Associate Director, Program and Project Management

Company Overview

This is an exciting time to join our cutting-edge organization! ModeX Therapeutics, an OPKO Health company, is developing the next generation of multi-specific antibodies as novel therapies for cancer and infectious diseases, as well as nanoparticle technologies for the development of next generation vaccines. Join our team of groundbreaking scientists today and change the world tomorrow.​​​​​​​

External Description

The incumbent will play a key role in advancing our infectious disease and oncology programs from preclinical stage to early phase clinical trials. This position requires a solid scientific background, project management expertise, 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:

Project Planning

• 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.
• Negotiate cost and timeline with contract research organizations (CROs). Manage and oversee CRO relationships to ensure timely and quality delivery of goods and services.
• Identify potential project risks and develop mitigation strategies to address and minimize risks that may impact project timelines or outcomes.
• 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.

Scientific Expertise

• Utilize a strong scientific background in infectious disease and/or oncology fields, and antibody and vaccine development to understand the technical aspects of drug development and provide guidance to project teams as needed.
• 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.

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:

• Ph.D. or MS in a relevant scientific discipline (e.g., biology, pharmacology, immunology, biochemistry, etc.).
• Minimum 7 years or 10 years of experience postgraduate for Ph.D. or MS, either in a scientific role or in project management. The project management experience is from a biotech or pharmaceutical environment with a 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. Having had successful IND submissions, preferably in infectious disease and/or oncology fields.
• Excellent leadership, communication, and interpersonal skills to effectively lead and collaborate with cross-functional teams.
• Proficiency in project management tools and software.
• Having experience in budget management and resource allocation.
• Regulatory affairs or clinical development experience is a plus.
• PMP or other project management certification is desirable.

About ModeX TherapeuticsModeX is a clinical-stage biopharmaceutical company developing next-generation antibodies and vaccines for cancer and infectious disease. 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 disease than traditional approaches. Our pipeline includes candidates against both solid and liquid 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. ModeX is an OPKO Health Company based in Natick, Massachusetts. For more information see modextx.com.