Biogen
Head of Clinical Trial Transparency (CTT) Operations
Biogen, Milwaukee, Wisconsin, United States, 53244
Associate Director Head of Clinical Trial Transparency (CTT) Operations
Join to apply for the
Associate Director Head of Clinical Trial Transparency (CTT) Operations
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Biogen Associate Director Head of Clinical Trial Transparency (CTT) Operations
Join to apply for the
Associate Director Head of Clinical Trial Transparency (CTT) Operations
role at
Biogen About This Role
The Associate Director Head of Clinical Trial Transparency (CTT) Operations leads and oversees all CTT activities, ensuring compliance with global regulations and Biogen policies for clinical trial registration and results disclosure. This role manages CTT resources, driving the function's performance and results. Key goals include aligning public information needs, regulatory requirements, and industry commitments across the portfolio, and maintaining audit and inspection readiness. The Head of CTT Operations also acts as the business unit representative for the CTT vendor, overseeing compliance, contract terms, process improvement, and budget. This position, which contributes to the functional strategy and reports to senior leadership within the CTT structure, is critical for upholding Biogen's commitment to transparency and navigating the evolving regulatory landscape. About This Role
The Associate Director Head of Clinical Trial Transparency (CTT) Operations leads and oversees all CTT activities, ensuring compliance with global regulations and Biogen policies for clinical trial registration and results disclosure. This role manages CTT resources, driving the function's performance and results. Key goals include aligning public information needs, regulatory requirements, and industry commitments across the portfolio, and maintaining audit and inspection readiness. The Head of CTT Operations also acts as the business unit representative for the CTT vendor, overseeing compliance, contract terms, process improvement, and budget. This position, which contributes to the functional strategy and reports to senior leadership within the CTT structure, is critical for upholding Biogen's commitment to transparency and navigating the evolving regulatory landscape.
What You’ll Do
Lead and oversee CTT activities, ensuring global regulatory compliance Manage CTT resources and team performance Ensure alignment of public information, regulatory requirements, and industry commitments Oversee CTT vendor, ensuring compliance and contract terms Provide process oversight of all CTT controlled documents Cultivate relationships with key internal stakeholders Contribute to CTT functional strategy and budget Monitor evolving global regulations and industry trends
Who You Are
This individual is a highly experienced leader in clinical trial transparency, with a strong background in clinical development and operations. They are someone who can strategically navigate complex global regulations while also managing teams and fostering key internal and external relationships.
Required Skills
Bachelor’s Degree required; Master’s degree preferred. Extensive Industry Experience: Over 10 years in pharma/biotech with a solid grasp of the clinical development lifecycle. CTT Expertise: Deep understanding of Clinical Trial Transparency (CTT) requirements, including their connection to Patient Engagement and communication planning. Process Optimization Skills: Proven ability to map and improve processes, ideally with a focus on lean methodologies. Vendor Management: Experienced in overseeing vendors within an outsourced operational framework. Technological Acumen & Project Leadership: Demonstrates success in using technology to optimize processes and has experience leading global cross-functional projects.
Job Level: Management
Additional Information
The base compensation range for this role is: $172,000.00-$237,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
Benefits
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families
physical, financial, emotional,
and
social well-being ; including, but not limited to:
Medical, Dental, Vision, & Life insurances Fitness & Wellness programs including a fitness reimbursement Short- and Long-Term Disability insurance A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) Up to 12 company paid holidays + 3 paid days off for Personal Significance 80 hours of sick time per calendar year Paid Maternity and Parental Leave benefit 401(k) program participation with company matched contributions Employee stock purchase plan Tuition reimbursement of up to $10,000 per calendar year Employee Resource Groups participation
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States. Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
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Join to apply for the
Associate Director Head of Clinical Trial Transparency (CTT) Operations
role at
Biogen Associate Director Head of Clinical Trial Transparency (CTT) Operations
Join to apply for the
Associate Director Head of Clinical Trial Transparency (CTT) Operations
role at
Biogen About This Role
The Associate Director Head of Clinical Trial Transparency (CTT) Operations leads and oversees all CTT activities, ensuring compliance with global regulations and Biogen policies for clinical trial registration and results disclosure. This role manages CTT resources, driving the function's performance and results. Key goals include aligning public information needs, regulatory requirements, and industry commitments across the portfolio, and maintaining audit and inspection readiness. The Head of CTT Operations also acts as the business unit representative for the CTT vendor, overseeing compliance, contract terms, process improvement, and budget. This position, which contributes to the functional strategy and reports to senior leadership within the CTT structure, is critical for upholding Biogen's commitment to transparency and navigating the evolving regulatory landscape. About This Role
The Associate Director Head of Clinical Trial Transparency (CTT) Operations leads and oversees all CTT activities, ensuring compliance with global regulations and Biogen policies for clinical trial registration and results disclosure. This role manages CTT resources, driving the function's performance and results. Key goals include aligning public information needs, regulatory requirements, and industry commitments across the portfolio, and maintaining audit and inspection readiness. The Head of CTT Operations also acts as the business unit representative for the CTT vendor, overseeing compliance, contract terms, process improvement, and budget. This position, which contributes to the functional strategy and reports to senior leadership within the CTT structure, is critical for upholding Biogen's commitment to transparency and navigating the evolving regulatory landscape.
