Clinical Development Director

R&D Malvern, Pennsylvania


Description

Job Summary - a concise overview of the job

The Clinical Development Director will be the clinical development lead for one or more projects, and will assist in the planning, implementation, managing, and reporting of clinical trials. The incumbent will work with the internal cross-functional R&D team and/or CRO to prepare and review clinical trial synopses and protocols, Investigator Brochures, and clinical study reports; review SAPs and TLF shells; evaluate emerging clinical trial data; assist with data interpretation and data mining; ensure that assigned studies are conducted according to GCPs and Departmental SOPs; assist in conducting literature searches and reviews, meta-analyses, and publishing data; contribute to the preparation of IND/NDA medical sections; support business development activities by evaluating new product potential; and assist in the review of clinical study entries (clinical trial information and results) for posting to www.clinicaltrials.gov (clinical trial registry and results database) and/or a TPR (Third Party Registry).  The incumbent will have primary responsibility for providing clinical development input to the Brand teams.

 

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

 

 

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Clinical Trials Management

Lead the planning, implementation, managing, and reporting of clinical trials and programs in adults and children:

§  Prepare, review, and approve clinical trial synopses and protocols, Investigator Brochures, and clinical study reports

§  Review SAPs and tables, LTF shells

§  Assist with data interpretation and data mining

§  Ensure that assigned studies are conducted according to GCPs and Departmental SOPs

§  Assist in conducting literature searches/reviews, meta-analyses, and publishing data

§  Contribute to the preparation of IND/NDA medical sections.

§  Work closely with internal team and CRO in execution of trials, and provide ongoing guidance to CRO for protocol-specific clinical issues, site problems, and recruitment strategies. 

§  Develop Clinical Development Plan (CDP), including budget and timelines. 

80%

Business Development

Function as the Clinical Lead for business development activities by evaluating new product potential

5%

Clinical Trial Posting

Review/approve of clinical study entries (clinical trial information and results) for posting to www.clinicaltrials.gov and/or TPRs.

5%

Stakeholder Management

Provide medical/scientific input to Brand teams

5%

Clinical Study Publication

Lead the creation, review and approval of abstracts, posters and manuscripts for clinical studies in support of the publication strategies for assigned brands

5%

 

 

 

Total

100%

 

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and  certifications required for the job

Advanced scientific degree (MD, DVM, Dr.P.H., Pharm.D., Ph.D., Sc.D.)

 

§  Experience in pharmaceutical research, specifically exposure to the IND/NDA approval process and Phase I, II, III and IV clinical research.

§  The incumbent should have at least 12+ years of directly related pharmaceutical clinical research experience.

§  The incumbent must have demonstrated experience in clinical research, study trial management, clinical database maintenance, generation of research hypotheses, and publication and presentation of scientific information.

§  Professionalism, objectiveness, critical thinking, evidence-based reasoning, and a positive outlook are of the utmost importance


Knowledge

Proficiency in a body of information required for the job    

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

§  The position requires research administration experience, knowledge of scientific principles of controlled trials, and a comprehensive knowledge of FDA and ICH guidelines.

§  This position also requires a working knowledge of software packages (e.g., MS Word, MS Excel, MS PowerPoint).

Skills

&

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.

§  The abilities to work on a team, cooperate with colleagues, and effectively communicate with a diverse audience, at multiple levels, both inside and outside the company, are essential.

§  A capability to work with cross-functional teams at the protocol and clinical program level is mandatory.

§  Excellent human relations and communication (written and oral) skills are required.

§  Effectively resolves conflicts between individual needs and requirements of the organization

§  Demonstrates the ability to analyze complex situations and proactively identify opportunities/issues; effectively solves problems that cross functional boundaries

Physical Requirements

Physical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

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Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.