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