Clinical Program Manager

2 weeks ago

Melbourne, Victoria, Australia Gilead Sciences Full time

For Current Gilead Employees and Contractors:
At Gilead we believe every employee deserves a great leader.

As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.


Job Description:


Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercialises innovative medicines in areas of unmet medical need.

Our heritage of science and innovation and the curiosity and passion of everyone who works here has enabled us to provide medicines that help transform standards of care for more than 30 years.

Gilead's therapeutic areas of focus include liver diseases, infectious diseases, inflammatory diseases and cancer.


Clinical Operations is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world.

In partnership with Clinical Research, Medical Affairs and Development Operations functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high-quality clinical data to support global registration and commercialisation of Gilead's products.


We have an exciting opportunity for an experienced Clinical Program Manager within the ANZ business to join a team of Clinical Operation members and focus on supporting trials within the therapeutic areas of Oncology and Inflammation.

Reporting to the Clinical Operations Associate Director, this position's key responsibilities will include:
Managing a team of 4 direct reports, fostering an inclusive and coaching environment to drive a high performing culture

  • May provide input into strategic and operational short
- and long-range therapeutic area / functional area plans as appropriate, including supporting alignment and communications to other team members upon implementation.

  • Acts as team leader and builder; providing guidance and oversight for the successful management of all aspects of clinical trials within designated program budgets and timelines.
  • Leads crossfunctional Study Management Teams (SMTs) and influences all relevant stakeholders.
Act as a Regional Lead on trials within the APAC region

  • Partners with crossfunctional teams to manage, adjust and revise project timelines and budgets as needed.
  • Communicates project status and issues and ensures project team goals are met in alignment with project decisions. Escalates issues as needed.
  • Participates in the development of all studyrelated documentation, including study protocols.
  • Participates in the selection and management of contract research organizations (CROs) / vendors, including development of requests for proposals (RFPs).
  • Anticipates obstacles and difficulties and implements solutions to achieve project goals, including risk assessment and mitigation strategies.
  • Resolves issues as needed within national and international regulations and guidelines.
  • Uses all available tools to track, oversee and communicate on program status to all key stakeholders.
  • Participates in and/or leads departmental or interdepartmental strategic initiatives.
  • As assigned, initiates, authors or otherwise contributes to standard operating procedure (SOP) development, implementation and training.
  • Responsible for Clinical Operations activities conducted by the affiliate that are required by local regulations and/or usual practice to support clinical trials.
  • Ensures team's work complies with established practices, policies and processes, and any regulatory or other requirements.
Advanced knowledge of one or more disease or therapeutic areas, essential to have experience within Oncology and Haematology

Have a strong track record of working within the Pharmaceutical industry

  • Complete knowledge of full cycle study management, from startup to closeout.
  • Thorough knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies.
  • Proven ability to effectively author clinical study and regulatory documentation.
  • Ability to lead and influence programs, projects and/or initiatives.
  • Strong interpersonal skills and understanding of team dynamics.
  • Proven ability to work successfully in a teamoriented, highlymatrixed environment.
  • Demonstrated effectiveness coaching, guiding and directing the work of others, effectively managing performance of others, and developing team capabilities, having managed and led teams previously
Ideally experience working with other countries in Asia within the Pharmaceutical industry

  • Demonstrated effectiveness in proactively managing c

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