Senior Manager, CMC Project Management

Employer
Location
Waltham, MA
Salary
Competitive salary and benefits
Posted
Jun 02, 2018
Closes
Aug 02, 2018
Education
BS, MS
Career Fair Category
Career Fair

Senior Manager, CMC Project Management

There is nothing conditional about what we do.
Or who we are.
Or how we treat you.
We do what’s right.
We put science for patients first,
disrupting the model to go beyond
the concepts of conventional care.
We don’t treat a condition.
We treat people & partners.
We care to change the future.

Your Impact at TESARO:

The CMC Project Manager will be responsible for operational leadership of cross-functional CMC project sub-team(s).  S/he will ensure that the CMC project(s) are defined and implemented per the defined strategy and work closely with the technical CMC Lead to build, implement and execute the CMC project strategy and plans.  S/he will work with internal and external stakeholders to define, manage and interpret results for CMC-related activities in support of global clinical development and registration.

Job Responsibilities:

•     Provide CMC operational leadership, tactical oversight, and guidance to program teams and management to support global program development.

•     Work with the CMC Lead and cross-functional area experts to develop CMC strategies and design development work or studies.

•     Manage the integration of defined CMC activities within CMC sub-teams and with the overall program development teams.  Operationalize the CMC strategy and keep the team aligned.

•     Build detailed CMC timelines with clarity to assumptions, risks and decision points.

•     Support CMC area objectives, budgets and resource plans.  Manage the CMC budget for programs through collaboration with consultants, contractors, and internal associates.

•     Work with CMC functional leads to review strategies and manage tactical execution.  Link discrete CMC strategies into a single, comprehensive strategy across the areas of drug substance, drug product, analytical, clinical supply chain, regulatory and quality.

•     Establish and lead cross-functional CMC teams for assigned programs. Provide technical project management including Gantt and budget development, critical path analysis and risk mitigation.

Requirements:

•     B.S. with 8+ years or M.S. with 5+ years of relevant experience as a CMC project manager and/or pharmaceutical functional area scientist.

•     Proven leadership and cross-functional management of CMC projects, including demonstrated leadership in more than one CMC specialty, and extensive experience with vendor management.

•     In-depth knowledge of cross-functional drug development processes, FDA/ICH/EMA guidelines and cGMPs.

•     Working knowledge CMC development strategies across IND-NDA stages and of global requirements for IND and NDA submissions (or their regional equivalents).

•     Experience in preparation and submission of CMC documents in support of regulatory filings. 

TESARO is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

FOR MORE INFORMATION, PLEASE CONTACT US AT careers2@tesarobio.com

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