Senior Manager, Clinical Project Management, Global Health Research

Eisai

  • Cambridge, MA
  • Permanent
  • Full-time
  • 1 month ago
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.

The Position

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re an international pharmaceutical company dedicated to provide solutions in global health, neurology and oncology.

Eisai’s Global Health Research team is developing more than a dozen new medicines for diseases with devastating burdens in the developing world. These efforts are focused on malaria, tuberculosis and the neglected tropical diseases, and more recently have expanded to combat global pandemics. All our therapeutic programs are conducted in collaboration with prominent academic and non-profit organizations. Highlights from the advanced portfolio include a pivotal clinical trial in Sudan for a new mycetoma therapy, and a Phase II clinical trial in the Peruvian Amazon for a new malaria medicine.

Eisai is seeking a motivated, energetic Senior Clinical Manager to join a team of mission-driven drug developers and contribute to the creation of new medicines for Global Health. This position will spearhead management of global health clinical studies in multiple phases, including supply of study materials, outsourcing to CROs, contracts and budgets, and regulatory document filing. In addition, the Senior Clinical Manager will support project management of late preclinical programs. This is a highly collaborative role that will foster clear, consistent and productive communication between Eisai, external partners and service providers to enable successful advancement of novel therapies. This is an exciting opportunity for a motivated individual with agility to work on a high-impact global health portfolio.

Key Responsibilities

Lead to development of clinical plans in close collaboration with internal and external members of the project team, including safety, clinical pharmacology, DMPK and regulatory functions.

Manage all aspects of clinical study execution from start-up to close-out activities, assuring adherence to intended timelines and compliance with international GCP guidelines/regulations and SOPs/SWPs.

Manage all aspects of outsourcing to CROs and service providers to ensure successful conduct of the clinical trial: negotiations and contracting, monitoring daily study activities to ensure data integrity and quality, budgeting and invoicing, and provider evaluation. Coordinate with other departments (e.g. Finance, Legal) as needed.

Support project management of late preclinical programs to efficiently advance to clinical introduction: manage project plans and timelines, budgeting, CRO engagement and contracting activities. Coordinate a multidisciplinary project team including external collaborators.

Identify opportunities for improvement and lead implementation of new processes and solutions; contribute to clinical strategy of the Global Health Research team.

Profile

Bachelor’s degree in biological science, nursing, pharmacy or equivalent as a minimum; advanced degree and/or certification preferred.

Minimum 5-7 years experience managing clinical studies, including experience in multiple phases and all key aspects of clinical trial management. Must have well-grounded experience in drug development concepts (data driven decision making, functioning of project teams/sub-teams, development of protocols, clinical study reports etc.) and sound understanding and experience of regulatory requirements.

Extensive experience managing CROs and service providers for clinical studies.

Excellent project management skills, including budgeting, contracting and negotiations, timeline management and team coordination.

Infectious disease experience preferred; experience with tropical diseases and/or developing countries is a plus.

Thorough knowledge of GCP/ICH Guidelines and Regulations.

Demonstrated ability to identify emerging challenges/risks and collaboratively champion solutions within a multi-disciplinary drug development team.

Team player able to form strong cross-functional relationships, with excellent communication skills and ability to influence/persuade others.

Able to work effectively with minimal supervision; proactive and a self-starter.

Intellectually curious and interested in diseases afflicting the developing world; motivated to make a lasting contribution as a key member of the global health team.

Able to manage competing demands and shifting priorities while working across multiple projects.

Excellent written and oral communication skills.

Excellent analytical and problem solving skills with an eye for detail.

Values diversity and compassion, and embraces a multicultural environment.

High ethical behavior, whether dealing with colleagues, vendors, patients or physicians and to maintain Eisai’s human healthcare (hhc) policy is a requisite.

Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

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