Director, GRA CMC Pharmaceuticals, Oligonucleotides
Takeda
- Boston, MA
- Permanent
- Full-time
- Responsible for demonstrating Takeda leadership behaviors. Serve as a member of the GRA-CMC Pharmaceuticals Leadership team, giving input to key strategic, portfolio, human capital and financial decisions.
- Provide leadership of GRA CMC Pharmaceuticals – Oligonucleotides modality, and in conjunction with direct reports, manages resources, establish a CMC RA strategy and collaborate with stakeholders in global Reg CMC and across the enterprise to deliver against them.
- In conjunction with members of the team, develop high quality clinical, commercialization and LCM submissions, using proactive regulatory CMC strategies and submit them as planned.
- Build and manage relationships through active partnering with key internal (GRA, GRA CMC, Pharmaceutical Sciences, GMS, GQ etc.) and external stakeholders (Health authorities, Industry counterparts/associations, academia). Relationship management and constructive partnering with Health Authorities and relevant industry organizations to drive Takeda position and influence scientific approach and thought process to CMC topics.
- Ensure team effectiveness in working across a very complex matrix environment in GRA with CMC RA project leads and other GRA sub-functions, as needed to ensure effective strategies are developed and project execution is on target.
- Build and maintain communication strategy and platform for all staff across the organization. Responsible for timely dissemination of regulations, guidelines and data to staff and stakeholders via team sites or intranet. Actively engage and influence organization to think proactively and utilize science and risk based approach to product development and LCM activities.
- Contribute to creating and communicating an employment culture and values which attract, retain, and develop the most effective people.
- Ensure compliance with all applicable Takeda SOPs, local and international regulations, and industry best-practice.
- Represent, as required, the regulatory function in the evaluation of new product opportunities internally and externally.
- Lead or plays a key role on the relevant internal Takeda governance
- committees
- BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
- 10+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience, with international experience strongly preferred.
- Experience liaising with Regulatory Agencies having served as lead in Agency Interactions and product development meetings, international experience preferred.
- Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
- Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams.
- Ability to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
- Demonstrated leadership, problem-solving ability, flexibility and teamwork.
- Good judgement in elevating and communicating actual or potential issues to line management.
- Experience of active participation in Agency/Industry groups/forums expected.
- 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