VP Translational Medicine - Remote Position

Primary Objective of Position

The Vice President, Translation Medicine, is a fully independent Clinical Scientist whose primary focus is to oversee the development and integration of preclinical, translational, biomarker and companion diagnostic strategies and studies related to the company's development of alisertib and other investigational agents. This individual will provide leadership and strategic coordination of internal and external translational scientists. This individual interacts closely with members of the clinical development team as well as well as regulatory authorities and key opinion leaders, providing support to the projects and is accountable for generation and execution of all Translation Medicine & Diagnostic input and deliverables. Responsibilities may include some or all of the following:

Major Duties/Responsibilities

• Provide the vision and leadership for the Translational Medicine & Diagnostics department in developing and integrating key translational, biomarker and diagnostic development to support Puma's Clinical Research and Development pipeline

• Develop companion diagnostic (CDx) plans that support patient selection strategies for ongoing and planned clinical trials

• Manage external vendor to ensure a seamless integration of CDx development and validation with the clinical program

• Manage external vendors in developing key regulatory documents to support the use and eventual approval of a CDx

• Manage vendor to ensure patient access of commercial products through biomarker identification

• Develop strategies that support inclusion of biomarker identified patient populations in key pathways and clinical guidelines

• Define and oversee all non-clinical and translational studies performed at contract research organizations and through academic collaborations

• Act as Puma's technical lead on publications and posters related to biomarkers and non-clinical activities

• Review, interpret, and present clinical and non-clinical data from development programs and the relevant literature at relevant governance and regulatory meetings, scientific congresses and advisory committees

• Interface with multi-function departments including Clinical Science, Medical Affairs, Clinical Operations, Biostatistics and Regulatory to identify and analyze potential pharmacodynamic and predictive biomarkers related to non-clinical and clinical activity of Puma's pipeline products

Primary Objective of Position

• Author and review relevant Clinical Study Reports, clinical and non-clinical components of modules for the NDA, MAA and other regulatory submissions

• Represent supported projects at scientific conferences and advisory committees

• Leads interactions on biomarkers with investigators and cooperative groups

• Provide Project Team leadership to on clinical trials and projects as assigned

• Other duties as assigned

Skills & Abilities

• Experienced in strategic approaches to development of biomarkers, novel assay development and genomic/protein-based data interpretation

• Recent experience with the development and validation of NGS- or proteomic based Companion Diagnostic assay and track record of gaining market approval for CDx

• Experienced with established and state-of-the art pre-clinical (in vitro and in vivo) testing methods, models and platforms for testing the therapeutic activity of targeted anti-cancer therapeutics

• Must have deep knowledge of cancer biology and current anti-cancer targeted therapeutic strategies

• Must be fully knowledgeable and skilled in the development and implementation of a clinical plan, protocol design/writing, study team management, data review/interpretation and clinical study reports

• Oversee the clinical management of 1 -3 drug products and programs

• Must be skilled in functional and cross-functional people and project management

• Must be fully knowledgeable and skilled in the development and writing of regulatory documents including INDs, NDA/sNDAs and IBs

Education & Professional Experience

Required:

• Advanced Clinical/Science Degree (e.g. PharmD, PhD, MSN, MPH)

• Minimum of 10 years pre-clinical, translational and clinical development experience in the pharmaceutical or biotechnology industry

• Knowledge of international regulations pertinent to current clinical development (eg ICH, FDA, EMA)

Other Requirements

• Highly advanced oral, writing and presentations skills

• Communicates internally with senior management

• Communicates externally with scientific congresses and advisory boards

• Management of Staff

• Up to 5-10 direct reports including an administrative team member

• Oversees the clinical team working on a given program(s).

Physical Demands

The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.

The physical demands of the office are normally associated with extended amounts of time in front of a computer. While performing the duties of this job, the employee is frequently required to stand, walk, and sit. Travel as needed (up to 10% expected, including international travel).

Compensation Range

The base compensation range for this position is $275k - $325k per year, higher compensation may be available for someone with advanced skills and/or experience.