Director - Clinical Development Science

4 weeks ago

Bengaluru, India Elanco Full time

At Elanco (NYSE: ELAN) – it all starts with animals

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose – to advance the health of animals, people, the planet and our enterprise.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today

Position Title:

Director

Clinical Development Sciences

Supervisor Title:

Senior Director

Strategic Alliance Management and Disease Model Development

Job Level:

M2

Position Type:

Full Time

Job Function:

IAC, Global Clinical Development Sciences

Location:

Bangalore, Karnataka, India

Position Description:

This is a supervisor position providing functional and leadership support for clinical development sciences (CDS) including global scientific writing, literature searches, clinical document management, study master file compilation and monitoring, and model development. Additionally, this position will shape and support study management activities that occur within India. This position will support scientific processes that drive quality and timely delivery, as well as develop capabilities that align with global clinical development and operational needs.

This position will closely collaborate and communicate with global R&D functions including other functional leads, research scientists, study investigators, veterinary clinicians, biostatistics, regulatory affairs and quality assurance ensuring commitments are met with quality and speed. This is a local leadership position representing R&D at the site-level and will participate in other global leadership forums as required.

Functions, Duties, Tasks:

Responsible for overall planning and execution of scientific writing/literature search support and document management (R&D) to be delivered out of IAC ensuring quality, speed and value. Implement expansion of CDC capabilities into compilation and monitoring of study master file as well as local study management activities. IAC scientific capabilities will also be integrated to support model development needs across the global organization.Develop operational strategies at the local level that will address the needs of the global business.Responsible for 5-50 headcount and support R&D through organic growth as demand increases.Run metrics for key performance indicators.Responsible for high level of team engagement and provide leadership to the team.Foster staff career growth and development by providing timely and constructive feedback.Build partnerships across R&D to identify value propositions for CDS IAC.Represent CDS IAC and collaborate with the quality organization for site level quality initiatives as well as corporate level audits and inspections.Understand current industry standards for scientific writing, document management and animal health regulatory guidelines.Demonstrate high levels of adaptability, flexibility, and learning agility.Provide data in a timely fashion to ensure accurate tracking of project budgets and timelines.Ensure appropriate levels of quality control, scientific integrity and animal welfare in all activities.Supervise resources including new hires, performance issues, terminations, and contractors.

Minimum Qualification (education, experience and/or training, required certifications):

Advanced degree in life sciences, veterinary medicine, biochemistry, pharmacology.10 years of relevant experience in the clinical domain.Fundamental understanding of the clinical development space with preference for studies involving animals. Additionally, basic document authoring and literature reporting as well as document practices and systems, , Veeva, and SharePointStrong GXP knowledge, in particular GLP, GCP and GMP.Good written and verbal communication skills.Good people management skills.

Additional Preferences:

Ability to solve complex problems.Sound understanding of operational Regulatory and R&D principles.Ability to communicate logically and technically.Organizational planning skills, ability to manage competing priorities and flexibility to change.Ability to work additional hours as required and work with staff in irregular time zones.

Other Information:

You will be part of the clinical development sciences team.You will work with groups in the USA, Australia, and EU region.You will manage Elanco operational requirements locally and ensure implementation of policies and procedures.You will be required to directly interact with stakeholders that are on global scientific teams.

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