ModeX Therapeutics, an OPKO Health company, is the leading clinical-stage biopharmaceutical company developing unique and proprietary multispecific therapeutics. Its MSTAR platform unites the power of multiple biologics in a single molecule to create multispecific antibodies that bind four or more targets with unprecedented versatility and potency for complex diseases. Its promising first-in-class immunology pipeline includes candidates against immune diseases, including cancer (both solid and hematologic tumors), immune impairment, as well as several of the world’s most pressing viral threats. Its founding team includes globally recognized medical innovators with proven track records of delivering breakthroughs for patients. ModeX is based in Weston, Massachusetts. For more information, please visit www.modextx.com. 

The Director will be a key member of project, research and clinical development teams and will play a critical role in driving and executing upon pharmacology and toxicology strategies for our oncology, immune impairment, infectious diseases and cell therapy programs in development.  This includes responsibility for leading IND-enabling studies, execution and reporting on studies, regulatory application oversight and contribution, as well as contributing to early discovery programs.  This position requires a general understanding of key therapeutic areas, excellent communication, collaboration and leadership skills, and an awareness of business principles and cultural values.  The position requires prior experience in nonclinical development specifically toxicology, DMPK, regulatory interactions, health authority applications (eg., INDs, CTAs, BLAs).  This role requires working in a matrixed team environment with Research, CMC, Clinical, Quality, Regulatory, and Program Management functions.

Key Responsibilities:

• Drive the nonclinical development strategy through cross-functional collaboration with internal and external stakeholders in various functional areas.
• Qualify and Manage CROs for toxicology, DMPK, and pharmacology studies, ensuring quality of data and GLPs.
• Review reports and present key findings to project teams and Senior Leadership
• Serve as a strong, adaptable leader with an ability to be on the ground supporting program teams.
• Contribute to regulatory submission strategies for IND-filing and post-IND filing via oversight of pharmacology and toxicology IND compilation teams, provide cross-functional support. 
  • Collaborate closely with other departments such as research and development, clinical development, and regulatory affairs to ensure alignment on program objectives.
  • Participate in the development of scientific publications, presentations, and educational materials related to oncology and infectious disease programs.

Qualifications:

• Advanced degree in biomedical sciences (toxicology, biology, pharmacology or immunology).

America Board of Toxicology certification desired

• 10+ years of experience in biopharmaceutical drug development, operating in the preclinical and translational space and preparing health authority applications.
• Strong interpersonal skills with the ability to motivate others, influence with and without authority.
• Excellent problem solving, critical thinking, and communication skills with the ability to understand, communicate, and present technical and complicated solutions in a clear and simple manner to stakeholders.
• Ability to think strategically, balance short-term and long-term goals, and maintain flexibility to adapt to situations.
• Proven ability to drive high quality studies, manage CROs, processes, and reports supporting regulatory submissions.
• A strong team player with a demonstrated ability to work independently and with partners in research and process development.

ModeX Therapeutics is an Equal Opportunity Employer