Associate Medical Director, Clinical Science, NS TAU
BioSpace · Cambridge, MA · 3 wk ago
Healthcare$199k–$312k/yrFull-time
About the role
The Associate Medical Director leads and drives strategy for clinical studies within the overall global clinical development for assigned Takeda pipeline compound(s) taking into consideration the medical, scientific, regulatory and commercial issues. They represent Clinical Science on Study Execution and Clinical Teams and may serve as co-leader of these teams. They interact with and influence Neuroscience Therapeutic Area Unit senior leadership decision-making by contributing to strategic direction.
Responsibilities
- Represents Clinical Science on Study Execution and Clinical Teams and may serve as co-leader of these teams.
- Serves as an advisor to other clinical scientists involved in these activities, and be accountable for the successful design and interpretation of clinical studies.
- Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
- Presents study conclusions to Management and determines how individual study results impact the overall compound strategy.
- Oversees all Clinical Science activities relating to the preparation / approval of Synopses, Protocols and the conduct of clinical studies.
- Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety.
- Directs interactions with key opinion leaders relevant to assigned compounds and therapeutic area.
- Contributes to the development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities, interacts with upper management of potential partner/acquisition companies during DD visits and alliance negotiations and represents clinical science on internal assessment teams.
- For ongoing alliance projects, will interface with partner to achieve Takeda’s strategic goals while striving to maintain good working relationship between Takeda and partner.
Qualifications
- MD, MD/PhD, or internationally recognized equivalent plus 3 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
- Previous experience successfully leading matrix teams preferred.
- Previous experience in designing and executing first in human and early proof of concept trials preferred.
Skills
- Superior communication, strategic, interpersonal and negotiating skills.
- Ability to proactively predict issues and solve problems.
- Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams.
- Diplomacy and positive influencing abilities.
Knowledge
- Neurology Therapeutic area knowledge preferred.
- Specialization in Neurology preferred.
- Subspecialty expertise in neuromuscular disease or neurodegenerative disease preferred.
- Regional/global Regulatory requirements.
- GCP/ICH.
Benefits
Takeda offers a comprehensive benefits package including:
- U.S. Base Salary Range: $198,500.00 - $311,850.00
- Short-term and long-term incentives.
- Medical, dental, and vision insurance.
- A 401(k) plan and company match.
- Short-term and long-term disability coverage.
- Basic life insurance.
- A tuition reimbursement program.
- Paid volunteer time off.
- Company holidays.
- Well-being benefits.
Pay
$198,500.00 - $311,850.00
Schedule
Hybrid