Senior Clinical Trial Manager, LUMUS Program

Initial Therapeutics, Inc.; South San Francisco (CA); On-site; USD 185,000 - 195,000; Full time

Job summary

An innovative firm is seeking a Senior Clinical Trial Manager to join their mission of transforming lives through advanced therapies. This pivotal role involves managing global clinical studies, ensuring high-quality execution, and overseeing vendor and team coordination. The ideal candidate will have extensive experience in clinical operations and a strong understanding of regulatory standards. Join a dedicated team that values collaboration and is committed to improving treatment options for autoimmune diseases. This is a unique opportunity to make a significant impact in the field of clinical research while enjoying a supportive work environment.

Benefits

Health insurance premiums paid at 90% for employee, 80% for dependents

Free access to Genentech Bus & Ferry Share program

$100 monthly cell phone stipend

Unlimited PTO for Exempt employees

Free onsite gym

Kitchen stocked with snacks and drinks

Qualifications

• 8+ years in clinical operations with experience in phase 1-4 trials.
• Strong knowledge of US and Global Regulations and Guidance.

Responsibilities

• Manage global clinical studies from start-up to completion.
• Ensure data integrity and adherence to timelines and budgets.

Skills

Clinical Operations

Project Management

Interpersonal Skills

Regulatory Knowledge

Data Analysis

Problem Solving

Education

B.S. in Biological Sciences

Advanced Degree in Related Discipline

Project Management Certification

Clinical Trials Design Certification

Tools

Microsoft Office

Electronic TMF

Electronic Clinical Technologies

Job description

Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.

We are seeking an experienced Senior Clinical Trial Manager to join our LUMUS study team. LUMUS is a global, Phase 2 trial aimed at evaluating the efficacy, safety, and pharmacokinetics of our targeted Tyrosine Kinase 2 (TYK2) inhibitor therapy in adult patients with moderately to severely active, autoantibody-positive Systemic Lupus Erythematosus (SLE). This is a critical area of need, as the only two approved therapies for SLE since the 1950s are still widely used, and current treatments like oral corticosteroids and broad immunosuppressants are only effective for a subset of patients.

The Senior Clinical Trial Manager will play a pivotal role on our study team, ensuring the successful execution of clinical studies to the highest quality standards. You will be responsible for maintaining the integrity of clinical data, adhering to timelines, and managing budgets for phase I-IV clinical trials. This role involves overseeing and managing vendors, junior staff, and contractors, with a focus on delivering results within a 1-2 year horizon.

Join us and be a part of a team dedicated to advancing therapeutic options for SLE patients worldwide.

Responsibilities

Manage all day-to-day operations of:

• Overall operational execution of global clinical studies on one or more clinical programs from initial study synopsis through final project deliverables (study set-up, enrollment, conduct, database lock, final TLFs, CSR, etc.).
• Manage aspects of a clinical trial from start-up through completion, including writing protocols, informed consent documents, and contributing to clinical sections of Investigator Brochures.
• Responsible for site and vendor feasibility, capabilities assessment, selection, management, and oversight.
• Manage the implementation, on-time execution, and conduct of clinical studies, including contributing and tracking the development of budget items, milestones, and timelines, in addition to contributing to the scope and management of resources (including vendor selection). All leading to overall quality, safety, and compliance throughout the duration of the clinical studies and program.
• Coordination of cross-functional study team members (biostats, clinical pharmacology, data management, medical monitors) to ensure initiation and execution of the clinical study deliverables within approved budget and timelines.
• Risk management and mitigation including prioritization of competing tasks and issues to ensure program/study objectives are successfully accomplished on-time.
• Provide recommendations in vendor identification/qualification/selection and oversight with proven track record of successful execution and study completion activities.
• Contribute to or lead the systems set-up/management including EDC, IWRS, Central Laboratories, specialty services (ePRO, eDiary, etc.).
• Understanding of how to review, oversee and deliver the trial endgame, which is the data and statistical analyses by critically assessing data to detect trends and outliers to efficiently direct resources and attention to correct problems early.
• Ensure data integrity through oversight of routine data reviews, query and resolution, consistency checks both internally and for independent data monitoring committees.
• Effectively tracks and communicate (verbally and in writing) program/study progress to Portfolio/Program Directors and Senior Management with ability to create and update detailed dashboards and trackers.
• Responsible for timely submission of documents to TMF.
• Awareness of disease/treatment landscape, changing regulations and guidance with ability to assess the impact on clinical projects and make modifications as necessary.
• Ability to creatively approach challenges and problem resolution to optimize the conduct of clinical trials.

The Ideal Candidate

At least 8 years of relevant experience in clinical operations. Experience in both early and late phase of development preferred. Comfortable with travel and able to travel up to 25% of the time as needed.

Professional Experience

• Demonstrated experience in core and technical aspects of initiating and managing phase 1-4 clinical trials.
• Demonstrated experience in management of sites, CROs and vendor selection.
• Demonstrated willingness to be hands-on and perform tasks within tight turnaround time.
• Possessing excellent interpersonal and communication skills, with developing leadership attributes.
• Success working in a matrixed environment.
• Demonstrated experience in the application of US and Global Regulations and Guidance (SOPs, ICH-GCP, FDA-CFR, ethical standards).
• Experience in data collection, monitoring, cleaning, and analysis throughout clinical development (Phase 1-4).
• Proficiency in Microsoft Office (Word, Excel, Outlook, and Project), electronic TMF, and electronic clinical technologies.
• Able to multi-task in a fast-paced environment.
• Able to build strong cooperative relationships with coworkers.
• Listens, seeks common ground and establishes credibility.
• Author complex documentation with minimal supervision.
• Possess a high degree of attention to detail.
• Proactive and accountable.
• Previous employment at a pharmaceutical, biotech company or CRO preferred.

Preferred Education

B.S. or advanced degree in biological sciences or a related discipline. Certifications such as Project Management Professional or Clinical Trials Design and Management are a plus.

The salary range for this position is $185,000 USD to $195,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.

This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday. At this time we are not considering remote applicants.

Alumis Inc. is an equal opportunity employer.

Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.

Other Benefits

• Health insurance premiums paid at 90% for employee, 80% for dependents
• Free access to Genentech Bus & Ferry Share program
• $100 monthly cell phone stipend
• Unlimited PTO for Exempt employees
• Free onsite gym and a kitchen stocked with yummy snacks and drinks!

We are a hard-working, collaborative team on a mission to transform patient’s lives-- and we aspire to elevate, challenge and nurture one another along the way.