[Close] 

Director Clinical Development CNS/Psych.

Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma.?Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.


Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective?therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. ?Power your future & join our bold team.

Position Overview

The Director is responsible for providing clinical development direction and guidance at the project and study level in support of studies within the CNS/Psychiatry therapeutic and may perform different roles depending on the scope of the assigned projects and the needs of the organization.

As the Clinical Science Lead and/or the Clinical Scientist, s/he is a member of the Clinical sub-team and has responsibility for providing scientific and clinical development guidance and expertise at the clinical sub-team and study level.

The Director assists in the preparation for and may represent R&D at regulatory agency meetings, symposia and trade associations and aims to establish and maintain a strong network within the Pharmaceutical industry.

The Director is expected to be fully capable of performing all the roles encompassed in the preceding grade levels within the job family as required by the organization. Other activities, special projects and assignments may be given as necessary. As a result, the percentage of time spent across the roles for which the employee is responsible or accountable will vary depending on project assignments, current development projects and the requirements within the organization as a whole.

The Director must conduct his/her work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all Allergan policies, and procedures. Allergan policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

Main Areas of Responsibilities


????????The Director is an internal scientific expert in the disease area and scientific aspects of the competitive landscape and is accountable for ensuring the medical/scientific expertise, validity and integrity of the clinical development program and study protocols, clinical study reports and clinical and regulatory documents.


?????????Depending on the role, s/he leads or supports clinical study planning and execution through the development starting with the creation of the Clinical Development Plan (CDP) and clinical study protocol synopsis, input into the clinical study protocol and Clinical Study Report and Clinical sections of the CTD for regulatory submissions, while working collaboratively with the cross-functional Clinical Team to assess study data, integrate summaries of safety and efficacy, risk / benefit assessments, etc. This information is incorporated into Agency briefing packages, Investigator Brochures, and regulatory documents, including the clinical modules for submissions.


?????????In addition, the Director is a key contact for relationships to external experts / key opinion leaders and provides regular scientific-medical disease state updates, etc.


?????????The Director will work collaboratively with the Clinical Subteam Lead to ensure the development and execution of the clinical strategy. This includes the clinical team?s creation of relevant documents and outputs including Clinical Development Plan (CDP), clinical program feasibility, investigator?s brochure, study protocol synopsis, clinical study protocols, top line study data communication plan, Clinical Study Report (CSR), clinical sections of regulatory documents including the clinical sections of the CTD for regulatory submissions, and planning of the Annual reports together with Regulatory affairs and respective clinical team members. S/he ensures alignment of the CDP with the Global Development Strategy (GDS). In addition, working collaboratively with the Clinical Subteam Lead, the Director may monitor activities related to the Clinical development program, including achievement of key program milestones within the planned time lines and budget.


?????????The Director may also serve as a Submission team leader or co-leader for regulatory submissions.


???????? In collaboration with the core project team members and the departments involved, the Director leads the synthesis of the project development strategy, contingency plans, tactics, budgets, timelines, milestones and submission targets into the Global Development Plan (GDP).


?????????The Director is responsible for adherence to all relevant regulations eg: ICH, PhRMA and CFR guidelines, as well as Allergan?s policies, SOPs and Work Instructions. Ongoing training in compliance areas and therapeutic specific knowledge is expected in order to maintain a solid knowledge base for performing assigned tasks. Support and oversight of epidemiological studies as needed. May provide strategic and/or technical consultations on behalf of the therapeutic area (e.g., study design, business development, marketing, communications, training, legal, etc.).

?


Requirements


?????????5+ years relevant clinical/drug development experience including experience of working in clinical research with a strong understanding of the clinical and global drug development process.


?????????3+ years? experience as a cross-functional team leader preferred


?????????Ability to travel up to 30% of time


Preferred Skills/Qualifications


?????????Therapeutic Area experience in CNS, Pain/Migraine, Psychological Disorders a plus.

?


Additional Skills:


?????????Takes initiative to contribute ideas and knowledge to team globally


?????????Participates in team activities


?????????Uses facts and data to validate own position


?????????Actively seeks to understand other perspectives


?????????Articulates business impact


?????????Matches communication to audience


?????????Builds consensus


?????????Communicates effectively with internal/external stakeholders


?????????Encourages ideas from others


?????????Explains complex issues


?????????Actively influences others without a direct reporting relationship


?????????Strategic Thinking


?????????Make connections between organization, team, product, ideas, etc.


?????????Demonstrates some understanding of implications of strategic decisions


?????????Seeks more knowledge of industry, competitors


?????????Execution and Accountability


?????????Identifies and resolves complex problems


?????????Delegates to team and keeps them focused


?????????Identifies and implements best practices


?????????Identifies and drives priorities


?????????Takes charge of removing obstacles to project


?????????Evaluates resource needs


?????????Creates and communicates solutions for unpopular business needs


?????????Meets corporate timelines


?????????Global Mind Set


?????????Demonstrates basic understanding of global environment


?????????Build relationships with global colleagues


?????????Demonstrates understanding and respect for cultural differences and needs


?????????Inclusive in interaction with others


?????????Embraces diversity of thoughts, ideas, and approaches

?

Education


?????????MD, PhD or PharmD is?required.

LI-DM1


 

Don't Be Fooled

The fraudster will send a check to the victim who has accepted a job. The check can be for multiple reasons such as signing bonus, supplies, etc. The victim will be instructed to deposit the check and use the money for any of these reasons and then instructed to send the remaining funds to the fraudster. The check will bounce and the victim is left responsible.

More Jobs

Medical Director, Clinical Development
Florham Park, NJ Shionogi
Dir, Clinical Development Psychiatry
Madison, NJ Allergan
Director, Clinical Safety (MD)
Basking Ridge, NJ Daiichi Sankyo, Inc.
Clinical Access Coordinator, Psych ER, Per Diem
Jersey City, NJ Christ Hospital
Clinical Coordinator - SCBNJ Psych Acute Adult...
Boonton, NJ Prime Healthcare Systems