Medical Director or Senior Medical Director, Clinical Science - Marketed Products Group

Company: Takeda Pharmaceutical Company Ltd
Location: Boston
Posted on: April 11, 2021

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description 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 Medical Director or Senior Medical Director of Clinical Science for the Marketed Products Group in our Cambridge, MA office. The Senior/Medical Director (S/MD), Clinical Science, for the Marketed Products Group (MPG) leads and drives strategy for the overall global and regional clinical science programs of assigned Takeda products, taking into consideration the clinical development, 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 independence, based on task demands, work experience and skills, and decision-making process. The S/MD reports to the VP and Head of Clinical Science for MPG and does not have direct reports. The S/MD 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 science/development plans with the highest scientific and ethical standards and applicability to specific regulatory requirements. The S/MD interacts with and influences MPG senior leadership decision-making by setting strategic direction and updating on implementation progress and issues. Main responsibilities * 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 Clinical Research Organizations (CRO) 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 S/MD responsibilities might require Qualifications * Medical degree or internationally recognized equivalent* 5-10 years of clinical research experience (also combined) within the pharmaceutical/biotech industry or CROs.* Experience in Oncology is preferred.* Background in Clinical Development is preferred Job Posting excludes CO applicants Skills * 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 WHAT TAKEDA CAN OFFER YOU: * 401(k) with company match and Annual Retirement Contribution Plan* Tuition reimbursement* 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* Community Outreach Programs Empowering Our People to Shine Learn more at takedajobs.com. Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx No Phone Calls or Recruiters Please. #LI-JV1 Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time

Keywords: Takeda Pharmaceutical Company Ltd, Boston , Medical Director or Senior Medical Director, Clinical Science - Marketed Products Group, Executive , Boston, Massachusetts