Corcept Therapeutics
Director, Translational Science
Corcept Therapeutics, Redwood City, California, United States, 94061
The Director of Translational Science will be accountable for designing and implementing biomarker strategies to deepen our understanding of cortisol modulation for the treatment of oncology and neurology indications. Their work will focus on assets already in clinical development for the treatment of ovarian and other solid tumors, and Amyotrophic Lateral Sclerosis (ALS), informing clinical development plans as well as the mechanism of action and potential companion diagnostics.
Responsibilities:
Nonclinical research
Design and analyze non-clinical experiments to understand the biological role of glucocorticoids in oncologic and neurologic indications
Generate decisional data via contract research vendors and academic collaborators
Partner with Research to discover and characterize novel biomarker endpoints in preclinical studies
Communicate findings with internal project teams, collaborators and public publications
Biomarker research
Develop translational strategies and ensure biomarker-driven decision-making to support clinical development plans, the regulatory path, and product commercialization
Deliver subject matter expertise with respect to clinical biomarkers and other modalities as needed
Develop biomarker methods and analytically validate biomarkers for clinical use
Work with biomarker operations and clinical operations colleagues to ensure implementation of biomarker strategy through review of clinical protocols, contracts, eCRFs, DTAs, ICFs, lab manuals, TLFs, and CSRs
Conduct exploratory biomarker data analyses
Coordinate formal biomarker analyses with biometrics, biostatistics, clinical data management, and external biomarker analysis teams
General
Author patents, publications, and posters related to research activities
Partner with regulatory team to author/lead relevant nonclinical and clinical content for regulatory submissions, including INDs, IBs and NDAs etc
Adhere to agreed timelines and budgets to ensure timely and cost-effective execution of deliverables
Provide disease-biology expertise in cross functional teams and collaborate with other team members
Oversee global CRO vendor/partners ensuring that they optimally execute clinical and preclinical projects
Conduct resource planning and, as needed, hire and lead a team to support the objectives of the translational science group
Preferred Education and Experience:
PhD in Cell or Molecular Biology (or a related discipline) with 10+ years industry experience
Experience in performing and critically analyzing and interpreting both pre-clinical and clinical data using different transcriptomic and proteomic techniques is required
Proven track-record of achievement, as evidenced by publications in peer-reviewed journals, authorship of patents, and internal and/or external scientific presentations
Ability to balance execution of tasks required to accomplish goals while creating an environment of scientific curiosity and open exchange of ideas
Display a consistently positive attitude with team members, scientific curiosity, and the drive to innovate and think creatively with courage, integrity and respect
The pay range that the Company reasonably expects to pay for this headquarters-based position is $215,300 - $253,300; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
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Responsibilities:
Nonclinical research
Design and analyze non-clinical experiments to understand the biological role of glucocorticoids in oncologic and neurologic indications
Generate decisional data via contract research vendors and academic collaborators
Partner with Research to discover and characterize novel biomarker endpoints in preclinical studies
Communicate findings with internal project teams, collaborators and public publications
Biomarker research
Develop translational strategies and ensure biomarker-driven decision-making to support clinical development plans, the regulatory path, and product commercialization
Deliver subject matter expertise with respect to clinical biomarkers and other modalities as needed
Develop biomarker methods and analytically validate biomarkers for clinical use
Work with biomarker operations and clinical operations colleagues to ensure implementation of biomarker strategy through review of clinical protocols, contracts, eCRFs, DTAs, ICFs, lab manuals, TLFs, and CSRs
Conduct exploratory biomarker data analyses
Coordinate formal biomarker analyses with biometrics, biostatistics, clinical data management, and external biomarker analysis teams
General
Author patents, publications, and posters related to research activities
Partner with regulatory team to author/lead relevant nonclinical and clinical content for regulatory submissions, including INDs, IBs and NDAs etc
Adhere to agreed timelines and budgets to ensure timely and cost-effective execution of deliverables
Provide disease-biology expertise in cross functional teams and collaborate with other team members
Oversee global CRO vendor/partners ensuring that they optimally execute clinical and preclinical projects
Conduct resource planning and, as needed, hire and lead a team to support the objectives of the translational science group
Preferred Education and Experience:
PhD in Cell or Molecular Biology (or a related discipline) with 10+ years industry experience
Experience in performing and critically analyzing and interpreting both pre-clinical and clinical data using different transcriptomic and proteomic techniques is required
Proven track-record of achievement, as evidenced by publications in peer-reviewed journals, authorship of patents, and internal and/or external scientific presentations
Ability to balance execution of tasks required to accomplish goals while creating an environment of scientific curiosity and open exchange of ideas
Display a consistently positive attitude with team members, scientific curiosity, and the drive to innovate and think creatively with courage, integrity and respect
The pay range that the Company reasonably expects to pay for this headquarters-based position is $215,300 - $253,300; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
#J-18808-Ljbffr