Senior Medical Director of Clinical Research
Found in: Appcast Linkedin GBL C2 - 3 weeks ago
Senior Medical Director of Clinical Research
Location: Los Angeles/Hybrid
What you will do
In this vital role you will have an opportunity to shape clinical development in multiple Therapeutic Areas.
Responsibilities:
- Serve as clinical expert to provide clinical/scientific knowledge into the development, execution and communication of the global scientific/medical evidence plan for the indication(s).
- Lead medical writing team on drafting of clinical trial protocols for new indications
- Provide oversight of LCM clinical development with input on global strategy
- Support cross-functional and global collaborations to integrate broad medical, regulatory, safety, scientific, and commercial access and value input into the development program(s)
- Participate and provide clinical input into safety and regulatory interactions
- Interpret and communicate clinical trial data
- Author/review CSRs, publications and regulatory submissions
- Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL
- Identify new clinical research opportunities
- Support in-licensing and out-licensing activities and partner relationships
- Support product lifecycle management for new indications
- Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization
- Approximate 10% travel may be required
Knowledge:
- In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale
- In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials in all phases of development, especially Ph1b and 2/3 registrational trials
- Medical knowledge in the relevant therapeutic area
- Sound scientific and clinical judgment
- Understanding of regulatory agency organization, guidelines, and practices and ability to negotiate with these groups
- Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
- Prior experience of regulatory interactions, authoring filing IND or BLA experience
- Understanding of new drug commercialization and business practices
- Understanding of resourcing and budgeting
What we expect of you
- Integrity
- Initiative
- Intelligence
Basic Qualifications:
MD or DO degree from a U.S. accredited medical school
AND
~>2 years of clinical research/drug development experience and/or basic science research
Preferred Qualifications:
- MD plus accredited residency in relevant sub-specialty, board certified or equivalent. (from a U.S. accredited medical school)
- Three (3) or more years of clinical development experience and/or basic science research combined with clinical teaching and patient care activities.
- Clinical development experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
- Experience in development lifecycle management to include development strategy creation for large programs from early development, through late development and commercialization.
- Involved in filing activities as part of the moving the program through the development lifecycle.
- Key relationship development and collaboration with the expansive commercial and medical teams internal and external partners and key opinion leaders.
- Previous management experience of clinical development professionals
What you can expect of us
We strive to build a supportive work environment where every member of our team can unleash and maximize their potential contributing to developing impactful therapies for patients.
In addition to the base salary, Immix offers a benefits package including:
- Medical, dental and vision coverage
- A discretionary annual bonus program
- Stock-based long-term incentives
- Flexible work models, including remote work arrangements, where possible
Immix Biopharma, Inc.
Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease. Our lead cell therapy asset is next generation CAR-T NXC-201 for autoimmune disease, relapsed/refractory AL Amyloidosis, and relapsed/refractory multiple myeloma, currently being evaluated in our ongoing Phase 1b/2a NEXICART-1 (NCT04720313) clinical trial. NXC-201 has the potential to be the world’s first “Single-Day CRS” CAR-T (CRS median onset day 1, median duration 1 day), enabling the potential for a faster return home for patients and supporting ongoing expansion into autoimmune indications. NXC-201 has been awarded Orphan Drug Designation (ODD) by the FDA in both AL Amyloidosis and multiple myeloma. Learn more at www.immixbio.com.
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