Global Medical Indication Lead

job
  • Planet Pharma
Job Summary
Location
Boston ,MA 02298
Job Type
Contract
Visa
Any Valid Visa
Salary
PayRate
Qualification
BCA
Experience
2Years - 10Years
Posted
03 Jan 2025
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Job Description

Remote EST but will need to able to travel to Boston, MA monthly

Full time, permanent position


Job Description:

The Global Medical Indication Lead leads Clinical Development for the XXXXX ALS indication: translating the Target Product Profile (TPP) as set by the Asset Strategy Team into a Clinical Development Plan that answers the relevant questions safeguarding time, quality and budget, in close collaboration with the other members of this cross functional team, in order to maximize the potential of the Asset for a given indication.


This is a hybrid role and will have frequent trips to the Boston office. EST time zone required.


Roles and Responsibilities:

Provide continuous strategic medical insight and planning for the indication during all the stages of development


Own and lead the Clinical development plan. Participate in long range strategic planning as data emerge in the indication


Line management of the Global Clinical Trial Physicians working on the indication: coach and set example for their roles ensuring high quality medical support for the study teams, identify high performers for potential other roles


Real time oversight of the medical aspects of studies in the indication including the relevant communication to management as well as the different study teams


Safeguard harmonization across the studies so that communications to external stakeholders (e.g. questions of IRBs, RAs) are consistent and company efficiency is maintained in close collaboration with peers as well as management of the different functional groups


Lead indication medical ad boards as appropriate


Help build and maintain a “best in class” group of development medical doctors


Ensure compliance of all studies in the indication


Education, Experience and Qualifications:

Medical Doctor; relevant specialty education (Neurology/Neuromuscular, with ALS experience preferred), having acquired in-depth understanding of end to end (phase I to registration) drug development based on relevant experience of at least 3-5 years in the pharma/biotech industry as well as clinical practice. Clinical Development experience in ALS preferred


Excellent English, both written and spoken is a must, as well as ability to travel


Proven leadership, motivational and interpersonal skills in a global and intercultural environment, including leading through influence (without having direct reporting lines), and managing direct reports


Pro-active problem solver with negotiation skills


Must provide clear vision, direction, and purpose to the different study teams, demonstrated expertise in clinical trial design, conduct and interpretation of clinical data


Strong communication skills to ensure 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


Executes his/her responsibilities with knowledge, accuracy, persistence, resilience and creativity, being an accomplished team player whilst maintaining medical integrity


Demonstrated expertise in clinical trial design, conduct and interpretation of clinical data


pay within this range will be commensurate with level of experience

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