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Senior Manager of Clinical Studies
2 months ago
Salary:
Alumis Inc. is a pioneering company in precision medicine, dedicated to enhancing the lives of individuals affected by autoimmune disorders. Despite advancements in treatment over the past twenty years, numerous patients with immunologic conditions still face significant challenges. Our mission is to revolutionize outcomes for these patients.
We are in search of a seasoned Senior Clinical Trial Manager to become an integral part of our LUMUS study team. The LUMUS initiative is a worldwide, Phase 2 clinical trial focused on assessing the efficacy, safety, and pharmacokinetics of our specialized Tyrosine Kinase 2 (TYK2) inhibitor therapy in adult patients suffering from moderately to severely active, autoantibody-positive Systemic Lupus Erythematosus (SLE). This area is critically underserved, as the only two therapies approved for SLE since the 1950s remain in use, and existing treatments such as oral corticosteroids and broad immunosuppressants are effective for only a limited number of patients.
The Senior Clinical Trial Manager will be essential to our study team, ensuring the effective execution of clinical trials that meet the highest quality standards. Responsibilities include maintaining the integrity of clinical data, adhering to project timelines, and managing budgets for Phase I-IV clinical trials. This role encompasses oversight of vendors, junior personnel, and contractors, with a focus on achieving results within a 1-2 year timeframe.
Key Responsibilities
- Oversee all daily operations of global clinical studies across one or more clinical programs, from initial study synopsis to final project deliverables (study setup, enrollment, conduct, database lock, final TLFs, CSR, etc.).
- Manage the entire lifecycle of clinical trials from initiation to completion, including drafting protocols, informed consent documents, and contributing to clinical sections of Investigator Brochures.
- Conduct site and vendor feasibility assessments, selection, management, and oversight.
- Ensure timely execution and conduct of clinical studies, including tracking budget items, milestones, and timelines, while managing resources effectively.
- Coordinate cross-functional team members (biostatistics, clinical pharmacology, data management, medical monitors) to ensure the initiation and execution of clinical study deliverables within approved budgets and timelines.
- Implement risk management strategies and prioritize competing tasks to ensure successful completion of program/study objectives.
- Provide recommendations for vendor identification, qualification, selection, and oversight, demonstrating a proven track record of successful study execution.
- Contribute to or lead the setup and management of systems including EDC, IWRS, Central Laboratories, and specialty services (ePRO, eDiary, etc.).
- Review and oversee the trial endgame, focusing on data and statistical analyses by critically assessing data to identify trends and outliers.
- Ensure data integrity through routine data reviews, query resolution, and consistency checks for independent data monitoring committees.
- Effectively communicate program/study progress to Portfolio/Program Directors and Senior Management, including creating and updating detailed dashboards and trackers.
- Ensure timely submission of documents to the Trial Master File (TMF).
- Stay informed about the disease/treatment landscape, evolving regulations, and guidance, assessing their impact on clinical projects and making necessary adjustments.
- Approach challenges creatively and resolve problems to optimize clinical trial conduct.
Ideal Candidate Profile
Minimum of 8 years of relevant experience in clinical operations, with a preference for experience in both early and late phases of development. Willingness to travel up to 25% of the time as needed.
Professional Qualifications
- Proven experience in core and technical aspects of initiating and managing Phase 1-4 clinical trials.
- Experience managing sites, CROs, and vendor selection.
- Demonstrated ability to be hands-on and perform tasks within tight deadlines.
- Excellent interpersonal and communication skills, with developing leadership qualities.
- Successful experience in a matrixed environment.
- Familiarity with 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 multitask in a fast-paced environment and build strong cooperative relationships with colleagues.
- Strong attention to detail and ability to author complex documentation with minimal supervision.
- Proactive and accountable, with a high degree of professionalism.
- Previous experience in a pharmaceutical, biotech company, or CRO is preferred.
Preferred Education
B.S. or advanced degree in biological sciences or a related field. Certifications such as Project Management Professional or Clinical Trials Design and Management are advantageous.
Alumis Core Values
- Elevate
- Challenge
- Nurture
This position is based in South San Francisco, CA, with an expectation of in-office presence three days a week. Remote applicants are not being considered at this time.
The salary range for this position is $185,000 to $195,000 annually. This range is an estimate, and actual compensation may vary based on the company's practices.
Alumis Inc. is an equal opportunity employer.
