Lead, Clinical Operations

Job Description

Job Description

Job Title : Lead, Clinical Operations

Job Location : Cambridge, MA, USA

Job Location Type : Remote

Job Contract Type : Full-time

Job Seniority Level : Mid-Senior level

Amylyx was started in 2013 by two Brown University students who had an ambitious goal : to improve the lives of people with neurodegenerative diseases by addressing the root cause.

Today, Amylyx is a pharmaceutical company based in Cambridge, Massachusetts, that is dedicated to the discovery and development of potential treatments for diseases including Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). At Amylyx, we’re bringing together talented people like you who are guided by our values to be Audacious, Curious, Authentic, Engaging and Accountable. Our mission would not be possible without each individual perspective within our team. It's a culture that uses unconventional thinking for unsolved problems.

Rediscover your purpose and reimagine your career at a company whose founders, mission, and culture are unlike any other in life sciences—in all the best ways.

THE OPPORTUNITY

The Lead, Clinical Operations is responsible for managing clinical studies in Post-Bariatric Hypoglycemia (PBH), ALS, PSP, Wolfram Syndrome and / or other diseases under study at Amylyx Pharmaceuticals.

Reporting to the Head Clinical Operations, you will manage day-to-day operations of global trials with little supervision in a small fast-paced company environment. You are a seasoned clinical operations trial manager, comfortable working independently and experienced managing cross-functional activities internally and externally. You enjoy working against the clock and beating timelines, with a keen eye for quality. As an integral senior member of the Amylyx Global Clinical Operations team you possess strong vendor management skills with deep experience managing full-service CROs and leading and / or collaborating with internal cross functional teams. You preferably have experience with managing a Decentralized Clinical Trial setting, working with remote data collection via event-Diary and wearable devices. You are a proactive problem-solver with proficient verbal and written communication skills, comfortable leading study teams working with ambitious timelines.

The Responsibilities

• Directly responsible for the conduct of the trials from start-up through close-out, with close attention to effective planning and execution, risk management, data integrity, quality and compliance with Company SOPs, ICH-GCP guidelines, GDPR, and other regulations and patient safety standards.
• Ensures appropriate operational procedures are implemented or adhered to, to assure high quality trial data and operational excellence of assigned studies.
• Develops, analyses, and reports on metrics for clinical programs.
• In conjunction with Clinical Leadership, ensures study deliverables are achieved on time and within budget.
• Contributes to the development of study documentation including protocol review, study manuals, ICFs, CRFs, Clinical Study Reports etc.
• Communicates trial status, issues, mitigations, and lessons learned to relevant cross-functional stakeholders, including senior leadership.
• Stakeholder in CRO and vendor selection. Works with clinical operations leadership, clinical outsourcing, legal, and finance in the selection and contracting of CROs and vendors. Oversees and contributes to financial reporting for assigned projects including but not limited to PO management, projections, actuals and accruals.
• Manages relationships and establishes strong partnerships with CROs, vendors, investigators, and other external partners.
• Addresses and / or escalates vendor performance issues; identifies probable vendor risks and potential mitigation strategies.
• Develops SOPs, work instructions, and standardized forms to define Clinical Operations processes within a growing team.
• Provides leadership and support to direct report(s), if applicable, including mentoring, training, performance evaluation, and career development.

Required Qualifications

WORK LOCATION AND CONDITIONS

To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn.

To return to our website please click here.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

Lifelancer ( https : / / lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

For more details and to find similar roles, please check out the below Lifelancer link.

https : / / lifelancer.com / jobs / view / e7360fa480377e3f219d003b019f5e06

Apply on Lifelancer Platform