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Clinical Scientist

Employer
MEI Pharma, Inc.
Location
San Diego, CA
Start date
Oct 4, 2022

View more

Discipline
Clinical, Clinical Research, Science/R&D, Biotechnology
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Biotech Beach
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Job Details

Job Summary:

MEI Pharma is a clinical-stage pharmaceutical company committed to the development and commercialization of novel, best-in-class, cancer therapies intended to improve outcomes for patients. Our approach is to fully understand and leverage the mechanisms and properties of our drug candidates to optimize the balance between efficacy and tolerability to best meet the needs of patients with cancer.

The Director, Clinical Science, participates in the development of the Clinical Development Plans (CDPs) and supports the assigned Sr. Medical Director and SVP of Clinical Development with various deliverables necessary for the assigned asset(s) and/or indication(s). The Director of Clinical Science is expected to perform his/her responsibilities with independence and is likely to have external interactions with key opinion leaders (KOLs), cooperative groups, and external vendors supporting the work of Clinical Science.

Responsibilities & Duties:

Global Clinical Development Planning

  • Gathers information from and collaborates with a variety of external stakeholders, such as clinical investigators, clinicians, scientists, and KOLs, and with multidisciplinary internal groups, for the development of CDPs
  • Supports Medical Directors in developing and/or preparing clinical science information for inclusion into the strategy for the relevant therapeutic/disease area(s), annual and strategic lifecycle plans, and the integrated commercialization plan
  • Maintains scientific and clinical knowledge in the relevant therapeutic and disease area(s)
  • Stays abreast of internal and external developments, trends, and other dynamics relevant to the work of clinical science to maintain a fully current view and perspective of internal/external influences and/or implications for the relevant therapeutic and disease area(s)

Clinical Development Plan Implementation

  • Provides clinical science support for assigned studies and programs
  • Conducts appropriate literature searches
  • Provides input on clinical study design
  • Designs clinical protocols, manuals and forms with guidance and oversight from the Sr. Vice President
  • Collaborates with clinical operation for the successful implementation of clinical trials, including Informed Consent Form (ICF), protocol eligibility checklist, protocol dose modification plans, Case Report Forms (CRFs), CRF instructions
  • Writes and/or reviews additional clinical science documentation and/or clinical science input into other documentation managed by other groups (e.g., protocol summaries, safety monitoring plans, process documents, investigator brochures, etc.)
  • May develop or provide input for clinical presentation slides and other materials for internal/external meetings and/or ongoing communications for review/discussion with Medical Directors (e.g., investigator meetings, pre-study site selection visits, study coordinator or clinical research administrator training, study newsletters, communications to study sites, etc.)
  • Provides additional support with site training, as needed, or requested
  • Support Clinical Development team in clinical review of study data
  • Tracks items for inclusion in protocol/ICF amendments and works with other groups to ensure the timely and appropriate completion of protocol amendments
  • Supports Medical Directors/ Physicians in preparing for internal/external meetings and presentations
  • Participates in the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications, and other materials
  • Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders
  • Coordinates submissions to scientific meetings and/or other appropriate venues or groups
  • If directed, supports Medical Directors, regulatory and other internal partners/stakeholders with completion and submission of regulatory filings and other regulatory documentation
  • Completes and/or leads other special projects, as and when assigned, or otherwise requested
  • Consistently complies with all governing laws, regulations, Company’s Standard Operating Procedures (SOPs) and other guidelines
  • Represents Clinical Development in operational meetings and data management meetings, as  needed

Minimum Requirements

  • Advanced Clinical/Science Degree is preferred (e.g., PhD, PharmD, MD)
  • 5 or more years clinical trial experience with relevant therapeutic area experience
  • Clinical and/or basic science research in oncology, with hematologic malignancies preferred
  • Experience authoring experimental protocols and/or study results and conclusions
  • In-depth understanding of Phase 1 through 3 drug development
  • Strong analytical skills, especially understanding and interpreting scientific research and literature
  • Experience in the principles and techniques of data analysis, interpretation, and clinical relevance
  • Comprehensive understanding of product and safety profiles
  • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint, and Excel)
  • Good business acumen: has working knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc.
  • Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment
  • Good interpersonal, verbal communication and influencing skills; can influence without authority
  • Strong written communication skills
  • Good business presentation skills; is comfortable and effective when presenting to others, internally or externally
  • Good judgment and decision-making skills; knows how to make trade-off decisions while balancing ethics and efficacy
  • Ability to travel 20% of time

ADA Notations:

  • Ability to sit for extended periods of time, handling, feeling with hands, reaching with arms
  • Regular communication (hearing/speaking)
  • Lifting up to 25 lbs.
  • Routine office duties including computer keyboard use
  • Vision requirements include close vision and ability to focus
  • Noise conditions range from quiet to moderate

 

 

Company

MEI Pharma is clinical-stage pharmaceutical company committed to the development and commercialization of novel, best-in-class, cancer therapies intended to improve outcomes for patients. Our approach is to fully understand and leverage the mechanisms and properties of our drug candidates to optimize the balance between efficacy and tolerability to best meet the needs of patients with cancer.

 

MEI Pharma's portfolio of drug candidates includes multiple clinical-stage assets, including zandelisib, currently in ongoing clinical studies intended to support marketing applications with the U.S. Food and Drug Administration and other regulatory authorities globally. Each of MEI Pharma's pipeline candidates has a unique mechanism of action that can target pathways involved in driving various hematological malignancies and/or solid tumors that we believe: (1) have the potential to be best-in-class, (2) address unmet medical needs and (3) deliver improved outcomes to patients either as standalone treatments or in combination with other therapeutic options. MEI is headquartered in San Diego, CA.
 

Stock Symbol:

MEIP

Find Us
Website
Phone
(858) 369-7100
Location
11455 El Camino Real, Suite 250
San Diego
California
92130
United States
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