Director, Strategic Clinical Development

Location: California
Director, Strategic Clinical Development page is loaded## Director, Strategic Clinical Development remote type:
Hybrid locations:
RTP, NCtime type:
Full time posted on:
Posted 2 Days Agojob requisition :
R04335

California, US residents .
** The job details are as follows:
**** Who We Are
** We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.

United Therapeutics (Nasdaq:
** UTHR**) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (
** PAH**). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (
** PH-ILD**) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (
** PF**).The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

** Who You Are
** The Director, Strategic Clinical Development will support development and execution of clinical development strategy for all assigned programs from inception (Phase 1-3) to successful product approval by the FDA and other regulatory agencies.
* Design and review clinical protocols, data analysis plans, interpretation of results, clinical study reports, and supporting work for sections of regulatory submissions, such as, INDs, CTAs, NDAs, MAAs and regulatory agency briefing packages, etc.
* Prepare, present, and defend complex aspects of protocol design and/or study data at investigator and internal meetings
* Prepare and review draft abstracts and manuscripts for publication in consultation with other team members/collaborators
* Assist in researching and drafting of sections or entire documents, as assigned, such as DSURs, other study reports and documents, investigator brochures, etc.
* Critically analyze and synthesize complex information from reviews of the scientific/clinical literature
* Collaborate with Medical Science Liaisons and other company staff in identifying key partners for future research studies/projects
* Manage and support Clinical Operations resources in evaluating, selecting, and engaging research-oriented investigative sites for company-sponsored studies and future research projects
* Attend appropriate external scientific events to maintain awareness of research activities and represent a project and/or the company
* Participate in cross-functional teams, departmental meetings, and regulatory meetings
* Offer scientific insights into therapeutic areas and disease specific information as required
** For this role you will need
** Minimum Requirements
* Doctor of Philosophy (PhD) , Pharm

D, MPH, or RN in life sciences
* 10+ years of experience in pharmaceutical/biotech industry clinical research/development with a PhD or Pharm

D or
* 12+ years of experience in pharmaceutical/biotech industry clinical research/development with a MPH or RN
* Experience with development of clinical trial protocols, CSRs, abstracts, and manuscripts
* Experience in the preparation of regulatory applications (e.g. IND, CTA, NDA, MAA, and agency meeting packages)
* Knowledge of GCP and regulatory guidelines
* Knowledge of clinical science as applicable to drug development
* Medical, scientific, and/or regulatory writing experience
* Excellent interpersonal communication skills (written, verbal, and presentation)
* Ability to thrive as both a manager and…