Head of Translational Medicine - Clinical
Hiring Manager: VP, Nonclinical and Diligence
Date Opened: June 2019
The Head of Translational Medicine will be responsible for the design, execution and completion of externalized Translational studies required to advance programs across the portfolio.
Roles & Responsibilities:
Leads translational medicine implementation, which includes but is not limited to diagnostic, pharmacodynamic, and predictive biomarkers, across the Boston Pharmaceuticals clinical portfolio. Develops organization-wide strategies to provide desired translational research and biomarkers support to the Company and its portfolio agents through Phase 2 proof-of-concept.
Designs translational research and development (R&D) 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 Boston Pharmaceutical’s scientists, contributes to the definition of translational research deliverables and associated resource needs within each clinical program.
Identifies and selects external vendors and academic laboratories to support translational research activities conducted as part of clinical trials
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 Boston Pharmaceuticals and external translational scientists and consultants/vendors.
Ensures that all translational medicine activities involving clinical trials are compliant with GCP’s and company SOPs.
Represents Boston Pharmaceuticals at key international and national medical and scientific meetings including participation in advisory boards with key option leaders
Collaborates closely with Business Development colleagues in providing scientific/medical assessment and strategic input strategic on potential pre-clinical and clinical in-license opportunities
PhD with ≥15 years pharmaceutical industry experience, preferably within both large pharma and biotech environments, of which ≥12 years must be in a role having direct responsibilities for translational research or biomarker development and application.
Demonstrated knowledge of and history of successful application of translational research and biomarkers to the clinical development of novel agents, either small molecule or biologics, preferably within, but not limited to the Oncology, Immunology, Dermatology or Gastrointestinal Disease therapeutic areas.
Possess self-motivation, creativity and a willingness to take a “roll-up the sleeves” approach to the formulation and execution of translational medicine R&D plans.
Thorough knowledge of translational medicine and molecular diagnostics concepts, practices, and GCP & ICH guidelines.
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.
Analytical mind-set with excellent technical and problem-solving skills.
Proven experience in contributing to the overall strategic direction of an R&D organization.
Outstanding written and verbal communication and leadership skills.
Demonstrated ability to interact effectively with external clinical investigators and scientists, key opinion leaders, senior management and Board of Directors.
Ability to excel in a fast-paced, dynamic, and high-growth science-focused R&D environment.
Strong organizational and interpersonal skills.