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.