Exec Director / VP of Clinical Development -Medical

Hiring Manager: Chief Medical Officer
Date Opened: February 2019

Position Summary:

The Executive Director or Vice-President of Clinical Development is responsible for strategic leadership and tactical execution of the clinical development plan for assigned development programs. The successful candidate also will work closely with the Clinical Operations Lead on all aspects of development program oversight and management. The position requires excellent leadership, depth of experience in all phases of drug development especially in early phase trials, and a broad background in clinical medicine. Therapeutic expertise in one or more of the areas outlined in Qualifications is desirable, but not an absolute requirement.

Roles & Responsibilities:

  • Leads clinical programs in partnership with a Clinical Operations Lead of development assets from the IND-enabling stage through Phase 2 proof-of-concept

  • Designs and implements clinical research strategies and is accountable for the development and execution of clinical research programs for novel agents in a variety of therapeutic areas and disease states

  • Directs study design, protocol development and implementation of clinical studies

  • Defines in partnership with a Clinical Operations Lead clinical study parameters, deliverables, and resource needs

  • Reviews and evaluates clinical research results to inform development strategy, operational tactics and future marketability

  • Serves as the medical monitor for a subset of portfolio assets

  • Oversees evaluation of adverse events for overall assessment of benefit-risk

  • Contributes to the preparation of submission documents for INDs and CTAs to regulatory agencies

  • Acts as a liaison between Boston Pharmaceuticals and clinical investigators / KOLs

  • Ensures that all activities are in compliance with GCP’s and company SOPs

  • Represents Boston Pharmaceuticals at key international and national medical and scientific meetings including participation and/or leadership of 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

Qualifications:

  • MD or MD-PhD with 10+ (VP) / 6+ (ED) years industry experience, preferably within both large pharma and biotech environments

  • Demonstrated knowledge of and history of success in clinical development of novel agents, either small molecule or biologics, preferably within, but not limited to the immunology, oncology, infectious diseases, or gastrointestinal disease therapeutic areas

  • Prior experience with preclinical or clinical asset evaluation as part of scientific due diligence in one or more specific therapeutic areas is strongly desired

  • Possess self-motivation, creativity and a willingness to take a “roll-up the sleeves” approach to the formulation and execution of clinical development plans

  • Thorough knowledge of clinical research concepts, practices, and GCP & ICH guidelines

  • Experience working with internal and outsourced matrix-structured clinical development teams.

  • 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, 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