Clinical Trial Physician – Immunology/ auto-immune

Planet Pharma; Boston (MA); In loco; USD 180.000 - 250.000; Tempo pieno

Descrizione del lavoro

Planet Pharma is seeking an MD to lead medical efforts within a cross-functional Study team. You will craft protocols, monitor safety and data quality in real time, and interact with investigators, IRBs, and Health Authorities. This role requires strong leadership, expert medical judgment, and the ability to travel as needed.

You will liaise with Indication Leads and Regulatory teams to prepare CSRs, NDAs, and manuscripts while ensuring compliance with SOPs and GCP throughout the trial lifecycle.

Competenze

• Must hold an MD with relevant specialty training preferred (e.g. neurology, hematology, dermatology, immunology, rheumatology, internal medicine, pediatrics).
• Excellent command of English (written and spoken).
• Proven ability to lead a study team and provide medical advice.

Mansioni

• Provide medical leadership to study teams, develop protocols with up-to-date scientific information, contribute to site selection and protocol approvals.
• Real-time medical monitoring of studies, ensure endpoint validity and participant safety, escalate issues with Global Medical Indication Lead as needed.
• Interpret clinical trial data for regulatory documents and publications in consultation with Indication Lead.
• Serve as medical point of contact to investigators, IRBs, Health Authorities; participate in investigator meetings and staff training.
• Ensure medical compliance with SOPs and GCP; collaborate with cross-functional team to clarify risks and results.
• Lead harmonization of medical questions across sites when multiple physicians work on a protocol.
• Collaborate across functions to ensure transparency of study plans, risks, and results for all stakeholders.

Conoscenze

Interpersonal skills

Leadership

Communication

Problem solving

Willing to travel

Formazione

Medical Doctor

Descrizione del lavoro

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:

1. Provide medical leadershiptothestudy teams , including creatingclinical trial protocols whileimplementing 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 decisionsand other clinical documents as required for the conduct of clinical trials
2. Real timeMedical 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
3. 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
4. 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
5. Ensure study compliancefor all medical aspectsby understanding and applying all relevant SOPs and GCP
6. Closely collaborate with the cross functional study team members in order for medical risks, issues and results to be clear to all involved parties
7. 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,