Cytokinetics is dedicated to upholding the highest standards of excellence to bring potential medicines to patients to improve outcomes and quality of life. We are looking for Regulatory Affairs professionals who bring a strategic mindset and a deep understanding of the regulatory environment. As a member of the team, you will play a crucial role in ensuring our processes meet regulatory requirements while maintaining high standards of compliance.

Cytokinetics is seeking an experienced Director, Regulatory Affairs Europe to join the Regulatory Affairs team in Europe. He/she will provide leadership in developing and executing best in class regulatory strategies for assigned programs in the European region. The Director will lead regulatory activities related to the submission of Marketing Authorization Applications of assigned Cytokinetics products in Europe  as well as implementation of post-marketing requirements.

The Director, Regulatory Affairs Europe will work closely with the Global Regulatory Lead and be a member of the Global Regulatory Team. He/she will work cross-functionally including with Clinical Research, Medical Affairs, Drug Safety, Quality, Market Access and with country operations to ensure all regional and local regulatory requirements are met.  

The Director will also maintain awareness of the regulatory environment and communicate the impact of changes on business and product development programs.

This position offers a temporary contract till end of the year, with possibility of extension. The work set up is hybrid, with 2-3 days per week in our centrally located Zug office, and the rest of the time from home.

Responsibilities

• Develop a robust European strategy for specific products aligning with the Global regulatory strategy and cross functionally identify the best strategy that will lead to European approval.
• Contribute and independently execute the filing plans for Europe in line with corporate, regional and local business objectives.
• Ensure high-quality regulatory submissions are made on time and meet Cytokinetics requirements.
• Collaborate with the Regulatory Study Lead to review and provide strategic input/advice to EU CTR submissions and/or queries.
• As part of the Global Regulatory Team (GRT), provide direction and expertise on regional and local regulatory mechanisms to optimize product development
• Provide strategic and operational contributions to EMA/national agencies interactions and their preparation
• Maintain an awareness of new and developing legislation, regulatory policy and technical guidance relating to Cytokinetics products and discuss their implications with business.
• Oversees regulatory-related launch and post-marketing activities in the EU:
• Provides regulatory input to market access strategy and HTA plans and submissions in the EU
• Ensures all post-marketing requirements and maintenance activities are met.
• Work closely with the Quality department on relevant regulatory procedures applicable to the European region

Qualifications

• Seasoned professional with a minimum of 10 years of relevant experience with a solid expertise and knowledge of the applicable European regulatory regulations, directives and guidelines.
• Bachelor of Science in a scientific discipline, Pharm D (/Pharmacist) or PhD preferred. Fluency in English, and any other key EU market languages are an advantage.
• Proven track record of directly leading Marketing Authorization Applications through EMA centralized procedure and national agencies (including Switzerland and UK). Experience in international markets is advantageous.
• Strong experience leading or participating in regulatory agency interactions.
• Solid foundation in science obtained through academics and business experience.
• Must be a strong team player, a fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Strong interpersonal capabilities and ability to build and maintain networks.
• Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.

#LI-HYBRID

Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Ironwood is also advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure. Building upon our history of GI innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs. 

Founded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, and has operations in Basel, Switzerland.

Purpose/Summary: The Clinical Operations Lead owns program delivery & operational CRO/vendors oversight oof one or more development programs.

The Clinical Operations Lead has hands-on accountability and responsibilities in overseeing clinical trials execution within the program(s), especially the oversight of the trials/Program CRO, consultants and contractors to secure excellence in the delivery of their services to meet the trial milestones while adhering to quality, timeline, and budget. Leads by example with strong partnering and communication capabilities.

Key responsibilities:

• Takes a lead role in managing clinical program(s) and collaborating globally and across departments such as clinical development, regulatory, data management, biostatistics, drug supply, medical writing, and drug safety, etc.
• Supports creation and maintenance of the clinical development plan in collaboration with the Clinical Development Lead by providing input on operational aspects of the program and trials, including, but not limited to, budget, timelines, and vendors.
• Oversees CTT performance, including metrics, milestones and compliance with relevant regulatory standards, including ICH‑GCP, protocol requirements and company procedures.
• Collaborates with the Global Clinical Trial Managers (gCTM) and functions in the following activities, among others:
  • Support decision-making in the selection of study
  • oversight of CROs, vendors, consultants and contractors, including negotiation of Scope of work (SOW), ensuring delivery against contracted SOW, budgets, performance management and issue
  • Development and management of program timelines, budgets and
  • Oversight of trial subject retention
• Constantly scans for possible risks and implementation of mitigations; while identifying best practices and opportunities for trial efficiencies and opportunities for enhanced quality.
• Leads by example, onboarding, coaching, and mentoring other Development Operations team members, , fostering a team culture of ownership, engagement, and continuous improvement, ensuring recognition of team successes.
• Provides immediate supervision and line management to one or more employees, , including employee development, company goal setting, and performance management processes.
• Contributes to strategic vision and long-term plans of Development
• Supports in determining the best utilization and prioritization of resources, and the optimal organization of infrastructure and staff, leveraging experience working in varying resource models (i.e. Hiring, Functional Service Provider, CRO Full Package Outsourcing, etc.).
• Identifies and eliminates any impediments that obstruct or distract the team from delivering value; report and escalate issues, concerns, and roadblocks to management as needed.
• Regularly interacts with senior management on matters concerning functional areas and/or vendors.
• Contributes with the development and implementation of policies and standard operating procedures (SOPs) to be used in Development Operations
• Other duties as assigned

Prerequisite Education, Experience, & Skills:

• A highly motivated and results-oriented leader with a Bachelor’s degree and 14 years of pharmaceutical/Biotech clinical development and operations experience.
• Broad experience in global level clinical trial management, and knowledge of principles and practices of Program and Project Management. 
• Significant experience managing all aspects of activities in Phase I-IV trials, oversight of CROs and vendors at global level.
• Advantageous to have rare disease trial experience.
• Proven ability to effectively manage a large team comprised of permanent employees, consultants, contractors and oversight/partnering with CROs and teams within their varying levels.
• Intense drive and organizational expertise are necessary to manage the diverse group of functional activities involved in the international clinical trials program.
• Strong proficiency in GCP/ICH, U.S. drug development process and regulatory expectations related to global clinical trials execution .
• Excellent interpersonal, oral, and written communication skills.
• Ability to drive high-level decision-making, think strategically, and take initiative in the face of incomplete information
• Able to motivate teams to do their best work through active collaboration, healthy debate, and continued learning.