Head of Biomarker Discovery & Development
Our client is a pharmaceutical company. They have asked us to assist them in a search for a Head of Biomarker Discovery & Development.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Leads the Biomarker Discovery and Profiling group in the implementation, of diagnostic, pharmacodynamic, and predictive biomarkers, across the clinical portfolio. Develops organization-wide strategies to provide desired biomarker support to the Company and its portfolio assets.
- Oversees and direct the Biomarker Discovery and Development group to design biomarker development strategies for portfolio agents in conjunction with and in support of the Program Lead for novel agents in a variety of therapeutic areas and disease states.
- In collaboration with the Program Lead, Clinical Operations Lead, and other scientists, contributes to the definition of biomarker deliverables and associated resource needs within each clinical program.
- Articulates biomarker strategy to senior leadership and key stakeholders.
- Manages external alliances and partnerships to develop and execute a biomarker strategy. As necessary, initiates new work with CROs by interfacing with strategic sourcing group and ensure qualification of new CRO labs by working with Quality leads.
- Reviews and evaluates translational research results from clinical trials to inform development strategy, operational tactics, and future marketability.
- Contributes to the preparation of submission documents for INDs and CTAs to regulatory agencies.
- Acts as a liaison between the company and external translational scientists and consultants/vendors.
- Ensures that all biomarker activities involving clinical trials are compliant with GCP and company SOPs.
- Collaborates closely with Business Development colleagues in providing scientific/medical assessment and strategic input on potential pre-clinical and clinical in-license opportunities.
- A PhD is required.
- Must have at least 15 years of pharmaceutical industry experience, preferably within both large pharma and biotech environments. At least 12 years must be in a role having direct responsibilities for biomarker development and application.
- Requires a demonstrated knowledge of and history of successful application of biomarkers to the clinical development of novel agents, preferably within, but not limited to the Oncology, Auto-immunity, or Cardiometabolic Disease therapeutic areas.
- Must possess self-motivation, creativity, and a willingness to take a “roll-up the sleeves” approach to the formulation and execution of biomarker R&D plans.
- A thorough knowledge of translational medicine and molecular diagnostics concepts, practices, and GCP & ICH guidelines is required.
- Must have experience working with internal and outsourced matrix-structured clinical development teams.
- Prior experience with line management of R&D staff is preferred, though not required.
- Must have an analytical mind-set with excellent technical and problem-solving skills.
- Proven experience in contributing to the overall strategic direction of an R&D organization is required.
- Must have outstanding written and verbal communication and leadership skills.
- The demonstrated ability to interact effectively with external clinical investigators and scientists, key opinion leaders, and senior management is required.
- Requires the ability to work collaboratively and excel in a fast-paced, dynamic, and high-growth science-focused R&D environment.
- Strong organizational and interpersonal skills are required.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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