Regional Vice President overseeing account management and clinical guidance for national clients at Elevance Health. Collaborating with sales and account management teams to enhance healthcare quality and outcomes.
About the role
- Medical Director leading clinical trials and strategies for innovative cell therapies at Caribou Biosciences. Collaborating with diverse teams to develop transformative therapies for patients with devastating diseases.
Responsibilities
- Leading the direction, planning, execution of clinical trials and interpretation of clinical data
- Establishing scientific methods for design, implementation of clinical protocols, and ensuring trial subject safety
- Leading clinical trials, phases I - IV, for company products under development
- Building and managing the clinical research scientist team supporting clinical trials and overseeing CROs and other vendors
- Building reliable relationship with clinical investigators, discussing trial design, leading investigator’s meetings and advisory boards
- Monitoring safety and reporting adverse events
- Coordinating and developing information for reports submitted to the FDA and other health authorities and representing the Company at different forums
- Monitoring adherence to protocols and determining study completion
- Reviewing clinical data and leading/authoring reports and study related documents, such as IBs, study protocols, publications and regulatory filings including briefing documents, reports, and IND/BLA submissions
- Evaluating products for in/out licensing
- Participating in cross-functional teams, working in a highly matrixed team environment to advance preclinical programs to clinical evaluation
- Staying abreast on the clinical development and regulatory issues related to other competitive or relevant compounds in development and providing recommendations on changes needed to our strategy or clinical development plan as a result
- Provide medical review, assessment and interpretation of clinical data reported in clinical study reports to ensure that the data are correct and presented with the appropriate medical interpretation
- Adhere to both Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) aligned with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)
- Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws
Requirements
- MD degree or equivalent
- Hematology expertise
- Prior experience in cell therapy products
- Experience in clinical trial planning and implementation
- Experience or exposure to FDA/EMA/PMDA/ or other regulatory agencies interactions
- Excellent verbal and written communication skills
- Contributing to the Clinical Strategy and Clinical Development Plans for the Company’s assets
- Proven ability to work independently, as well as to collaborate with peers and work effectively in a fast-paced team-oriented environment
- Strong organizational, time management, communication, and interpersonal skills
- Capable of managing multiple diverse projects simultaneously
Benefits
- Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
- Generous paid vacation time, in addition to company-observed holidays
- Excellent medical, dental, and vision insurance
- 401(k) retirement savings plan, which includes matching employer contributions
- Employee stock purchase plan (ESPP)
- Tuition reimbursement program
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
Clinical Director leading early clinical development strategy in Immunology for novel therapeutics. Collaborating across teams and executing studies to validate clinical platforms and targets.
Medical Director ensuring clinical determinations and enhancing care quality at MVP Health Care. Collaborating with teams to improve health care delivery in New York.
Executive Medical Director leading clinical development strategy for nephrology programs at Travere Therapeutics. Responsible for cross - functional leadership and regulatory interactions in rare diseases.
Medical Director responsible for clinical consultation, policy development, and quality improvement initiatives for CareSource. Must have an MD or DO and live in Massachusetts.
Medical Director overseeing administration of health services at Elevance Health. Requires extensive clinical experience and responsibilities in program management and quality improvement.
Medical Director for Elevance Health to manage healthcare services and improve clinical outcomes. Responsible for administration, strategy, and operational guidance in the healthcare sector.
Senior Clinical Development Medical Director overseeing scientific strategies for clinical trials at Novartis. Collaborating with global teams to ensure safety and oversee project deliverables.
Associate Medical Director responsible for medical content that elevates HCP education at Real Chemistry. Collaborating with cross - functional teams to drive impactful deliverables across multiple therapy areas.
Clinical Director leading a Family Health Organization in Toronto, Ontario. Guiding clinical protocols and mentoring physicians in a hybrid medical model.