Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Medical Director, Clinical Science for the Marketed Products Group in our Cambridge, MA office.
The Associate Medical Director (AMD), Clinical Science, for the Marketed Products Group (MPG) leads and drives strategy for the overall global and regional clinical development programs of assigned Takeda products, taking into consideration the medical, scientific, regulatory and commercial issues. She/he is expected to work in a collaborative fashion across different functions and levels of management but able to accomplish tasks with the delegated level of independence, based on work experience and skills, decision making process, and contingent needs/opportunities.
The AMD reports to the VP and Head of Clinical Science for MPG and does not have direct reports.
The AMD leads a multi-disciplinary matrix team through simple and complex decisions, by assessing and integrating input from various functions and disciplines with the goal of creating and executing clinical development plans with the highest scientific and ethical standards and applicability to specific regulatory requirements. The AMD interacts with and influences MPG senior leadership decision-making by setting strategic direction and updating on implementation progress and issues.
Clinical Science activities related to the planning of clinical trials, including preparation and presentation of clinical trial synopses and protocols for review and approval by MPG senior leadership
Oversight of medical monitoring activities, assessment of issues related to protocol conduct and individual subject safety and toleration, preserving the highest standard of scientific integrity and ethics
Assessment of overall safety data for assigned products in collaboration with Safety and Pharmacovigilance
Interpretation of results of clinical trials and internal subject matter expertise for the assigned products and related therapeutic area also for potential due diligence assessment of licensing opportunities
Resource to Clinical operations for direction and management of collaborations with CROs and other cross-functional team members involved in the execution of clinical trials
Resource to Regulatory affairs for expertise, responsibility and leadership on preparation and presentation of clinical/medical components of regulatory filings and for interactions with Regulatory Authorities
Presentation of study results to internal and external audiences and assessment of study results’ impact on the overall product strategy
Identification, engagement and management of key opinion leaders relevant to assigned products and therapeutic area for the consultation needs that the AMD responsibilities might require
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
MD or internationally recognized equivalent with 3-5 years of clinical research experience (also combined) within the pharmaceutical/biotech industry, CROs, academic institutions, hospitals, or other settings of clinical practice
Superior communication, strategic, interpersonal and negotiating skills
Ability to proactively predict/identify issues and research/understand their root causes
Pragmatic approach to problem solving
Ability to drive decision-making within multi-disciplinary, matrix teams, while stimulating feedback and respecting diversity and potential differences of input
Diplomacy and positive influencing abilities
Estimated up to 5 travel times per year, including possible international travel.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days