Project Manager

Company Overview

ModeX Therapeutics, an OPKO Health subsidiary, is a clinical-stage biopharmaceutical company developing next-generation multispecific antibodies as novel therapies for cancer and infectious diseases, as well as nanoparticle technologies for the development of next-generation vaccines. ModeX's modular antibody platforms unite the power of multiple biologic components in a single molecule to create multispecific antibodies with greater versatility and potency to fight complex diseases more effectively than traditional approaches. Our current pipeline includes immuno-oncology candidates against both solid and hematological tumors as well as several of the world's most pressing viral threats. Our founding team includes globally recognized medical innovators with proven track records of delivering breakthroughs for patients. Join our team of groundbreaking scientists and leaders today to change the world tomorrow.

External Description

ModeX is seeking a highly skilled and motivated Project Manager to support our infectious disease programs from preclinical stage to early-phase clinical trials. Reporting to the Chief Scientific Officer, this role requires project management expertise, contract management experience, and the ability to coordinate cross-functional teams to achieve project milestones. The successful candidate will be responsible for planning, executing, and monitoring drug development projects to ensure alignment with company goals and regulatory requirements.

Key Responsibilities:

1. Project Planning & Management
   1. Develop project plans, including timelines, milestones, and resource allocation for drug development projects.
   2. Monitor project progress and adjust timelines as necessary to keep projects on track.
   3. Identify potential project risks and develop mitigation strategies to minimize their impact.
   4. Coordinate with contract research organizations (CROs and CDMOs) to manage cost and timelines, ensuring timely and quality delivery of goods and services.
   5. Assist in budget and resource planning, working closely with the finance team to track and manage project budgets.
   6. Collaborate with functional heads to allocate resources, including personnel, equipment, and funding, to support project activities.
2. Scientific Coordination
   1. Support project teams with technical understanding of infectious disease and biologics development.
   2. Stay updated with relevant scientific literature to align project goals with industry advancements.
   3. Work with the regulatory team in preparing documents and data for regulatory submissions.
   4. Ensure project activities adhere to quality assurance standards and regulatory requirements.
3. Cross-Functional Team Leadership
   1. Facilitate communication and collaboration among cross-functional teams, including scientists, clinical, regulatory, and external consultants.
   2. Prepare and deliver project updates and reports to executive teams and key stakeholders.
   3. Escalate challenges and risks as needed, ensuring appropriate support for resolution.

Qualifications:

• 2-5+ years of project management experience in a biotech or pharmaceutical environment, preferably in drug development.
• Knowledge of biopharmaceutical drug development processes, including preclinical research, regulatory requirements, and clinical development.
• Experience contributing to IND submissions is a plus.
• Preferred: MS in a relevant scientific discipline (e.g., biology, pharmacology, immunology, biochemistry, etc.).
• Strong communication and interpersonal skills to facilitate collaboration across teams.
• Proficiency in project management tools and presentation software.
• Experience managing government-sponsored projects is a plus.
• Budget management and resource allocation experience preferred.
• PMP or other project management certification is desirable.

ModeX Therapeutics is an Equal Opportunity Employer