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.

ModeX Therapeutics is seeking a highly-skilled and motivated Senior Project Manager to play a key role in advancing our infectious disease programs from preclinical stage to early phase clinical trials. Reporting to the Chief Scientific Officer, this position requires a solid scientific background, project management expertise, contract management experience, and a track record of successfully leading cross-functional teams to deliver on project milestones. The successful candidate will be responsible for overseeing the planning, execution, and monitoring of drug development projects, ensuring they align with the company's goals and regulatory requirements.

Key Responsibilities:

1. Project planning/management

• Develop comprehensive project plans, including timelines, milestones, and resource allocation for drug development projects.
• Monitor project progress and adjust timelines as necessary to ensure projects are on track for successful completion.
• Identify potential project risks and develop mitigation strategies to address and minimize risks that may impact project timelines or outcomes.
• Negotiate cost and timeline with contract research organizations (CROs and CDMOs). Manage and oversee CRO relationships to ensure timely and quality delivery of goods and services.
• Prepare budget and resource planning for projects. Work closely with the finance team to track and manage project budgets, ensuring efficient resource allocation and cost control. Collaborate with functional heads to allocate resources, including personnel, equipment, and funding, to support project activities.

1. Scientific Expertise

• Utilize a strong scientific background in infectious disease and antibody or vaccine development to understand the technical aspects of drug development and provide guidance to project teams as needed.
• Stay up to date with relevant scientific literature to support project team and program goals.
• Work closely with the regulatory team in preparing documents and data for regulatory submissions. Support interactions with regulatory agencies and contribute to the overall strategy for advancing drug candidates.
• Stay up to date with relevant regulations and industry standards, ensuring that all project activities comply with regulatory requirements and quality standards.
• Ensure that all project activities adhere to quality assurance standards, with a focus on data integrity and compliance.

1. Cross-Functional Team Leadership

• Lead and mentor cross-functional project teams, including scientists, CMC, toxicologists, clinical and regulatory team members and external consultants to ensure effective collaboration and project progression. Foster collaboration and open communication among team members to ensure the success of the projects.
• Prepare and deliver regular progress reports and presentations to executive team and key stakeholders. Escalate to the proper team via the right channel and obtain support to resolve challenges and/or reduce risks.

Qualifications:

• 5-7+ years of project management experience from a biotech or pharmaceutical environment; proven track record of managing projects from preclinical stages to early-stage clinical trials.
• Strong knowledge of biopharmaceutical drug development processes, including preclinical research, regulatory requirements, and clinical development.
• Contributed to successful IND submissions, preferably in infectious disease.
• Preferred: Ph.D. or MS in a relevant scientific discipline (e.g., biology, pharmacology, immunology, biochemistry, etc.).
• Excellent leadership, communication, and interpersonal skills to effectively lead and collaborate with cross-functional teams.
• Expertise in using graphics and presentation tools to illustrate scientific concepts and results.
• Proficiency in project management tools.
• Experience in managing government sponsored projects and familiarity with Earned Value Management is a plus.
• Experience in budget management and resource allocation.
• Regulatory affairs or clinical development experience is a plus.
• PMP or other project management certification is desirable.

ModeX Therapeutics is an Equal Opportunity Employer