CRP Lead

Summary
This position reports to the VP, Clinical Science. The Clinical Research Physician works with the VP, Clinical Science, to provide the overall leadership regarding the scientific and clinical strategy for primarily the company's insulin assets and is accountable for meeting all clinical objectives for the program.

Education and Credentials
• MD, PhD, or PharmD.
• Specialty therapeutic credentials in a relevant therapeutic domain is desired.

Experience
• At least 10 years in all phases of clinical development gained working for pharmaceutical,
biotechnology, or CRO company.
• Experiences in Metabolism and Endocrinology (such as diabetes, obesity, NASH, CKD), insulin/GLP-1 is a plus.

Skills
• Strong ability to create, and then lead, successful asset development teams.
• Adept at managing challenging programs in a complex and rapidly changing environment.
• Ability to think strategically to create solutions for difficult and complex problems.
• Highly effective interpersonal skills, in individual as well as in group settings.
• Demonstrated ability to lead people in a positive manner.
• Demonstrated ability to manage multiple and diverse projects concurrently.
• Demonstrated ability to develop positive relationships and collaborations.
• Able to represent the Company in a variety of internal and external settings.
• Persuasive, effective, and flexible in personal interactions at all levels of the organization, particularly
with other vice presidents and senior leaders.
• Strong analytical skills; a strategic thinker, planner, and implementer.
• Solid medical/scientific skills with relevant clinical and therapeutic understanding.
• Working knowledge of statistics, data analysis and data interpretation.
• Deep experience with literature analysis, designing and writing of clinical protocols, clinical reports, clinical development plans, CRFs, reviewing and evaluating clinical data, preparing INDs, NDAs, BLAs.
• Experience with the operational aspects of clinical trials and related activities such as investigator meetings, DSMB’s, and GCP/ICH.
• Excellent written and oral communication skills and a command of the English language.
• Strong proficiency in major Microsoft Office products (i.e., Word, Excel, PowerPoint, Project).
• Enthusiastic, genuine, ethical, fair, and loyal to the organization and its vision and goals.

Responsibilities
• Oversee the design, execution, and reporting of clinical trials that meet the standards of excellence for ethics, scientific merit, and regulatory compliance, as well as satisfy corporate goals for approval of products.
• Provides medical and scientific input to the core documents for the project (e.g., product strategy documents, target product profile (TPP), protocols, submission, etc.).
• In partnership with regulatory leadership, oversee the preparation of worldwide regulatory submissions.
• Oversees the dissemination of company clinical data through publications, conference presentations symposia, etc.
• Oversees clinical consultants and collaborators in the clinical research program.
• Contribute scientific and clinical development expertise in asset portfolio management activities of the organization.
• Establish productive, interactive relationships between the clinical group and other key company departments, as well as with outside medical and scientific communities.
• Represent the Company as needed as a senior clinical spokesperson to a variety of scientific, and business and government groups/agencies.
• Serves as key clinical research representative at strategic meetings/advisory boards.
• Consults with internal/external stakeholders and internal/external key opinion leaders.
• Serves as a medical or scientific representative with investigators and regulatory authorities.
• Provides broad support to clinical operational teams.
• Provides medical and scientific interpretation of efficacy and safety data.
• Plays a key role in the interactions with regulatory authorities (e.g., FDA, EMEA meetings). This includes developing key documents, participating in the preparation for meetings with the health authorities, and participating in the meetings and interactions with the health authorities. Serves as the main scientific/clinical representative during these interactions.
• Provides input for a project publication plan, liaises with commercial, and works on launch activities when required.
• Creates and reviews abstracts and manuscripts created by internal or external sources.