Key tasks:

- Generate scenarios for alternative development pathways containing timeline and cost

- Facilitate effective information exchange across studies within the clinical program

- Proactive, close support of GCL in creation of Clinical Development Plan (CDP) and its constituent studies for in-house and co-development projects

- Deliver resource estimates (FTEs) in collaboration with functions for all roles contributing to the clinical development at the project / study level for Clinical Development Plan

- Provide external and internal cost overviews with cost of each study

- Collaborate on document preparation e.g. study concepts, protocols and amendments, Investigator Brochures, Clinical Study Reports, clinical sections of CTD submissions etc.

- Responsible for coordinating and aligning activities and communication across multiple studies in the clinical development program

- Responsible for operationalization of approved CDP

- Review & approve the detailed study timelines, budgets, country allocation and resource needs after Study Manager has tested feasibility at country level

- Lead tracking and troubleshooting of operational activities at the program level including co-development projects

- Support the selection of external providers including CROs

- Support management of overall operational program objectives e.g. budget and timelines

- Support Study Manager and all involved functions in accurately tracking and forecasting study resource needs detecting possible problems early, proposing and implementing solutions

- Actively collaborate with GCLs, Study Teams and other key functions (e.g. Global Project Leader, Study Management, Monitoring and Site Management, Statistics etc.) to identify issues/risks and provide timely solutions providing accurate, timely, and accessible information to customers

Qualifications

The desired candidate must have a Bachelor of Science or equivalent with a minimum of 8 years of pharmaceutical industry experience or Master of Science or equivalent with a minimum of 6 years of Pharmaceutical Industry experience. Of this, a minimum of 5 years of Pharmaceutical Clinical Operations experience is desirable including direct monitoring and clinical trial/study management.

Additional requirements:

- In-depth knowledge of the drug development and commercialization process (from protocol writing via study management to medical results reporting and submissions)

- In-depth knowledge of GCP, federal regulations and international regulations (ICH)

- Knowledge in both existing drugs and new fields of exploration in one Disease or

Therapeutic Area

- Proven people management expertise

- Ability to effectively influence without hierarchical authority

- Willingness to embrace change and be able to work in a changing environment

- Strong communication skills to ensure that project plans and status are transparent

- Skills in gathering information for decision-making; negotiation; and communicating

- Able to work both independently and collaboratively across cultures and geographies