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CMC Project Management Lead

INTRODUCTION

Attralus is a newly established biotechnology company with novel protein therapeutics directed at systemic amyloidosis, which is responsible for a wide range of disease states that are currently underserved by currently available drugs. To meet our strategy of rapidly advancing our novel products into clinical trials and beyond, the company seeks the services of a project management professional to support the CMC function. Reporting to the Senior Vice President, Head of CMC, the CMC Project Management Lead will work both independently and with cross-functional teams to provide timely, high-quality support of multiple therapeutic projects. The position will function remotely, with occasional travel to the company’s Bay Area home office expected.

ROLES, RESPONSIBILITIES & EXPECTATIONS

  • Develop and facilitate CMC project plans and timelines for development programs from candidate selection through IND and beyond, working independently and with stakeholders across functional areas
  • Establish, document, track and communicate CMC timelines, objectives, deliverables and budgets, including assessment of progress and risks, utilizing program management methodologies
  • Support management of CMC contract service providers, including vendor identification and evaluation, RFP development, proposal evaluation and negotiation, management of Work Orders and Change Orders, invoice review, and management of critical reagents and clinical supply chain, including international shipping as necessary
  • Serve as the primary point of contact for CMC project management both internally and externally
  • Manage potentially competing priorities, budgets, and timelines in a fast-paced, rapid-growth environment
  • Ensure alignment of projects with global strategic plans while identifying risks and constraints associated with CMC activities
  • Lead CMC organizational meetings, providing clear agendas, definitive action items, and documentation of decisions
  • Maintain clear and timely communication with cross-functional project team members and key stakeholders to maintain awareness of project status, issues, contingencies, and milestones
  • Facilitate problem-solving and decision-making independently and as a member of cross-functional teams
  • Responsible for CMC documentation including but not limited to: agendas, meeting minutes, action items, dashboards, risk register, mitigation plan, decision logs, etc.
  • Identify and define risks, mitigations and/or contingency plans. Execute scenario planning and risk assessments, providing options for teams
  • Ensure project progress and upcoming deliverables are understood by the CMC team and provide updates to management.
  • Create and update near and long-term project plans with clearly defined goals. Assure on-time completion of tasks or milestones assigned to support project plans

Requirements / Qualifications

  • A Bachelor’s degree with a minimum of 7 years of experience in the biotechnology and/or pharmaceutical industry, and a minimum of 4 years in CMC project management
  • PMP or equivalent certification is desirable
  • Demonstrated ability to utilize project management and document storage tools is critical
  • In-depth knowledge of biopharmaceutical drug development, especially CGMP, is essential
  • Hands-on technical experience in CMC development of biologic products is desirable
  • Early-stage clinical drug development experience is critical; experience in late stage development and commercial readiness is also desirable.
  • Experience in the authorship or organization of CMC regulatory filings is advantageous
  • Experience working with and managing relationships with CDMOs and CTOs is essential
  • Outstanding organizational, interpersonal, written and oral communication skills are critical, both within and outside of the company
  • Experience working in a fast-paced, startup / small company corporate environment is a significant advantage

Does this sound like you?

Then we'd love to hear from you. Send your resume and cover letter to careers@attralus.com

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Attralus Job

AD/Director, Program Management
Attralus, Inc., (formerly Aurora Bio) is a VC funded privately held development stage biotechnology company focused on improving the lives of systemic amyloidosis patients, through the development of novel diagnostics and therapeutics...
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AD/Director, Program Management

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Overview

Attralus, Inc., (formerly Aurora Bio) is a VC funded privately held development stage biotechnology company focused on improving the lives of systemic amyloidosis patients, through the development of novel diagnostics and therapeutics. We are developing pan-amyloid targeting agents that facilitate diagnosis, and the development of novel immunotherapies designed to clear amyloid fibrils in patients with systemic amyloid diseases. We aim to improve the diagnosis and treatment of systemic amyloid diseases, such as light chain (AL), transthyretin (ATTR), and LECT2 amyloidosis, to increase patient survival and quality of life.

Attralus’ technology has broad applications and the potential to address up to 30 systemic amyloid based diseases.  Attralus has a diagnostic imaging agent currently in a ph 1/2 trial, positioned to potentially be the first approved diagnostic specifically for amyloidosis. The company also has 2 novel therapeutic fusion proteins, directed at amyloid removal, that are in pre-clinical development

Headquartered in South San Francisco and founded in 2019, Attralus has recently completed a Series A funding with VenBio to carry forward its mission to improve the lives of systemic amyloidosis patients

Description

The AD/Director, Program Management will be responsible for providing both strategic and hands-on program and project management expertise. Initially reporting directly to the CEO, the AD/Director will be responsible for creating the program plan and budget and providing daily coordination and tracking of critical activities, assuring all milestones and deliverables are met. The Director will be responsible for developing the program management processes and procedures for the company, determining appropriate software and other tools, structuring regular meetings and communication within the company and with external collaborators.

Responsibilities

Collaborate with the management team to provide project management leadership and execution activities within the company and between external partners and Attralus teams.

Develop and execute integrated cross-functional project plans with established goals, milestones, timelines and budget, with a key focus on bringing pre-clinical therapeutic programs into early clinical development

Conduct and direct day-to-day program activities to meet milestones; monitoring critical path activities to ensure delivery of program objectives.

Drive planning for key drug development milestones.

Maintain effective communication with the management team through oral and written correspondence and ensure adequate documentation of each communication. 

Always use/model/maintain/promote best practices in Program Management, including the use of agendas, minutes, dashboards, maintain document repository, establish and implement templates, tools, and processes to drive efficiency, alignment, communication, and effective planning.

Create and maintain easily accessible, high level program documents in electronic format. 

Recommend, manage and train on necessary software and tools.

Identify, develop and/or maintain an appropriate electronic platform (SharePoint, Shared Folders, etc.) for reporting/archiving/documentation of relevant program information, records, etc. 

Conduct risk management, contingency and scenario planning using appropriate program management tools.

Identify program issues or resource gaps and facilitate resolution.

Communicate program information and support development of program presentations to senior leadership, board members, investors and other key stakeholders as appropriate.

Contribute to budgetary planning at the program level.

Facilitate adherence to Aurora’s governance processes; work with key stakeholders to prepare for those interactions; lead/support as appropriate. Ensure implementation of governance decisions.

Qualifications

Minimum of a BA/BS in a scientific disciplined is required, Advance degree preferred

7+ years of program management or equivalent experience in a pharmaceutical or biotechnology organization.

Experience with research/pre-clinical and early clinical development project planning required. PM Certification is a plus.

Rare disease experience a strong plus (not required).

Desire and ability to work in a start-up, fast paced organization where you will wear many hats.

Must have excellent verbal and written communication skills as well as exceptional organizational capability.

Ability to drive program plans and timelines (across multiple functional areas) is essential.  Proven success in goal setting, prioritization and time management is required.

Understanding of FDA and/or EMA quality and regulatory processes. Prior experience with regulatory filings is desirable. 

Experience working with external partners is desirable.

Ability to work independently in decision-making and resolution of program obstacles and conflicts.

Familiarity with developing budgets and forecasting is desirable.

Ability to function autonomously, with an appreciation of detail while being cognizant of “the big picture.”

Have a patient-first mindset. All decisions made with patients in mind.

Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required.

Benefits/Equal Opportunity Employer

Attralus, Inc. offers both comprehensive benefits and Paid Time Off (PTO) plans for employees, which begin on the first day of employment.

Attralus, Inc. is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.