Director/ Sr. Director Clinical Research

Lawrence Harvey

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Job ID :

7055


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Medical Doctor


Address 1 :

North America,--Massachusetts,Boston,


Key Skills :

Clinical Research Immunology Rheumatology Gastrointestinal GI


Salary :

Negotiable


Date Posted :

04 May, 2017



Company Name :

Lawrence Harvey


Location1 :

Boston




Job Category :

Clinical Research Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

upto 15%





Description

Director/ Sr. Director Clinical Research (MD Qualified)

Greater Boston Area

SciPro Global are currently seeking a highly motivated and experienced pharmaceutical physician interested in joining one of our key clients based on the East Coast. The primary responsibility of the Director of Clinical Research will be to provide medical expertise and leadership necessary to advance one or more of the Company's lead drug candidates through Phase I- III of their clinical trials. The Senior Director/ Director, Clinical Research, will drive the design, planning, and implementation of clinical program/s and study protocols for drugs that are in all phases of development, and will play a key role in supporting related regulatory activities. This clinical development expert will also support attainment of corporate strategic objectives by contributing their clinical, scientific and development expertise to business development initiatives, co-development partnerships, and development plans for pre-clinical programs.


Role & Responsibilities:

* Lead the creation of clinical strategies and development plans for assigned programs in Phase I, II, or III of development, in consultation with cross-functional team members and outside consultants, to meet all requirements of the product development strategy
* Be the recognized clinical expert for these development program/s both within and external to the client
* Provide medical input into the design of clinical trials for these development programs
* Serve as a medical monitor for clinical studies (provide medical oversight of the study; answer questions about eligibility; review safety and adverse event information), working closely with cross-functional team members to ensure planning and execution of clinical trials to meet key milestones, maintain timelines and keep within agreed budget
* Assist in the preparation of clinical protocols and FDA/EMA documents (eg., INDs, annual reports, meeting requests, briefing books, and NDAs) and other relevant clinical documents
* Provide authoritative clinical leadership in preparation for and interactions with Regulatory Authorities
* Play a key role in the development of analysis plans, and in the review, interpretation and communication of clinical trial data from Phase I to III safety and efficacy trials; assist in generating the study reports and publications from these trials
* Establish strong Scientific Advisory Groups of external thought leaders to support the development of compelling clinical development strategies and help optimize program plans and protocols
* Collaborate with other members of the Clinical Affairs and broader R&D teams on medical matters related to drug development
* Support pre-clinical development planning and translational medicine efforts to effectively advance pipeline programs
* Provide clinical, scientific and development expertise to business development initiatives as needed



Requirements:

* An MD or DO degree
* Medical expertise in internal medicine (specialty training and board certification would be ideal, but is not required)
* Six or more years of pharmaceutical/biotech-industry experience in clinical research and development
* Possesses thorough understanding of strategic and operational aspects of clinical research and product development
* Strong general knowledge of regulatory requirements such as apply to clinical drug development, with significant experience interacting directly with Health Authorities
* Excellent ability to lead and work in cross-functional teams with a collaborative style that builds alliances and emphasizes integrity, results, collegiality and effective teamwork in a fast-paced and changing environment
* Persuasive, effective and flexible in personal interactions at all levels, with strong oral and written communication capabilities


Company Name:

Lawrence Harvey


Headquarters:

150 Leadenhall Street,London


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

EC3V4TE


Website:

www.lawrenceharvey.com


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


City:

London


Phone No. :

0203 327 3072


Lawrence Harvey Life Sciences has exceptional relationships with the top talent and leading organisations in the Pharmaceutical and Medical Devices industry across the UK, USA, DACH region and the rest of Europe. Our consultants are experts within their specific areas and have a deep understanding of the full Life Sciences developmental cycle. As a client with a challenging role or a candidate with a niche specialism, you will receive a consultative service from people who truly understand the expectations and requirements of your industry. In an ever developing industry, an in-depth technical understanding and knowledge adds significant value and is imperative to ensuring our consultants are always up to speed, positioning ourselves perfectly to offer advice, analysis and support to our clients and candidates. We partner with leading pharmaceutical, medical device, generics, biotechnology, clinical research, R&D, manufacturing, regulatory affairs, CRO’s, CMO’s and medical communications organisations and have acquired an enviable and unrivalled reputation for delivering on niche, hard to fill and challenging positions. Our Specialisms within Life Sciences: Pharmaceuticals Medical Devices Regulatory Affairs Quality Assurance Quality Control Engineering Medical Affairs / Medical Information Qualified Persons Drug safety & Pharmacovigilance Biostatistics Clinical SAS Medical Writing Account Management & Business Development

For more information,visit www.lawrenceharvey.com.

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