Clinical Affairs Manager

Company Overview

 

Anika Therapeutics, Inc. develops, manufactures and commercializes therapeutic products for tissue protection, healing and repair.  These products are based on hyaluronic acid (HA), a naturally occurring, biocompatible polymer found throughout the body. HA enhances joint function and coats, protects, cushions and lubricates soft tissues.  HA is also present in the skin, where it supports skin structure and elasticity.  Anika’s current commercial product lines address the joint health, aesthetic dermatology, ophthalmic and anti-adhesion markets.  A public company since 1993, Anika is headquartered in Bedford, Massachusetts.

 

 

Position Summary:

 

Clinical Affairs Manager will assume operational management responsibility for planning, design, implementation and execution of clinical programs as well as interpretation of clinical study results, preparation of study summaries and reports for regulatory filings, presentations and publications. This position is reporting to VP of Regulatory and Clinical Affairs and will be a main supporter and contributor to the effort to establish sound clinical data in support of product development and commercialization objectives. This position will assume responsibility for the design and implementation of clinical trials to demonstrate medical product safety and efficacy.





Specific Responsibilities:

 

· Provide operational perspective to planning of clinical studies. Develop and review clinical study protocols and obtain IRB approvals, as necessary

· Establish timeline and cost estimates for clinical studies.  Manage budget for Clinical Affairs resources and the conduct of clinical studies.

· Overseeing clinical studies as necessary. Participate in site selection and qualification. Monitoring clinical sites, as needed, including pre-investigational site visits, initiation visits, interim visits and study closeout visits.  Conduct site and vendor (CRO and central lab) audits.

· Plan, monitor and report patient enrollment and implement corrective actions as necessary to meet enrollment targets.

· Manage contractual negotiations for all clinical studies involving outside parties. Prepare clinical study agreements to gain approval for standard and non-standard contract language.

· Act as the key interface with Clinical Research Organizations (CROs).

· Coordinate all GCP activities from site selection through data completion and regulatory site audits with CROs.

· Lead the preparation of clinical documents for regulatory submissions.

· Coordinate generation and assembly of all documentation associated with clinical studies, such as protocols, case report forms, informed consent documents, investigator agreements, investigator brochures. Prepare and track required documentation from clinical sites.

· Generate documented timelines for initiation to completion and reporting of clinical studies

· Conduct reviews of published literature or clinical and preclinical reports in the field to provide the context for clinical development programs

· Manage negotiation with Contract Research Organizations (CRO) as needed. Negotiate investigator and CRO budgets in collaboration with Finance Department.

· Ensure budgets, schedules, and performance requirements are met.

· Ensure adherence to protocols and compliance with regulatory / FDA / ICH  / GCP guidelines as well as SOP procedures.

· Develop SOPs and guidelines to assure internal files, site files and field data conform to Good Clinical Practice regulations and standards as well as applicable sections of 21 CFR

· Identify clinical training needs and develop training materials for in-house and clinical site use

· Develop, maintain and expand collaborations with outside clinical investigators, researchers and consultants to facilitate the optimum performance of clinical development programs

· Coordinate production, labeling and delivery of clinical supplies with Operations, external labeling company, and investigational sites.

· 20% - 40% travel required, dependent on number of on-going projects

· Coordinate with distributors on supervision of non-company-sponsored international clinical trials.

· Ensure appropriate regulatory agency approval of changes in investigational plans.

· Maintain the portfolio of clinical studies, providing periodic evaluation and problem identification and resolution, as necessary

 

 

Supervisory Responsibilities:

 

Supervises activities of external Contract Research Organizations and investigational sites.



 

Experience, Knowledge, and Skills Required:

 

· BS or higher degree in the Life Sciences or related discipline.

· Minimum 5 years in biopharmaceutical or device industry, CRO or academic/hospital clinical research environment.

· 5+ years clinical monitoring experience. Required to have direct clinical research experience and to have supervised clinical studies as a project leader

· Solid experience leading the management of clinical trials (Phases I-III).

· Must have demonstrated experience & skills in getting clinical trials up and running and off the ground.

· Successful track record working with and/or managing CROs.

· Demonstrated expert knowledge and comprehensive understanding of applicable GCP, ICH guidelines & FDA and applicable international regulations.

· Knowledge of electronic data capture systems and web-based clinical trial management tools

· Working understanding of biostatistics;

· Ability to contribute at multiple levels, ranging from management level to hands-on.

· Excellent interpersonal, written / verbal communication,  & organizational skills and ability to juggle assignments without losing efficiency; employs tactfulness & diplomacy in dealing with study coordinators and physicians.

· Computer literacy is required (e.g. MS Word, Excel, PowerPoint).

· Willing & able to travel domestically and internationally, as required (up to 40%)

· Requires project management and negotiation skills in a team environment.

 

 

Please apply online at http://www.anikatherapeutics.com or email your resume to Recruiter@anikatherapeutics.com  

 

Anika Therapeutics, Inc. thanks all applicants for their interest, but advises that only those candidates considered will be contacted.  Unsolicited resumes from agencies not approved to work on this particular opening becomes the property of Anika Therapeutics, Inc..