Director, Global Regulatory Lead, Cardiovascular or Metabolics (or IM) ** San Francisco or Tri State East Coast
Expiry Date: 04-10-2022
Salary: On Application
Job Type: Full Time
San Francisco County
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About my Client:
My client is a well-known, household name, a top 20 R&D based Biotech company, with many successes under their umbrella and a wide and diverse pipeline which includes CARTs, mAbs, NCEs and ADCs in multiple therapeutic areas. They are looking for an individual who is already at Director Grade or very close to it, and wants to work at the project / product level with Global Strategy and Regulatory Leadership and a member of the core project development team. You will define global regulatory strategies and serve as the RA sub team lead for major submissions, including NDA/BLA/MAA submissions for first submissions and new indications. The company have several high value brands in these therapy areas, as well as 6 NMEs in development half in late phase.
It’s highly preferred to have a candidate in the US at one of the following locations: NJ or SFF / Brisbane, California.
About the Role:
- Support the preparation of, and participate in / lead (as appropriate), key health authority (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.
- In collaboration with the global regulatory team (GRT), develop global submission plans and Health Authority interaction plans ensuring they align with strategy liaison input..
- 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.
Degree / Experience Requirements
- Bachelor’s degree required; advanced scientific degree preferred (Masters, PhD, PharmD, BSN, etc.) with experience of leading either US or US and EU regulatory strategies.
- Understanding of scientific content and complexities and good knowledge of cardiovascular 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.
- Track records of issue resolutions with main regulatory authorities; demonstrated ability to break down complex, scientific content into logical components.
- 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.
- 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. Experience utilizing leadership techniques to drive a team through the stages of team development.
- 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).
- Demonstrates ownership of results within (and beyond) area of responsibility and holds self and others accountable for decisions and results achieved, looking for opportunities for continuous improvement.
Package & Relocation
My client will buyout losses including stock and bonus, and they provide a decent package with a yearly stock plan which is RSUs, Share Options and a decent bonus plus they offer a fill relocation package if needed from anywhere in the USA to one of these two hubs.
To apply for this role, please contact me Matt Greig or Javier Monfort, on 908.332.9157, or press the red “Apply for position” button, or send us a copy of your resume to CV@advtalent.com. We will support you throughout the interview and on-boarding process!
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