Medical Director / Sr. Medical Director

Location : Newton, Ma

Position and Scope

Seeking a Medical Director and Senior Medical Director to join their company as critical members of their clinical development team. The Senior Medical Director will report to the Company’s President and Chief Scientific Officer. Successful candidates will work closely with the clinical development team, contract research organizations, clinicians and patients to ensure that the Company’s clinical trials are progressing according to plan. These positions will be responsible for providing clinical leadership in developing and executing global clinical trial strategies for Karyopharm drug development candidates. They will be responsible for the strategic planning phase through conducting and reporting of trial results including the design and implementation of protocols, guiding internal staff, working with external partners and vendors and collaborating across functional departments to ensure the successful execution of trials.

 

Specific Responsibilities

· Develop clinical strategies and implementation plans, in partnership with both internal and external resources to achieve the Company’s strategic and tactical goals/objectives

· Provide “hands on leadership” to the clinical team for the successful planning and execution of each clinical trial

· Monitor trials to ensure all data collection, compilation, and summarization adheres to protocols and GCP standards

· Work with clinical team and other resources to select trial investigators and clinical sites

· Monitor clinical trial sites as necessary

· Participate in the development of near-term and long-term planning of new clinical trial opportunities

· Ensure that appropriate resources are utilized to provide expert and timely support of clinical trials, including the selection and management of external entities (such as CROs and other vendors) and also identifying/hiring employees, contractors, etc.

· Meet established timelines and budgets.

· Attend clinical, scientific, and investigator meetings representing the company as a medical expert regarding drug development candidates

Position Requirements & Experience

· MD with clinical training in internal medicine and hematology / oncology; board certification desirable

·  Experience designing and reviewing clinical trial protocols Previous experience conducting clinical research involving drug development candidates for pharmaceutical / biopharmaceutical companies, global clinical trial experience would be ideal

Clinical experience managing cancer patients

· Experience managing and interacting with Contract Research Organizations

· This position requires rapid response to clinical investigators and patients involved in the company’s trials

· Some travel to investigator sites and scientific meetings will be required

 

 

Personal Characteristics & Cultural Fit

· Candidates need to be very hands on in this “roll-up the sleeves and get it done” company

· Entrepreneurial, rapid paced company environment, highly focused and responsive to patients and clinical trials

· Everything is about the patient – must have passion around the patient

· Very collaborative clinical team

· Strong sense of urgency and initiative

· Creative problem solving

· Excellent communication skills – presenting, listening and writing