Sr. Director, Clinical Science

Meet Recruitment
San Carlos United States
Permanent
Full-time

Sr. Director, Clinical Science

144392 Posted : 14th May 2024

  • 250000 USD - 300000 USD
  • San Carlos, United States
  • Permanent

Sr. Director, Clinical Science

Remote Based

Oncology-Hematology Cell Therapy

Pay Range : $280,000 - $300,000

Overview :

Meet are exclusively partnering with a mid-sized biotech who have developed a T-cell based immunotherapy platform targeting both solid and liquid tumors.

Off the back of their first FDA approval they are anticipating significant growth of 30% across multiple business sectors in H2 of this year.

The Senior Director, Clinical Science participates in development of the Clinical Development plans (CDPs) and supports the assigned Medical Director / Clinical Science Physician(s) with various deliverables necessary for effective and efficient CDP and clinical trial execution for the assigned assets / indication(s).

The Senior Director, Clinical Science has primary responsibilities for supporting Medical Directors / Clinical Science Physicians with clinical documentation, representing Clinical Science on various teams / sub-teams or other appropriate forums, supporting training and interactions with study site personnel.

The Senior Director, Clinical Science is expected to perform their responsibilities with more independence and are likely to have external interactions with cooperative groups, key opinion leaders (KOLs), and external vendors supporting the work of Clinical Science.

Responsibilities :

  • Maintains scientific and clinical knowledge in the relevant therapeutic and disease area
  • Collaborates with a variety of internal and external partners and stakeholders
  • Supports CS Medical Directors / Clinical Science Physicians, as assigned, in developing and / or preparing clinical science information for inclusion into the CS strategy for the relevant therapeutic / disease area
  • Contributes to the development of the Clinical Study Protocol for relevant assets
  • Provides clinical science support for assigned studies and programs
  • Designs and contributes to writing of clinical protocols, manuals and forms with guidance and oversight from CS Medical Directors / Clinical Science Physicians
  • Represents Clinical Science (CS) in operational meetings
  • Participates in the relevant cross functional team meetings
  • Support Clinical Science team in clinical review of study data

Education and Background :

  • PhD or PharmD
  • 10+ years experience in clinical development / clinical science within oncology / hematology / cell therapy
  • Experience with authoring clinical study protocols and summarizing study results and conclusions
  • In-depth understanding of Phase 1 through 4 drug development

To learn more about the position please contact Division Director Share this

Apply for this role

30+ days ago
Related jobs
Promoted
Gilead Sciences, Inc.
Foster City, California

Director, Biologics Drug Product MSAT. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. Senior Director, Biologics Drug Product MSAT. Participate in writing, reviewing and approving CMC sections of US a...

Gilead Sciences
Foster City, California

You will typically lead multiple components of clinical trial programs in IBD/inflammation clinical development. Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines. Provides input into, or otherwise leads...

Vaxart
South San Francisco, California

Demonstrated understanding of regulations and guidelines governing clinical trial operations, including good clinical practice, clinical trial design and execution, the patient journey, clinical pharmacology, biostatistics, and clinical operations. Director, Clinical Operations w...

Gilead Sciences
Foster City, California

This may include, but is not limited to, providing statistical consultation on clinical development plans, clinical trial design and clinical study endpoints, calculating sample size, authoring statistical analysis plans, and providing biostatistical input into clinical development documentation, sc...

Gilead Sciences, Inc.
Foster City, California

The Senior Director, Enterprise Data Science Council Program Lead will work closely with the senior data science leaders, in particular the current Council Chair, Senior Vice President of Clinical Data Sciences. Director, Enterprise Data Science Council Program Lead. The purpose of this council is t...

Katalyst HealthCares & Life Sciences
South San Francisco, California

Oversee data management activities for multiple clinical studies. Collaborate with clinical study teams to develop and review study protocols. Serve as a key member of clinical study teams, providing data management expertise and support. Collaborate with cross-functional teams, including Biostatist...

Gilead Sciences, Inc.
Foster City, California

We aim to be a trusted source of unbiased, personalized, evidence-based clinical decision support for Gilead’s medicines provided through seamless multi-channel experiences to improve patient outcome. As an equal opportunity employer, Gilead Sciences Inc. ...

Bristol Myers Squibb
Brisbane, California

The Clinical Science Lead reports through the Clinical Science function which provides scientific expertise necessary to design and deliver clinical studies and programs. Leads the Clinical Science team in the planning and execution of clinical trial activities to support the Clinical Development Pl...

Gilead Sciences, Inc.
Foster City, California

The Real-World Evidence (RWE) function at Gilead is part of the Clinical Data Sciences (CDS) group within the Clinical Development organization and aims to unlock the power of Real-World Data (RWD) to help transform innovations to life-changing medicines for patients. The Senior Director, RWE Inflam...

Gilead Sciences, Inc.
Foster City, California

This may include, but is not limited to, providing statistical consultation on clinical development plans, clinical trial design and clinical study endpoints, calculating sample size, authoring statistical analysis plans, and providing biostatistical input into clinical development documentation, sc...