Associate Director, Clinical Trial Transparency (C
Company: Biogen
Location: Cambridge
Posted on: June 22, 2022
Job Description:
Job DescriptionCompany Description
Job Description
About This Role The Associate Director (AD), Clinical Trial
Transparency (CTT) Program Lead is integral to the Patient
Engagement, Equity and Transparency team at Biogen and 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 -for
one or more disease Delivery Unit. On an ongoing basis, the AD will
engage with members of the Delivery Unit and Program/Study Teams to
identify the patient and other stakeholder needs for trial
information at all stages along the clinical development lifecycle,
while ensuring the impact to corporate functions (investor
relations, scientific communication, public affairs) is assessed
and understood. What You'll Do
- Work with the Delivery unit, Program and Study leads to
establish the strategy for clinical trial transparency activities
which may include
- compliance with global disclosure requirements on public
websites (clinicaltrials.gov, EU registry, EMA policy 0070, Health
Canada, EU CTR)
- public inquiry management (through collaboration with Medical
Information/Patient Center)
- sharing data with study participants (treatment assignments,
aggregate lay results summaries, individual patient data)
- data sharing with researchers (PhRMA/EFPIA)
- communication with patient advocacy organizations to ensure
trial information is readily available
- alignment with journal publications
- Ensure that the sharing of trial information is consistent the
principles of safeguarding patient privacy; respecting the
integrity of national regulatory systems.
- Process Improvement activities including input into vendor
management optimisation
- Lead and support global projects and may represent Biogen on
external working groups. The AD should stay informed of the
evolving CTT and PE landscape, including regulatory requirements,
numerous trade association commitments, and industry trends. Who
You Are You are a clinical trial transparency subject matter expert
with a passion for patient centricity to help patients connect with
clinical trials and their outcomes in a timely and lay friendly
way. Qualifications
Required Skills
- MUST have 3-5 years experience in the clinical trial
transparency registry within a sponsor organization.
- Bachelors degree with 6+ years OR Associates degree with 8+
years OR HSD with 10+ years of clinical research / project
management experience including clinical site and CRO or sponsor
experience.
- Advanced knowledge of global regulatory environment and
submission processes, global clinical transparency regulations
(e.g., EMA Policy 0070, Health Canada PRCI, EU Clinical Trial
Regulation), and emerging principles/guidelines governing clinical
transparency
- Strong understanding of regulations and guidance's as they
pertain to transparency and disclosure
- Experience in Lay Language Summaries.
- Experience of working with clinical trial transparency vendors
and CRO partners
- Strong project management skills
- Demonstrated ability to work in a cross functional team
- Redaction and anonymization knowledge, including solid
understanding of data privacy regulations
- Innovative critical thinking; detail-oriented yet pragmatic
problem-solving skills
- Strong ability prioritize multiple deadlines and projects
- Excellent written and verbal communications skills Preferred
Skills
- Experience of relating clinical trial transparency to patient
engagement.
- Knowledge of Data Sharing
Additional Information
All your information will be kept confidential according to EEO
guidelines.
Keywords: Biogen, Cambridge , Associate Director, Clinical Trial Transparency (C, Executive , Cambridge, Massachusetts
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