Head of Clinical Operations - ref. e6304903
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:
The Head of Clinical Operations is responsible and accountable for the operational execution of the clinical strategy. This key leader is responsible for planning, oversight and execution of ModeX Therapeutics clinical development programs and studies, planning project/trials, budgeting and financial oversight, working closely with key investigators and thought leaders to lead successful execution of sponsored clinical trials, managing and developing internal staff and consultants/contractors, maintaining collaborative relationship and oversight of CROs, meeting timelines and ensuring GCP compliance.
This includes responsibility for overseeing the implementation and interpretation of clinical trials during the drug development process from Phase 1 on. The position requires that the quality and reliability of the study are ensured and maintained, and that clinical trials meet their objectives, in collaboration with other members of the clinical development team.
Key Responsibilities:
- - Accountable for the overall operational planning, budgeting, and execution of ModeX Therapeutics clinical development programs
- Develop and maintain key investigator and site relationships
- Oversee the development of study project plans, including timelines, metrics, budgets and resources.
- Develop the clinical operations infrastructure
- Lead key strategic clinical operations organizational initiatives by translating the vision into actionable strategies and ensuring that plans are executed per commitments.
- Manage and mentor the clinical operations team to ensure effective development, implementation and execution of clinical trials within agreed timelines, resources and budgets
- Accountable for CRO oversight and vendor relationships
- Develop documents in collaboration with the study teams including but not limited to, informed consent documents, study manuals and regulatory submissions.
- Contribute to documents including protocol synopses, full protocols, investigator brochures, IMPD, DSUR, CSRs and regulatory documents (briefing books, regulatory dossiers).
- Clinical review of data (study related, aggregated) including efficacy and safety data to ensure accuracy and quality
- Provide clinical support for end-to-end management of study queries/sponsor medical monitoring for ongoing clinical trials
- Support activities related to steering committees and advisory boards
Qualifications and Skills
Minimum Education and Experience Requirements- Bachelor’s degree in a scientific field
- 15 years of industry experience with at least 5 years in oncology Ph1 trials, or 10 years of industry experience in oncology including Ph1 trials
- Demonstrated experience in managing clinical operations
- Knowledge and experience with developing, negotiating, and managing contracts (vendor and site)
- Experience in regulatory inspection
- Experience in developing RFPs, selection of CROs/vendors and management external resources
- Demonstrated ability to manage clinical trials within designated program budgets and timelines
- Experience in and understanding of end-to-end management of clinical trial conduct, clinical drug development and clinical trial operations
- Integrity, mature character, self-awareness, credibility and positive can-do attitude. The ability to project calm, resilient leadership; thrives under pressure.
- Proven adaptability to partner with leadership in the advancement of programs in a rapidly evolving environment
- A problem-solver with intellectual curiosity, who seeks to continuously improve, with awareness of external competition and who thinks creatively.
- Energetic, collaborative and proactive. Aa leader who can positively and productively impact initiatives and lead by example with the philosophy that no job is too big or too small.
- Self-starter with high-degree energy, independence, initiative and self-motivation combined with a strong passion for delivering results.
- Ability to foster a culture that is inclusive, focused on working collaboratively in an integrated, independent, highly innovative and energetic environment across internal/external partnerships spanning all phases of development to meet Company strategic objectives
ModeX Therapeutics is an Equal Opportunity Employer