Senior Director, Clinical Operations
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is an integrated specialty pharmaceutical company powered by a robust U.S. generics business and a growing branded business. The company has a noble and important mission: We make healthy possible.
Amneal is one of the fastest growing pharmaceutical companies in the U.S. and makes healthy possible through its diverse product portfolio that includes more than 200 generic product families, 5 marketed specialty products, and a portfolio of biosimilars, one of which has been filed with the FDA, one near-term filing opportunity and one in late-stage development.
Additionally, Amneal has impressive R&D capabilities that have resulted in one of the industry’s largest generics pipelines with 258 products filed or in development, one investigational drug to augment the Specialty business, and three biosimilars in various stages of development. Amneal’s product range spans injectables and steriles, topicals and transdermals, solid and liquid dosage forms and inhalation delivery systems.
Following its May 2018 combination with Impax Laboratories, Amneal is uniting its 6,500 employees worldwide - who are based across the US, India, and European locations – around its Learn, Lead, Succeed culture. This dynamic entrepreneurial culture encourages all employees to contribute, to work together and to balance strategic thinking/risk taking with the need to achieve results.
As integration work continues, the company is centralizing much of its leadership and key functions in the Bridgewater, NJ area, including the majority of the R&D function. This has resulted in the need to hire several key roles to ensure the continued growth of the business and bring the function together, thereby enabling operational efficiency, close collaboration within the team, and the sharing of ideas and values.
From a Specialty Pharma perspective, Amneal has two large Ph III studies underway for the treatment of Parkinson’s Disease and one Ph IV study for pediatric usage of Zomig. However, Amneal is aggressively continuing to pursue growth through its business development initiatives, and it is anticipated the Clinical Product Pipeline will be greatly expanded in the near future.
The Senior Director of Clinical Operations will be responsible to oversee the implementation and management of 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 clinical studies.
Responsibilities will also include managing clinical sites in coordination with CROs, tracking and ensuring projected enrollment, and coordinating sample analyses and data management activities. He/she will manage the conduct of clinical trials that meet the highest level of compliance.
In addition, the Senior Director will act as the Operational Team Leader for coordination and management of a program of clinical trials and participate in the Clinical Development Team meetings to provide expertise in clinical operations.
- Under the direction of the Vice President of Clinical, determine timelines, goals and objectives and ensure the successful execution of projects in a timely manner.
- Help with CRO selection process, including negotiating proposals and determining deliverables.
- Primary contact for CRO Clinical Trial Manager, Project Manager.
- Participate in meetings with CRO Executive Team when required.
- Coordinate discussions regarding project risks and strategies with CROs, including but not limited to recruitment, site issues, etc.
- Primary contact for CRO legal and Internal legal for Clinical Trial Agreement negotiation/ escalation and for Letter of Indemnification negotiation/escalation.
- Primary contact for CRO study start-up team for clinical site budget escalation.
- Back-up contact for site personnel if site personnel are unable to contact CRO.
- Approve Clinical Operations study documents provided by CRO.
- Internal lead on weekly CRO/Internal team communications and progress reports.
- Provide internal support with the monitoring of clinical trial data and issues associated with the data.
- Review CRO invoices against statement of work and ensure accuracy.
- Review CRO trip reports and seek clarifications on monitoring issues.
- Responsible for the oversight of project budgets and ensure adherence to the overall department budget as well as timelines.
Will provide clinical content input to:
- Regulatory interactions and documents.
- Safety interactions and documents.
- Will communicate directly with senior management regarding progress of clinical programs.
Professional Experience / Qualifications
- MS or PhD with experience working in a major CRO or Pharma company/industry.
- 8-12 years relevant experience in progressive roles.
- Comprehensive understanding of ICH/GCP requirements, principles, concepts, as well as industry standards and practices.
- In-depth experience overseeing CRO and key vendor proposals, critically evaluating competing proposals, negotiating key terms, and selecting/initiating these relationships.
- Experience interacting directly with clinical sites.
- 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.
- Able to work in a fast-paced environment with drug development professionals.
- 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).
- 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 an environment where priorities are constantly changing.
- Ability to effectively present ideas and document concepts in writing and orally.
- Should have both interest and experience in medical writing (e.g. protocols, study reports) and in analysing data during and after the conclusion of studies. Must be prepared to act in Clinical ‘research’ as well as ‘operational’ roles.
MS or PhD with extensive experience working with major CRO or Pharmaceutical industry.