Full-Time

Sr. Project Manager

CMC & Clinical Development Operations

Confirmed live in the last 24 hours

Iambic Therapeutics

Iambic Therapeutics

51-200 employees

AI-driven drug discovery for therapeutics

Compensation Overview

$122k - $160k/yr

Senior, Expert

San Diego, CA, USA

In Person

Category
Project Management
Business & Strategy
Requirements
  • Bachelor’s degree in science or engineering field with 7+ years of project management experience in the pharmaceutical or biotechnology industry, or a Master’s degree with 5+ years of relevant experience
  • Strong background in small molecule pharmaceutical development
  • Demonstrated experience in project management within CMC and/or clinical development functions
  • Proven ability to manage timelines, cross-functional coordination, and third-party vendor relationships
  • Familiarity with regulatory submission processes, including coordination of CMC components
  • Excellent organizational, communication, and interpersonal skills with the ability to work across disciplines and levels
  • Proficiency in project management tools (e.g., MS Project, Smartsheet, SharePoint, or similar)
  • Ability to travel up to 10% domestically and internationally
Responsibilities
  • Lead planning, execution, and tracking of project timelines and deliverables across CMC and Clinical Operations to ensure alignment with program milestones and corporate goals
  • Drive day-to-day project management of CMC activities, including drug substance, drug product, analytical development, and regulatory documentation, in close collaboration with internal technical teams and external CDMOs
  • Manage relationships with third-party vendors (e.g., CDMOs, CROs), including oversight of scope, deliverables, timelines, and performance to ensure quality and accountability
  • Develop, integrate, and maintain detailed project plans across development workstreams, including scenario planning, resource forecasting, risk assessments, and budget tracking
  • Serve as the key CMC point of contact for internal cross-functional teams, ensuring timely coordination, clear communication, and proactive risk mitigations
  • Partner with the Clinical Operations team to develop, update, and track clinical study timelines and critical path activities from study start-up through execution
  • Facilitate internal and external team meetings by creating agendas, capturing meeting minutes and decisions, tracking action items, and ensuring timely follow-through
  • Maintain accurate project documentation, including status reports, risk registers, timelines, and meeting records across both CMC and clinical activities
  • Drive coordination and timeline tracking for CMC components of regulatory submissions (e.g., INDs, IMPDs, NDAs, MAAs) in collaboration with the Regulatory CMC team, ensuring timely input from internal teams and CDMOs
  • Monitor progress against project plans and proactively identify risks, delays, or resource gaps; lead or support development and implementation of mitigation strategies
Desired Qualifications
  • Oncology experience preferred
  • PMP certification or formal project management training is a plus

Iambic Therapeutics develops new drugs using an AI-driven discovery platform, focusing on treatments for cancer and neurological diseases. Their technology employs advanced AI models and automated experiments to quickly identify potential drug candidates, which helps reduce the time and data needed to predict how molecules will behave. This streamlined process sets Iambic apart from competitors by allowing for faster drug development. The company not only works on its own drug pipeline but also partners with other pharmaceutical companies to enhance drug discovery efforts. Iambic's goal is to provide effective treatments for complex diseases while generating revenue through its drug development and partnerships.

Company Size

51-200

Company Stage

Series B

Total Funding

$203M

Headquarters

San Diego, California

Founded

2019

Simplify Jobs

Simplify's Take

What believers are saying

  • Recent $50M Series B funding boosts clinical and preclinical program advancement.
  • Partnership with NVIDIA enhances computational resources for AI-driven drug discovery.
  • IAM1363's promising Phase 1 results could lead to breakthrough cancer treatments.

What critics are saying

  • Competition from AI-driven companies like Insilico Medicine and Exscientia is intensifying.
  • Regulatory scrutiny on AI-driven drug discovery processes is increasing.
  • Reliance on strategic partnerships poses risks if partners face financial difficulties.

What makes Iambic Therapeutics unique

  • Iambic uses a proprietary AI-driven platform for drug discovery in oncology and neurology.
  • Their NeuralPLexer technology excels in predicting protein-ligand complex structures.
  • IAM1363, a brain-penetrant HER2 inhibitor, shows high selectivity and efficacy.

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Benefits

Health Insurance

401(k) Company Match

Unlimited Paid Time Off

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

1%

2 year growth

-1%
Entarabi
Jun 20th, 2024
Iambic Therapeutics raises $50M in Series B

Iambic Therapeutics, a US-based biotech company, raised $50 million in an expanded Series B funding round led by Mubadala Capital. The round included Qatar Investment Authority, Exor Ventures, and existing investors like Abingworth, Illumina Ventures, Nexus Venture Partners, Coatue, and Tao Capital Partners. This funding is part of a previous $100 million Series B round closed in October 2023. The funds will be used to advance Iambic's clinical and preclinical programs.

