The Therapeutic Area Lead is responsible for a group of Medical Doctors and oversees all medical aspects of the clinical programs of a compound developed for indications within the neuromuscular franchise, thus maximizing both expertise and resource efficiency. This includes strategic input in the different Target Product Profiles (TPP), Clinical Development Plans (CDP) and regulatory documents. Works in close collaboration with the Neuromuscular Franchise Lead, in order to provide high-quality clinical development plans that can reliably be executed within time and budget, and lead to successful registrations.
Roles and Responsibilities:
Lead, coach and structure a group of highly qualified medical doctors within a compound and across indications, resulting in an expert team of medical developers within the neuromuscular therapeutic area.
Medical point of contact for senior management and business development when expertise in the therapeutic area is needed. This may include due diligences.
Oversee and guide the strategic medical input, execution, as well as interpretation of the clinical programs.
Responsible for harmonization of practices and increasing efficiencies across the therapeutic area.
Senior Medical expert point of contact for all internal and external stakeholders.
Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP.
Closely collaborate with the Neuromuscular Franchise Lead and other development functions in order for medical vision, risks, issues, and results to be aligned with and clear to all involved parties.
Education, Experience and Qualifications:
Medical Doctor; relevant specialty education (neurology/neuromuscular).
Industry experience for 8-10 years.
Excellent English, both written and spoken is a must, as well as ability to travel.
Proven interpersonal skills enabling him/her to work in teams, including other medical doctors, while recognizing 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 organization.
Strong communication skills to ensure close collaboration with the cross-functional team members so that Development and 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 actions.
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