Lexicon Pharmaceuticals is currently recruiting for an Executive Director, Regulatory Strategy to develop and lead regulatory strategy for Lexicon’s portfolio of products. This position will be located in the Basking Ridge, New Jersey office.
JOB SUMMARY:
The Executive Director, Regulatory Strategy will be accountable for developing and executing the global regulatory strategy for Lexicon’s products. This individual will be the key interface between Lexicon and regulatory agencies worldwide regarding investigational and marketed products and will collaborate effectively with development partners and vendors to ensure the success of our development projects. The Executive Director will report to the Senior Vice President of Regulatory Affairs and Quality Assurance, and will work closely with Lexicon’s senior management team, including the Chief Medical Officer, Chief Commercial Officer, and Clinical Operations leader in setting regulatory strategies. They will be responsible for the management of all regulatory personnel and regulatory activities relating to assigned development stage programs. He/she This individual will be responsible for ensuring that Lexicon remains in compliance with regulatory obligations.
KEY RESPONSIBILITIES WILL INCLUDE BUT NOT LIMITED TO THE FOLLOWING:
Required Skills Required Experience
QUALIFICATIONS:
Master's, Pharm D, MD, or PhD Degree in Life Sciences or related discipline
15+ years of experience in Pharmaceutical industry, including drug development experience and at least 10 years of experience in leading regulatory teams and participating in cross-functional development teams with demonstrated success in regulatory authority submission strategy, execution, and health authority interaction.
Detailed knowledge of FDA/EMA/ICH regulations and guidance for drug development and regulatory policy
Experience in developing regulatory strategy for multiple therapeutic area indications and translating into regulatory project plans for key deliverables that integrate with overall development plans
Experience in developing and submitting European regulatory documents including Scientific Advice, PIP, pre-MAA and MAA submissions
Able to contribute to and critically review regulatory scientific documents across the non-clinical, CMC and clinical disciplines
Able to critically evaluate key business/scientific challenges and develop and complete complex, ambiguous initiatives having cross-functional impact
Able to articulate a compelling strategic vision to their team that motivates, excites and inspires them to bring their best to Lexicon every day
Effectively deploys, allocates and manages resources including outstanding budget management
Possesses a high level of attention to detail, excellent verbal and written communication skills, and strong negotiation and influencing skills
Able to travel to and from New Jersey and/or Texas and as required to meet with regulatory authorities as needed
Experience in all phases of development across multiple therapeutic areas including preparation, submission, and support of INDs, NDAs, and MAAs.
Possesses excellent scientific and business judgment; recognized as an internal thought leader with extensive technical and business expertise within a strategic organization
To apply, please visit the careers section of our website: https://lexpharmacareers.silkroad.com/.
For additional information about Lexicon and its programs, please visit www.lexpharma.com.
Lexicon is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
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Lexicon Pharmaceuticals, Inc. is a drug-free workplace. Candidates are required to pass a drug test, background check and verification of credentials before beginning employment.
This position requires the ability to stand for long periods of time, lift a minimum of 50 lbs. Major attributes of the position are punctuality, professionalism within their field and ability to work overtime as needed.
Consigli is an equal opportunity employer.
We evaluate qualified applicants without regard to race, color, religion, sex,
sexual orientation, gender identity, national origin, disability, veteran status, and other protected characteristics.