Clinical Trial Physician – Neuromuscular Job Boston area,Massachusetts USA,Doctor/Physician

Position purpose

Provides clear medical leadership in the Study team, working in close collaboration with the other members of this cross functional team, in order to provide reliable, high quality study data within time and budget .

Key Accountabilities/Responsibilities:

Provide medical leadershiptothestudy teams , including creating clinical trial protocols while implementing thelatestscientificinformation, contribute to site selection , contribute toreview and approval ofstudy protocolsandamendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions and other clinical documents as required for the conduct of clinical trials

Real time Medical Monitoring of clinical studies: ensure medical validity of each individual primary endpoint as wellstudy subject safety, while ensuring medical issues are identified early . Pro‑active escalation and correction of issues in consultation with the Global Medical Indication Lead

Interpret the clinicaltrialdata for regulatory documents (e.g.CSR,INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required, in consultation with the Indication Lead

Medical point of contact for all internal and external stakeholders:
Interact with the investigators as needed, answer questions of IRBs and Health Authorities, prepare and present material to the study executive and independent safety committeeifapplicable; medical training of site staff at Investigator meetings; CRA training in new indications

Ensure study compliance for all medical aspectsby understanding and applying all relevant SOPs and GCP

Closely collaborate with the cross functional study team members in order for medical risks, issues, and results to be clear to all involved parties

In case more than 1 physician is working on the protocol , a primus inter pares will be appointed and he/she will ensure that answers to questions from sites /IRBs RAs, eligibility and protocol deviation decisions will be harmonised across medics

Desired

Skills and Experience:

Medical Doctor; relevant specialty education preferred ( e.g. neurology, hematology, dermatology , immunology, rheumatology, internal medicine, pediatric, )
Some experience in industry preferred
Excellent English, both written and spoken is a must, as well as ability to travel.
Proven interpersonal skills enabling to lead a study team, while recognising individual expert competencies, providing medical advice and evaluations exercising judgement in which issues need to be escalated immediately
Pro‑active problem solver with negotiation skills , remaining sensitive to the different cultural needs in a global organisation
Strong communication skills to ensure close collaboration with the cross functional team members so that study plans and status are transparent, and that risks, issues, and results are clear to all involved parties. A matrix structure requires additional skills in gathering decision information, negotiation and communicating decisions and action,