Immpact Bio West Hills , CA 91307
Posted 2 months ago
ImmPACT Bio USA, Inc., is a clinical-stage company dedicated to the discovery of transformative chimeric antigen receptor (CAR) T-cell therapies that address key biological challenges in treating cancer and autoimmune diseases. The company's logic-gate-based CAR T-cell platforms, licensed from University of California, Los Angeles (UCLA) Technology Development Group, are specifically designed to deplete B cells, prevent antigen escape, and overcome the immunosuppressive tumor microenvironment. The company's technology is based on the work of pioneering scientists Yvonne Chen, Ph.D., and Antoni Ribas, M.D., Ph.D., both from UCLA.
ImmPACT Bio is looking for an exceptional individual to join our growing team as Senior Medical Director. This position will report directly to the Chief Medical Officer and be responsible for participation in all aspects of clinical development, working collaboratively with the Clinical Study Team and contributing to the strategic planning and execution of clinical plans in autoimmune neurological disorders.
Primary Responsibilities:
Provide subject matter expertise to inform the clinical development plan for each asset tested in autoimmune neurological disorders
Organize and lead clinical development advisory boards and safety monitoring boards
Author clinical documents to support regulatory submissions from IND through BLA/MA
Represent Clinical Development in the selection and monitoring of CRO and external laboratory activities
Work with Data Management in the design of electronic case report forms
Work with Translational Medicine and Clinical Operations to design a feasible and cost-effective sample acquisition and biomarker testing schedule
Collaborate with Clinical Operations to engage, recruit, and activate academic and non-academic sites for clinical trial participation
Serve as the point-of-contact for clinical sites on matters of protocol-specified eligibility, treatment, monitoring, and assessments
Aid Clinical Logistics, Technical Operations, and Quality in the scheduling of patient leukapheresis and product release
Organize and lead routine investigator calls
Review and analyze clinical data from company-sponsored clinical studies
Ensure that the reported data is accurate, complete, and verifiable
Review listings for coded terms consistent with the Medical Dictionary for Regulatory Activities (MedDRA) and WHODrug
Ensure that the trial is conducted in compliance with the currently approved protocol
Address safety issues across studies and assist in Pharmacovigilance activities
Collaborate with Project Management, Clinical Operations, and all departments in the preparation of annual IND reports, clinical study reports, manuscripts, and scientific presentations
Identify study and program risks, and create and implement mitigation strategies with Clinical Operations
Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines
Review and sign off on clinical documents with respect to medical relevance
Summarize, interpret, and distribute findings from abstracts and publications relevant to the clinical development of company assets
Collaborate with Medical Affairs to deliver accurate, succinct, and timely communication of clinical and scientific presentations to healthcare professionals, proactively and in response to requests for information, in accordance with regulatory requirements and promotional compliance
Assist Corporate Development in diligence activities and competitive intelligence
Basic Qualifications:
American Board of Psychiatry or Neurology eligible or certified
Minimum 10 years clinical research experience with at least 5 years in the Biotechnology or Pharmaceutical industry
Familiar with early and late phase clinical trial design
Knowledgeable of FDA guidance regarding clinical research trials
Able to interact with and train clinical monitors and physician investigators, and build constructive, trusting, and respectful relationships with colleagues at all levels within and outside the organization
Must possess excellent leadership, communication, and organizational skills and be able to exercise sound critical thinking and problem-solving skills and execute position responsibilities with minimal guidance
Experienced with FDA interactions leading to drug approval strongly preferred
Location:
Travel Requirements:
Up to 20% travel
Willingness to travel domestically and internationally for business meetings and scientific conferences. Travel as required to meet with the clinical site team, CRO, ImmPACT Bio team, and company leadership in West Hills, CA company headquarters
At ImmPACT Bio we embrace transparency in our total rewards pay and benefits program and philosophy. We believe in offering and maintaining competitive compensation and benefits programs for our employees to attract and retain a talented, highly engaged workforce. Our compensation programs are focused on fair and equitable pay practices including market based and data supported base pay, an annual performance-based bonus plan, and equity grants (ISO) for new employees.
Compensation for the role will depend on several factors, including a candidate's qualifications, skills, competencies, and experience.
Salary Range
$310,000-$375,000 USD
ImmPACT Bio provides a generous Total Rewards package, to include a competitive base salary, bonus, and equity package as well as generous benefits and paid time off programs. ImmPACT Bio is an Equal Opportunity Employer and will review all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. All information will be kept confidential according to EEO guidelines.
Immpact Bio