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Associate Director, Clinical Operations

Job Description

COMPANY SUMMARY:

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 five 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 2022.

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.

POSITION SUMMARY:

As Intercept continues to build its position as the leader in progressive non-viral liver disease, we are seeking an Associate Director, 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 cross-functional 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. Expectations include managing the conduct of clinical trials that meet the business and product development goals of the Company.

CORE ACCOUNTABILITIES:

The successful candidate must be able to perform each of the following satisfactorily:

  • Functions as the Study Team Lead (STL) in managing the clinical operations team and cross-functional clinical trial team in the planning, execution and reporting of clinical trials
  • Manages external resources such as consultants, contractors, CRO's.
  • Responsible for managing study budgets including forecast and invoice approvals
  • 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 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.
  • Ensure all clinical activities are delivered in accordance with expectations, trial protocol, ICH/GCP guidelines and applicable SOPs and regulations (local/US/international)
  • May supervise direct reports and matrixed study team.
  • Other 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

QUALIFICATIONS:

  • Bachelor's or RN degree with a minimum of 8 years of biotechnology or pharmaceutical industry experience in clinical operations. Advanced degree is a plus.
  • Prior experience as a study manager or study lead at a biotechnology or pharmaceutical company required.
  • 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 issues is required
  • Experience interacting directly with clinical sites is required
  • Experience in reviewing 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
  • Strong interpersonal skills with an ability to communicate to people at all levels of an organization



REQUIRED KNOWLEDGE AND ABILITIES:

  • Knowledge of GCP, 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 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.
  • Able to work in a fast-paced environment with drug development professionals
  • Well organized and self-directed
  • 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: approximately 25%).
  • 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: Come Together, Be Yourself, Own the Solution, Embrace the Challenge, Keep Exploring.
  • Understanding the legal and compliance environment
  • Ability to have fun and thrive in a growing, diverse and inclusive work environment



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Associate Director, Clinical Operations

Morristown, NJ 07960
Full Time

Published on 06/14/2022

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