Job Description

Job Description

The Manager/Senior Manager of Clinical Trial Transparency (M/SrM-CTT) is responsible for the strategic planning and oversight of communication of clinical trial information to various stakeholders including study participants, patients, HCPs, and the public. The CTT communication strategy includes the following:

compliance with global disclosure requirements on public websites (e.g. clinicaltrials.gov, EU registry, EMA policy 0070, Health Canada)

sharing data with study participants (treatment assignments, aggregate lay results summaries, individual participant data)

preparing for and tracking public inquiries regarding our clinical research

data sharing with researchers (PhRMA/EFPIA commitments)

supporting patient advocacy communication to ensure trial information is readily available

alignment with journal publications

The M/SrM-CTT will be responsible for the CTT strategic oversight for one or more Development Units (DU), where each DU consists of multiple therapeutic areas for numerous pipeline and post-marketing programs and studies. They will oversee activity that is outsourced to several vendors. They are accountable for compliance, ensuring consistency of public messaging, and implementation of overall effective patient/public communication. On an ongoing basis, they will engage with members of the Clinical Development Team to identify the patient and other stakeholder needs for trial information and recognize how those needs may evolve along the clinical development lifecycle, while ensuring the impact to corporate functions (investor relations, scientific communication, public affairs) is assessed and understood. The M/SrM CTT must establish strong cross-functional relationships within Clinical Operations as well as with Regulatory, Medical Writing, Drug Safety, and Biostatistics to deliver transparent, high quality, timely and effective clinical trial communication. The M/SrM-CTT is responsible for establishing and aligning the CTT plans for each program/study with the overall Patient Engagement (PE) approach. They will present at internal program/study team meetings, as well as external study meetings (such as investigatory meetings).

In addition to the DU/Program Team responsibilities, the M/SrM-CTT will drive continuous process improvement by leading/supporting various projects focused on lean and simple processes, impact analysis for new CTT regulations (such as the EU Clinical Trial Regulation), and may represent Biogen on internal and external working groups. It is important that the M/SrM-CTT stays informed of the evolving CTT and Patient Engagement landscape, including regulatory requirements, numerous trade association commitments, and industry trends.

Qualifications

Education and Qualifications:

Bachelors Degree; Masters degree recommended

Solid understanding of the clinical development life cycle, typically gained through 8+ years of working within the pharma/biotech industry.

Must be knowledgeable of the complexity and variability of CTT requirements and the relationship to Patient Engagement and study/program communication planning. Must be able to articulate the dependencies and demonstrate a strong understanding of these areas and where they intersect.

Must have experience overseeing vendors in an outsourced operating model.

Able to demonstrate success in leveraging technology to optimize process. Expert at mapping processes to identify improvements or address gaps; establishing a lean and simple process. Six sigma or other related credentials would be helpful.

Experience leading global cross-functional projects.

Additional Information

This role is can be remote and located in the US. (Eastern Time Zone working hours),

All your information will be kept confidential according to EEO guidelines.