Executive Director, Clinical Affairs

Location: Bedford, MA | Remote

Summary of Primary Responsibilities:

The Executive Director, Clinical Affairs is responsible for defining the strategy to obtain clinical evidence to obtain registrations for new products, expanded indications, and expansion into new geographical territories.  The Executive Director, Clinical Affairs has the overall responsibility for the design and successful execution of all Anika clinical studies to demonstrate product safety and efficacy. The Executive Director, Clinical Affairs is responsible for ensuring that trials are conducted in full compliance to GCP and all other applicable regulatory requirements. The Executive Director, Clinical Affairs manages the Anika Clinical Organization. 

Specific Responsibilities:

  • Assist in the strategic translation of business objectives into clinical requirements for clinical trials and investigator-sponsored studies to obtain pre-market approval or for post-market regulatory requirements for clinical evaluations and post-market surveillance.
  • Manage the Clinical Organization, including hiring and development of clinical personnel.
  • Develop clinical study designs by researching disease state, target patient population, indications for use, standard of care from medical association guidelines, and other scientific literature.  Ensure a clinical study design will address the safety, performance and efficacy requirements of the Anika product.
  • Develop timelines and budgets for clinical research activities.  Oversee drafting of clinical study documentation.
  • Oversee the process of screening, qualifying, and selecting, and contracting with investigators, sites, CROs, and other vendors required for conduct of clinical trials.
  • Work with team to obtain necessary clinical trial approvals from IRBs/EC’s and regulatory bodies such as the FDA, Health Canada, and Competent Authorities.
  • Ensure studies are on track for site initiation, patient recruitment and enrollment, and take corrective actions where necessary to address issues.
  • Oversee statistical analysis of clinical studies and the drafting of Clinical Study Reports. Work with investigators to publish results of clinical studies.
  • Ensure adherence to protocols and compliance with regulatory (FDA/ICH/GCP) guidelines as well as SOP procedures.
  • Manage the financial aspects of clinical studies and adhere to company financial goals and established budgets.

Job Complexity:

The Executive Director, Clinical Affairs will translate business commercial objectives into requirements for specific clinical trials and programs.  This role is responsible for the execution of Anika clinical trials as well as the management, growth, and development of members of the clinical organization.  The position requires maintenance of up to date knowledge of all applicable international regulation and regulatory guidance, as well as in-depth product knowledge and clinical / medical knowledge of indications. The position requires the individual to have strong leadership, problem-solving, and decision-making abilities.

Supervisory Responsibilities:

Responsible for managing internal clinical resources (Clinical Project Managers, Clinical Research Associates, and Clinical Coordinators) and external resources including sites, investigators, CROs, and other vendors.

Experience, Knowledge, and Skills Required:

  • BS, BA, or higher degree in the Life Sciences or related disciplines.
  • Minimum 8 years in senior clinical management position in biopharmaceutical or device industry, CRO or academic/hospital clinical research environment.
  • Additional 8+ years direct experience in clinical trial management, with a minimum of 3 years at the Director level.
  • Solid track record in successfully executing Phase I – IV clinical trials.
  • Demonstrated expert knowledge and comprehensive understanding of applicable GCP, ICH guidelines & FDA and applicable international regulations.
  • Strong, hands-on manager with experience in managing clinical affairs staff and CROs, Core Labs, Data Management, Biostatistics, and Medical Affairs Safety Reporting.
  • Knowledge of electronic data capture systems and web-based clinical trial management tools.
  • Excellent interpersonal, written / verbal communication & organizational skills.
  • Collaborative team player.
  • Strong program management and financial skills
  • High level computer skills required (e.g. MS Word, Excel, PowerPoint).
  • Willing & able to travel domestically and internationally, as required (up to 30%)

We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.