We are an EasyHiring recruiting company that is looking for candidates for our partners for the position of Director, Global Regulatory Science - Oncology in Massachusetts - Brookline for work in Cambridge, Massachusetts

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at our company is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

We recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Position Summary

Leadership responsibility for global regulatory strategy within a development team (DT).

Position Responsibilities

• Leadership responsibility for global regulatory strategy within a development team (DT).
• Serve as team lead or co-lead of marketing application submission teams for indications that are at the regulatory filing stage; helping to develop strategy and content for global dossiers.
• Support the preparation of, and participate in / lead (as appropriate), key HA interactions. Assure consistent positions on common issues are presented to global HA. Review and approve content of responses to queries from HAs for respective regions/countries
• Prepare content for regulatory strategic documentation and Regulatory Project Reviews. Align regulatory plans with commercial and development plans
• Develop target labeling and co-lead the cross-functional labeling team.
• Ensure consistent positions are presented in responses to global health authority (HA) queries.
• Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input.
• In collaboration with the global regulatory team (GRT), develop global submission plans and Health Authority interaction plans.
• Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters, IBs, DSURs, etc.
• Co-lead the cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines.

Requirements

• Solid scientific background, Ph.D., M.D., PharmD, MS, or BS
• Significant experience in regulatory affairs (e.g. > 4-7 years)
• Understanding of scientific content and complexities and good knowledge of Oncology drug development is desired.
• Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Product Development and Commercialization process.
• Understanding of policy, laws, regulations and guidelines as they apply to Regulatory Agencies globally for drug development and approval.
• Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment.
• Experience in successfully leading teams; Demonstrated ability to drive quality decision-making. Demonstrated ability to organize / prioritize tasks.
• Demonstrated ability to negotiate with and influence others. Demonstrated ability to facilitate issue resolution and conflict management. Direct experience in developing strategy and leading teams through interactions with health authorities.
• Track records of issue resolutions with main regulatory authorities; demonstrated ability to break down complex, scientific content into logical components.
• Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives.
• Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies.
• Ability to broadly represent department functions on project team in a matrix organization. Demonstrated ability to coordinate global activities.
• Experience as a member of GRTs, project working groups, or comparable experience. Experience developing strategy for product partnership (out-licensing, divestiture, co-development, in-licensing, and acquisitions).
• Experience utilizing leadership techniques to drive a team through the stages of team development.

Other Qualifications:

• Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional and geographic boundaries to achieve company goals.
• Communicates opinions, facts and thoughts with clarity, transparency and honesty
• Demonstrates ownership of results within (and beyond) area of responsibility.
• Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
• Looks for opportunities for continuous improvement.

#LI-Hybrid

The starting compensation for this job is a range from $173,000 to $257,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

Job Type: Full-time

Work Location: On the road