Job Title
This position is responsible for working alongside the Director of Clinical / Pre-Clinical / TMED / Outcomes Research (OR) R&D Procurement & Supplier Management in developing and implementing a multi-year strategy that expands the capability and flexibility of working with external partners across the R&D organization at Organon. This position is also responsible for directing the activities in support of our current (and future) outsourced scope of work.
Responsibilities will include managing processes and connections between the external partner and the various stakeholders within R&D including Clinical / TMED / OR functional teams and Finance and STS to ensure that we are efficiently and effectively delivering high quality clinical development, translational medicine / early development, and outcomes research activities on time globally.
Tasks include :
- Build and manage the processes and facilitating the network of resources to support the partners' ability to execute on sourced scope of work.
- Manage clinical and pre-clinical operations, and outcomes research sourced activities to support efficient, on-time execution of clinical studies and early clinical study operations.
- Actively facilitate (and escalation as necessary) of process issues related to the delivery of high-quality, on-time materials.
- Collaborate with internal teams and external parties to ensure best possible delivery of sourced submission work through clearly defined objectives and actively managing and tracking overall performance (via metrics) of assigned vendors. This includes providing regular feedback to management on the performance of vendors, ensuring deliverables are met and performance issues are identified, managed, and rectified, and providing regular feedback to vendor management and internal teams on performance issues.
- Actively collaborate with and providing guidance to vendors to assure new capabilities and services are developed and existing capabilities and processes are assessed and improved (on an ongoing basis) and assuring consistent application of roles and processes across projects.
- Support of annual business planning and the analysis and proposal of the annual financial plan related to external partner expenditures.
The incumbent will require a working knowledge of and skills in clinical operations, medical affairs, outcomes research, business operations, outsourcing, and project and change management with a strong track record of demonstrated leadership.
Required Education, Experience and Skills include :
Bachelor's degree or equivalent work experience in pharmaceutical research and development.Knowledgeable of clinical operations and study management, and outcomes research studies for pharmaceutical products, vaccines and / or biologic products.Strong negotiation, interpersonal, communication, and leadership skills.Ability to lead by influence and work effectively in matrix organizational structures.Expert at motivating individuals, teams to manage the change aspects of implementing a new, outsourced model.Must have proven track record to be able to think critically, strategically, independently and problem solve.Must have high level of motivation, drive, and demonstration of Organon leadership values.Excellent written and verbal communication skills including ability to write clearly and concisely.Top notch interpersonal skills in difficult situations.Driver of change and innovation.Ability to work seamlessly with all levels of personnel.Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations.Excellent word processing, SharePoint, Excel, e-mail, and online meeting tool skills.Experience working in a drug development outsourced model, either on the outsourcer or client side with an ability to translate learnings to clinical and outcomes research outsourcing model.Extensive experience with leading successful delivery of projects (pipeline, business improvement, and / or change management projects).At least seven years of working experience with or within a healthcare / consumer care industry project management, clinical operations or outcomes research function that includes working with external partners.