What You’ll Do
Lead and oversee CTT activities, ensuring global regulatory compliance Manage CTT resources and team performance Ensure alignment of public information, regulatory requirements, and industry commitments Oversee CTT vendor, ensuring compliance and contract terms Provide process oversight of all CTT controlled documents Cultivate relationships with key internal stakeholders Contribute to CTT functional strategy and budget Monitor evolving global regulations and industry trends
Who You Are
This individual is a highly experienced leader in clinical trial transparency, with a strong background in clinical development and operations. They are someone who can strategically navigate complex global regulations while also managing teams and fostering key internal and external relationships.
Required Skills
Bachelor’s Degree required; Master’s degree preferred. Extensive Industry Experience: Over 10 years in pharma/biotech with a solid grasp of the clinical development lifecycle. CTT Expertise: Deep understanding of Clinical Trial Transparency (CTT) requirements, including their connection to Patient Engagement and communication planning. Process Optimization Skills: Proven ability to map and improve processes, ideally with a focus on lean methodologies. Vendor Management: Experienced in overseeing vendors within an outsourced operational framework. Technological Acumen & Project Leadership: Demonstrates success in using technology to optimize processes and has experience leading global cross-functional projects.
Job Level: Management
Additional Information
The base compensation range for this role is: $172,000.00-$237,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
Benefits
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families
physical, financial, emotional,
and
social well-being ; including, but not limited to:
Medical, Dental, Vision, & Life insurances Fitness & Wellness programs including a fitness reimbursement Short- and Long-Term Disability insurance A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) Up to 12 company paid holidays + 3 paid days off for Personal Significance 80 hours of sick time per calendar year Paid Maternity and Parental Leave benefit 401(k) program participation with company matched contributions Employee stock purchase plan Tuition reimbursement of up to $10,000 per calendar year Employee Resource Groups participation
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States. Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
Job function Research, Analyst, and Information Technology Referrals increase your chances of interviewing at Biogen by 2x Get notified about new Clinical Trial Associate jobs in
Triangle, NC . Raleigh, NC $55,000.00-$70,000.00 5 days ago Clinical Research Coordinator II, Raleigh, NC
Raleigh, NC $60,000.00-$68,000.00 22 hours ago Clinical Research Associate, Obesity/Diabetes/GLP-1 (Full Service) - IQVIA
Clinical Research Coordinator (Raleigh, NC)
Raleigh, NC $60,000.00-$70,000.00 2 days ago Clinical Research Coordinator - Psychiatry - Behavioral Med - Plassman Lab
Durham, NC $59,829.00-$99,960.00 6 days ago Clinical Research Associate, Sponsor Dedicated
Durham, NC $64,000.00-$189,000.00 1 day ago Clinical Research Coordinator - Psychiatry - Adult Division - Merwin Lab
Durham, NC $59,829.00-$99,960.00 6 days ago Clinical Research Coordinator - Psychiatry - Behavioral Medicine - McClernon lab
Durham, NC $59,829.00-$99,960.00 6 days ago Clinical Research Associate - Sponsor Dedicated
Durham, NC $68,002.00-$108,488.00 4 weeks ago Clinical Research Associate, Sponsor Dedicated
Senior Clinical Research Associate - CNS/Alzheimer's - Southeast - Remote
Senior Clinical Research Associate - Central/West
Senior Clinical Research Associate - Diabetes - West Coast - Remote
Senior Clinical Research Associate - Diabetes - East Coast - Remote
Senior Clinical Research Associate - CNS/Cardio - West
Associate Director/Director, Clinical Trial Manager
Senior Clinical Research Associate - Obesity - Central
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr