Posted to MedZilla on 10/29/2017


Barrington James

US-NY, Senior Manager/ Associate Director Clinical Development KBM12594-MZ


 
 

Seeking an exciting leadership position in the clinical arena? Looking to truly impact clinical development? I have a wonderful opportunity for a Senior Manager/Associate Director of Clinical Development within a rapidly developing therapeutics organization with a candidate like you in mind.

The current role requires a dynamic, motivated and experienced individual and offers a competitive salary with an impressive benefits package.

Location: NYC

Major Responsibilities:

· Oversees direction of clinical development strategies and processes for projects based on the highest scientific, medical, and regulatory standards

· Accountability and ownership of clinical development plans, clinical concept sheets and protocols, confidential information brochures, data analysis plans, clinical study reports, and clinical sections of regulatory submissions (IND, CTA, and CTD)

· Initiation and development of strong scientific and medical relationships with consultants, industry leaders, and clinical investigators with particular focus on relationship building and understanding unmet medical needs

· Continuous interpretation of clinical safety and efficacy results for strategic and regulatory and pharmacovigilance purposes

· Provides scientific and medical input to support Business Development (BD) functions in the identification of potential partners

· Attracts, assesses, selects and develops highly competent, experienced clinical personnel

· Setting of clear, focused, challenging targets to accomplish significant business objectives consistent with departmental goals

· Shares clinical experience and expertise with colleagues in various functional areas such as Manufacturing, Quality, Regulatory Affairs, R&D, Legal, and BD

· Knowledge of and compliance with global GCP/ICH guidelines

· Contributes to the development of the company's overall infrastructure and growth strategies

Requirements and Qualifications:

· Advanced degree highly preferred (MD, PhD) ideally with specialty training however BS/MS/RN will be considered commensurate with experience

· Knowledge of stem cell, metabolic, endocrinology (diabetes) and respiratory (asthma) clinical development

· Demonstrated knowledge of GCP/ICH rules and regulations.

· Exceptional leadership skills, strategic guidance and good judgment in handling complex situations

· Professionalism, maturity, confidence, and credibility combined strong business acumen and impeccable integrity

· Remarkable organizational, time management, interpersonal, and conflict resolution skills

· Decisive and able to successfully manage multiple projects simultaneously

· Excellent interpersonal skills; strong in providing education on complex scientific/clinical issues in a crisp and clear manner both to peers and larger audiences

For more information on the exciting opportunity, please contact Kevin Burns

+1 (919) 838-7478

[click here]


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