Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

As a part of the Clinical Development team at Azurity, the Associate Director, Clinical Development - Clinical Scientist is primarily responsible for scientific and technical oversight and input to support Azurity clinical programs across multiple therapeutic areas and phases of development. In this role, the candidate will report to the Vice President, Clinical Development, and work cross-functionally with stakeholders and team members to provide scientific excellence, build effective relationships, and ensure optimal strategy and interpretation of clinical investigations.

Responsibilities:

* Design and author clinical development plans and study protocols for clinical investigations.
* Ability to understand integrated data from clinical trials including but not limited to efficacy, safety, pharmacovigilance, and clinical pharmacokinetics.
* Provide scientific input into interpretation of clinical study results, and draft and/or review clinical study reports, and collaborate with study team members to conduct timely and thorough review of study data.
* Experience preparing and presenting clinical data and findings to Executive and Senior Leadership to gain alignment on proposed action and direction for potential drug products.
* Provide clinical updates on assigned compounds/programs to Sr. Management, Project Teams, and/or Steering Committees (if appropriate).
* Draft and/or review individual study information that will be included in regulatory documents including clinical sections of IND submissions, IND Annual Updates / DSUR, Investigator Brochures, and IMPD's Draft, briefing books, clinical sections for the NDA/CTD submissions, and responses to regulatory authority questions.
* Contribute to Clinical Advisory Boards
* Key contributor to the development, review, and approval of study documents including but not limited to informed consent forms (ICF), investigator's brochure (IB), study plans, eCRFs, pharmacy and laboratory manuals, regulatory documents, statistical analysis plans, study tables, listings, and figures, and clinical study reports.
* Support all scientific aspects of Data Management, including providing scientific review to eCRFs, edit checks, line listings and database lock.
* Provide scientific review of clinical safety and efficacy data, including working with the Medical Monitor and Drug Safety to conduct Adverse Event oversight and management (including SAEs).
* Contribute to the authoring and review of clinical study associated publications.
* Present clinical trial data at professional conferences.
* Interpret and summarize pharmacokinetic data for NDA and ANDA development candidates.
* Support of In-licensing Activities, Corporate Initiatives, and Continuous Improvement.
* Create relationships with key external experts (EE's) to obtain medical and scientific input for clinical development.
* Develop relationships with appropriate consultants and External Experts and utilize these relationships to obtain feedback on protocol design and compound strategy.
* Lead development of abstracts, posters, oral presentations, and manuscripts for assigned compounds.
* Contribute or lead process improvement initiatives.
* Liaise with cross functions on training of current studies, results, meeting with lead PIs/KOLs at conferences; present as needed.
* Coordinate, lead, and provide clinical input on internal and external slide presentations to ensure consistency of content.
* Attend and present at various meetings with internal and external stakeholders (e.g., investigator meetings, scientific advisory boards, etc.).
* Develop relationships with appropriate consultants and External Experts and utilize these relationships to obtain feedback on protocol design and compound strategy.
* Clinical lead for abstracts, posters, oral presentations, and manuscripts for assigned compounds
* Contribute or lead process improvement initiatives.

Qualifications:

* Degree in scientific/life-sciences field such as Master's, PharmD, or PhD degree preferred.
* Experience and/or Training: Minimum of 10 years of pharmaceutical industry experience; minimum of 5 years of clinical experience preferred.
* Sound understanding of US and ex-US Regulatory clinical requirements.
* Demonstrates passion for research, brings innovation to challenging projects, and possesses a willingness to learn and work across diverse therapeutic areas and modalities
* Strong communication skills (both written and verbal) with an ability to express complex information clearly and concisely
* Strategic thinker who possesses rigorous scientific proficiency and solid business acumen with the ability to look beyond the current state to identify unique opportunities
* Sound understanding of the drug development continuum with through knowledge of regulatory approval processes
* Strong organizational, interpersonal and both verbal and written communication skills and ability to work collaboratively as a member of a cross-functional team.
* Exceptional analytical and problem-solving skills.
* Ability to prioritize and multi-task to meet objectives in a fast-paced company environment
* Experience in analysis of research data and publications; working knowledge of biostatistics and pharmacokinetics; working knowledge of GCP, scientific and clinical research methods and clinical study design, regulatory requirements for both adult and pediatric clinical studies

Physical & Mental Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

* Must be able to sit for long periods of time
* While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
* May occasionally climb stairs and/or ride elevators
* The employee must occasionally lift and/or move up to 25 pounds
* Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
* Other miscellaneous job duties as required
* Occasional travel (up to 5-10%) may be required

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