ModeX Therapeutics, Inc.

Compensation

Full Description

The Senior Medical Director will be a key member of program and clinical development teams and will play a pivotal role in driving the collaborative development and execution of clinical strategies for our immune-oncology programs. The Senior Medical Director will play a critical role in clinical study medical monitoring and in collaborative relationship-building with trial investigators and key opinion leaders. The position will also serve as Program Lead for one of the programs in our pipeline, which is rapidly advancing from preclinical stages to initiation of Phase 1 clinical trials. This role requires excellent medical judgement, communication, collaboration and leadership skills, and an awareness of business principles and cultural awareness. Key Responsibilities: • Clinical strategy: Contribute to the development and execution of comprehensive clinical development plans for immune-oncology programs. Provide feedback on clinical study data, reports, protocols, and development plans. Collaborate with early development research teams on clinical aspects and disease indications. • Medical monitoring: Provide medical oversight for ongoing clinical trials, including safety monitoring, data analysis, and interpretation of clinical trial results. Collaborate with study team to prepare and complete clinical study reports, investigator's brochures. • Program Lead role: Partner with the leadership team to guide program from preclinical stages to initiation of Phase 1 clinical trials and beyond. Lead cross-functional teams to deliver seamless integration of activities in research, preclinical, non-clinical, CMC, and clinical as well as external collaborators and contractors. Work closely with the project management team to proactively identify potential risks and develop mitigation strategies to ensure timely achievement of clinical milestones. • Clinical trial design: Contribute to the design and oversight of clinical trials, develop study protocols, case report forms, and informed consent documents, ensuring they are conducted in compliance with regulatory standards and ethical guidelines. • Health authority engagement: Collaborate with the regulatory team to prepare and submit regulatory documents to health authorities, including INDs, NDAs, and BLAs. • Key opinion leader engagement: Build and maintain strong relationships with key opinion leaders and academic institutions to support the company's scientific and clinical objectives. • Cross-functional collaboration & leadership: Collaborate closely with other departments such as research and development, clinical operations, and regulatory affairs to ensure alignment on program objectives. As a program leader, build team cohesion and effectiveness to deliver results. • Publication and Communication: Contribute towards the development of scientific publications, presentations, and educational materials. Qualifications: • Medical degree (MD) with 4 or more years of drug development experience in the biotechnology or pharmaceutical environment • 6-10+ years of experience in hemato-oncology (lymphoma, leukemia, myeloma) is required • Experience in oncology drug development is required; experience in biologics drug development is preferred • Exceptional leadership and interpersonal skills • Knowledge of regulatory requirements and experience interacting with regulatory agencies • Ability to contribute as a subject matter expert, work effectively in and mentor cross-functional teams • Excellent written and verbal communication skills • Strong analytical and problem-solving abilities • A track record of successful clinical trial design and execution ModeX Therapeutics is an Equal Opportunity Employer Requirements: 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. Pay Transparency In order to support the Fair Compensation Strategy by the US Govt., HR Dept., clients are required to adhere to "Pay Transparency Law"; in the impacted states; that have mandated the employers to list the salary ranges in Job advertisements or postings for job opportunities and Job promotions.