Executive Director, Clinical Biomarkers

Our client is a clinical phase biopharmaceutical company, focused on developing novel antibody drug conjugates and radio ligand therapies to cure cancer. The Head of Clinical Biomarkers and Diagnostics will develop and implement comprehensive plans to support optimal patient selection for candidate drugs in all stages of development from establishing early screening assays to submission of NDA/BLAs. In this role, they will lead the design, development, and implementation of in vitro diagnostics for multiple oncology programs, enabling the realization of personalized medicines. This role reports to the SVP Translational Sciences.

ESSENTIAL DUTIES & RESPONSIBILITIES:Proactively develops plans to provide stage specific data for all assets from late-stage research through regulatory submission for drug approval. Executes on the plans to provide high quality data to support internal decision making and regulatory submissions.Actively partners with other functions and departments to ensure that programs are progressed seamlessly through the development process.Identifies external collaborators such as contract research organizations, academic collaborators, and key opinion leaders. Manages and oversees these relationships to ensure cost, timelines, and quality requirements are met or exceeded. Interpret and present data to relevant senior management and governance committees to enable high quality decision making.Contributes to clinical trial design such as providing dose and dose interval selection, proof of mechanism assessment, and potential drug-drug interactions.Author relevant sections of clinical protocols and regulatory submissions (such as IBs, CTDs, INDs, BLAs).Participates in assessment of in license assets to provide a recommendation to senior management.Represents the function at internal and external meetings, providing clear assessment of data to communicate the potential and value of pipeline assets.Actively participates in functional senior leadership meetings.Plans for headcount needs, recruiting and retaining high quality scientists to enable rapid progression of compounds through the development cycle.

Requirements:KNOWLEDGE, SKILLS, AND ABILITIES:Excellent skills in assessment of the appropriate in vitro diagnostics to support clinical development at all stages of product development. Demonstrated experience supporting clinical and regulatory development of in vitro diagnostics, with excellent working knowledge of the regulatory process. Engagement in cutting edge technologies which improve decision making and align with regulatory partners.Excellent problem-solving skills and ability and desire to oversee multiple projects simultaneously in a fast-paced environment.Demonstrated experience in leading cross-functional teams in the development and execution of biomarker and diagnostics plans to support preclinical and clinical development.Outstanding interpersonal and communication skills (written and oral) with ability to communicate complex information succinctly.Experience authoring relevant sections of global regulatory submissions and interacting with global health authorities.Experience with developing, leading, and executing translational strategies, such as the transition from discovery research into clinical development.Ability to drive collaboration, achieve results, influence, and resolve conflicts across internal and external project teams.

EDUCATION AND EXPERIENCE:Ph.D. in a relevant scientific discipline (DMPK, clinical pharmacology, pharmacometrics, immunology)10+ years' experience in pharmaceutical/biotechnology industry, preferably with large molecule experience.Experience in successful submission of at least one global filing for approval (NDA/BLA).Experience of development of anti-cancer agents, preferably ADCs and/or RLTs.