early and late phase human clinical studies to achieve the project and corporate objectives. This position will work with other development team members, clinical research organizations, and consultants to ensure the successful, cost-effective, and timely execution of 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. It is expected that he/she will manage the conduct of clinical trials that meet the business and product development goals of the Company.
Intercept currently outsources many of its clinical studies to CROs; therefore, the position demands a deep understanding of how to effectively direct and manage a CRO to perform the clinical studies, control study budgets, follow the contract requirements, and adeptly address issues affecting the conduct of the studies, all within the GCP environment and following Intercept's SOPs, policies, and procedures.
The successful candidate must be able to perform each of the following satisfactorily:
- Oversees and manages clinical team in U.S. and/or Europe (other worldwide, as necessary) to ensure alignment of activities with study/project timelines and to provide overall oversight of activities requiring GCP compliance.
- Identify project objectives, identify potential obstacles and propose innovative solutions, and ensure adequate resources are implemented to ensure successful completion of the project.
- Manages external resources such as consultants, contractors, CRO's.
- Coordinates vendor meetings and review vendor documents (e.g., manuals, Master Service Agreements, contracts) for adequacy.
- Develops Project Plans to include timelines and milestones.
- Prepares and/or supports preparation of clinical documents (e.g., protocols, 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.
- Will provide clinical content input to:
- Clinical Study Reports
- Regulatory interactions and documents
- Safety interactions and documents.
- Will communicate directly with senior and/or executive management regarding progress of the project.
- Supervise direct reports and matrixed study team.
- 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
- Bachelor's degree and 10 years or more Clinical Research experience in a Pharmaceutical, Biotechnology or CRO environment. A higher degree would be a plus.
- Experience in overseeing clinical monitors (CRAs), consultants, direct involvement in early phase human clinical trials would be a plus.
- In-depth experience (=5 years) managing small and large CROs, with a track record of successful completion of outsourced studies, including time to completion and within budget.
- Successfully managed large multinational or global studies
- Experience with evaluating CRO and vendor proposals, negotiating key terms, including budgets, and selecting/initiating these relationships
- Experience interacting directly with clinical sites is required
- Experience in review or writing of clinical protocols, study manuals, case report forms,
- and informed consent forms is required
- 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
REQUIRED KNOWLEDGE AND ABILITIES:
- Current knowledge of GCP, ICH guidelines and FDA regulations, as well as, familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements.
- Understanding of the drug development life-cycle and the rationale for different types of studies (Phase 1-4); experience in conducting and managing all types of studies.
- Understanding of the principles of project management and proven ability to lead a project team.
- Prior experience with managing large multi-center and multinational or global 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 effective verbal and written communication skills, with a professional demeanor for effective collaboration with others in a multi-disciplinary group at all strata of the organization.
- 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 a work 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:
- Experience in medical writing (e.g. protocols, clinical study reports) and in analyzing data during and after the conclusion of studies would be a plus.
- 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
- Understanding the legal and compliance environment
- Ability to have fun and thrive in a growing, diverse and inclusive work environment
This is a unique opportunity to join a dynamic organization, where you will enjoy a high level of autonomy and a chance to work in an innovative therapeutic area. Highly competitive remuneration on offer
To apply, please send a CV and cover letter no later than 10 th February 2021