Pharmaceutical Business Review
Jun 19th, 2024
Iambic secures $50m to bolster clinical oncology programme pipeline

Iambic Therapeutics has secured $50m in its Series B extension financing round to bolster its pipeline comprising clinical oncology programmes.

Business Wire
May 23rd, 2024
Iambic Therapeutics Announces Poster Presentation For Iam1363, A Clinical Stage Type Ii Her2 Inhibitor, At The 2024 Asco Annual Meeting

SAN DIEGO--(BUSINESS WIRE)--Iambic Therapeutics, a clinical-stage biotechnology company developing novel therapeutics using its unique AI-driven discovery platform, today announced a poster presentation highlighting the ongoing Phase 1 study of IAM1363, a selective and brain-penetrant inhibitor of HER2 signaling for the treatment of HER2-driven cancers. The TIP (trials in progress) poster will be shared at the American Society for Clinical Oncology (ASCO) Annual Meeting, taking place May 31-June 4 in Chicago. IAM1363 is a small molecule inhibitor of wild-type and oncogenic mutant HER2 proteins, designed to expand the therapeutic index compared to available HER2 inhibitors and to avoid toxicities from off-target inhibition of EGFR. In preclinical studies, IAM1363 has demonstrated over 1000-fold selectivity for HER2 compared to EGFR, a promising pharmacokinetic and safety profile, preferential tumor enrichment, and penetrance of the central nervous system. In HER2 tumor models, including intracranial tumor models, IAM1363 has demonstrated favorable efficacy and tolerability compared to benchmark tyrosine kinase inhibitors and HER2-targeted antibody-drug conjugates. IAM1363 was identified using Iambic’s AI-driven discovery platform and is now being evaluated in a Phase 1 clinical study, IAM1363-01 (NCT06253871)

Business Wire
Mar 28th, 2024
Iambic Therapeutics To Present New Pre-Clinical Data For Iam1363, A Selective And Brain-Penetrant Inhibitor Of Both Her2 Wild-Type And Oncogenic Mutants, At The 2024 Aacr Annual Meeting

SAN DIEGO--(BUSINESS WIRE)--Iambic Therapeutics today announced it will highlight new preclinical data for IAM1363, a selective and brain-penetrant inhibitor of HER2 signaling for the treatment of HER2-driven cancers, in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 5-10 in San Diego. The poster presentation will showcase preclinical data illustrating how the unique binding mechanism and potent HER2 activity of IAM1363 overcomes multiple resistance mechanisms and how its strong EGFR avoidance widens the safety margin. IAM1363 potently inhibits both the wild type and mutant forms of HER2, showing over 1000-fold selectivity against EGFR due to a unique binding mode and tumor enhancement not seen with other HER2 inhibitors, leading to exceptional in vivo efficacy and tolerability in various HER2-driven cancer models, including those resistant to existing HER2-targeting agents. IAM1363 is now in a Phase 1 clinical study. Poster Presentation Details:

Business Wire
Mar 27th, 2024
Iambic Therapeutics Announces First Patient Dosed In Phase 1 Clinical Study Of Iam1363, A Highly Selective Her2 Inhibitor For The Treatment Of Solid Tumors

SAN DIEGO--(BUSINESS WIRE)--Iambic Therapeutics, a biotechnology company developing novel therapeutics using its unique AI-driven discovery platform, today announced that the first patient has been dosed in its Phase 1 clinical study evaluating IAM1363, a selective and brain-penetrant inhibitor of HER2 signaling for the treatment of HER2-driven cancers. “Using Iambic’s AI platform, we have been able to rapidly discover and advance a candidate that is highly selective for inhibiting HER2 compared to effects on EGFR and other tyrosine kinase receptors that contribute to toxicity in patients. Along with its demonstrated CNS penetrance and potential to inhibit both wild-type HER2 and common HER2 mutants, we believe IAM1363 can be a highly differentiated, best-in-class small molecule for the treatment of HER2-altered cancers,” said Iambic’s Chief Medical Officer, Neil Josephson, M.D. The Phase 1/1b trial, NCT06253871, is an open-label, multi-center, dose escalation and dose optimization study, designed to evaluate tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of IAM1363 as monotherapy and in combination with trastuzumab in patients with advanced HER2 cancers