Senior Medical Director
To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration of life and resolve serious medical healthcare needs. We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission.
Summit Activities
We have in-licensed Ivonescimab, which is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. We plan to initiate phase-III clinical studies in the following NSCLC indications:
Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) (“HARMONi”)
Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (“HARMONi-3”)
Ivonescimab is an investigational therapy that is not approved by any regulatory authority. It is currently being investigated in Phase III clinical studies.
Overview of Role:
We are seeking a physician-scientist to serve as Medical Directors (Senior Director/Director level commensurate with experience) within Clinical Development Group. The incumbent will be primarily responsible for developing and executing an integrated clinical trial program including protocol design and medical oversight of new or ongoing studies. He/she will be responsible for obtaining scientific advisory input, work with biostatisticians for phase 2 and 3 design and analyses, support regulatory interactions for product advancement, and work closely with operations to provide advice and decision making regarding medical input to achieve operational excellence. The candidate must have demonstrated effective collaborative skills to work across various phases of clinical development and serve as a key medical expert for multiple cross functions teams. Medical insight across a myriad of functions from discovery to manufacturing are expected. Investigator engagement including travel to support face to face interaction and protocol training is a vital component of this role. Prior experience in a mid-sized, fast-growing pharmaceutical environment is preferred, as this role will be working on product development in an extremely fast paced and intense environment. The Medical Director will serve as a leader on one or more potentially pivotal programs reporting directly into the Head of Clinical Development.
Role and Responsibilities:
- Making vital contributions, and leading 1-2 pivotal programs in clinical development program
- Directing human clinical trials, phases 1-3, for lead candidate in development, helping to ensure all clinical development milestones are met including enrollment goals.
- Participating in medical review of adverse event reports and monitoring of incoming safety data in conjunction with product safety/pharmacovigilance, including evaluating and escalating safety signals
- Coordinate and develop information for reports submitted to FDA, EMA, PMDA, and government, regulatory, or partner agencies
- Presentations to various external stakeholders - regulators, governing and harmonization bodies, principle investigators, scientific conference attendees, advisors and opinion leaders
- Knowledge of clinical trial conduct to support operational needs for planning and executing clinical trials, including adherence to protocols, safety reviews, assay development, training, and clinical document review
- Planning, reviewing and editing Clinical Study Reports
- Planning, reviewing and editing publications from the program
- Providing input on the design of clinical studies supporting clinical strategy
- Other duties as assigned
Experience, Education and Specialized Knowledge and Skills:
- Board certified or eligible MD with hematology/oncology product development and experience across stages of clinical development
- 3 to 5+ years’ experience in pharmaceutical, biologics, or biotech R&D environment, or in a research environment involving the collection and analysis of human data in the area of hematology/oncology
- Working knowledge of clinical development pathways for hematology/oncology therapeutics in the US and EMA
- Self-starter who will move forward with key initiatives without being prompted, able to perform a myriad of tasks needed to support the clinical development program, possesses a highly entrepreneurial and growth mindset, works collaboratively with cross-functional teams, loves a good mission.
- Clear and provable evidence of effective leadership skills.