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United Therapeutics Corporation · 16 hours ago

Director, Strategic Clinical Development

Triangle Area

Full-time

Hybrid

Director/Executive

10+ years exp

United Therapeutics Corporation is a pioneering biotech company focused on developing novel pharmaceutical therapies and technologies for organ transplants. The Director of Strategic Clinical Development will lead the clinical development strategy for assigned programs from inception to product approval, overseeing various clinical protocols and collaborating with cross-functional teams.

BiotechnologyPharmaceuticalTherapeutics

Comp. & Benefits

Hiring Manager

William Neutzling

Responsibilities

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

Qualification

PhDPharmDMPHRNClinical trial protocolsRegulatory applicationsGCP knowledgeMedical writingAnalytical skillsInterpersonal communicationMicrosoft Office SuiteLiterature searchesTeam managementAttention to detail

Required

Doctor of Philosophy (PhD), PharmD, MPH, or RN in life sciences

10+ years of experience in pharmaceutical/biotech industry clinical research/development with a PhD or PharmD 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 a team member

Ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines

Strong analytical skills

Ability to speak and write in English fluently

Attention to detail and a commitment to high quality and on-time deliverables are key success factors

Microsoft Office Suite

Ability to perform Literature searches for specific research questions and collate published literature in a succinct manner

Preferred

5+ years of experience in applied (clinical or discovery) research with a focus on pulmonary diseases

5+ years of experience in specialization in cardiopulmonary disease, such as, PH, COPD, IPF, CF, etc

Experience in making presentations to a wide audience on research conducted and authoring manuscripts

Experience in drug development for orphan diseases

Experience in Clinical development of Pulmonary diseases

Experience with creating and querying databases as assigned

Clinical research/development/specialty in cardio-pulmonary disease, such as, PH, COPD, IPF, CF, etc

Benefits

Medical / dental / vision / prescription coverage

Employee wellness resources

Savings plans (401k and ESPP)

Paid time off & paid parental leave benefits

Disability benefits

Company

United Therapeutics Corporation

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Founded to find a cure for a daughter’s rare disease, United Therapeutics is a biotechnology company transforming care for people with chronic and life-threatening conditions.

Founded in 1996

Silver Spring, Maryland, USA

1001-5000 employees