Executive Director, Head of Global Clinical Development

Summary

This position reports to the VP, COO. The Executive Director, Head of Global Clinical Development oversees all clinical trials and provides the overall leadership regarding the scientific and clinical strategy for the portfolio and is accountable for meeting all clinical objectives for the department.

Education and Credentials

• MD, PhD, or PharmD.

• Specialty therapeutic credentials in a relevant therapeutic domain is desired.

Experience

• At least 12 years in all phases of clinical development gained working for pharmaceutical,

biotechnology, or CRO company.

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.

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