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Hologic Director, Clinical Affairs - GYN Surgical Solutions in Marlborough, Massachusetts

Duties & Responsibilities

  • Primary cross-functional leader responsible for Division clinical activity required to secure and maintain regulatory approvals in the US, EU and abroad

  • Strategically identify and define relevant clinical questions in a cross-functional environment

  • Manage an interdisciplinary team of applied scientists in identifying, designing, initiating, and managing necessary internal and external clinical research initiatives to drive evidence generation, publication and dissemination across Division product lines to achieve and maintain regulatory clearance in the US and abroad, promote clinical acceptance and secure payer and society guidelines to drive product adoption

  • Develop and cultivate Hologic’s scientific partnerships with U.S. and International external experts, academic institutions, professional societies, cooperative groups and their foundations, large multi-center research organizations and other relevant external parties to support new application development (e.g. poster development, white papers, presentations, clinical evidence, market and clinical evaluations.)

  • Present complex aspects of independent and investigator-initiated protocol design to key stakeholders, highlighting the key risks and benefits for proposed studies in support of IFU modifications

  • Excel in talent management. Attract, hire, and develop talent and leadership capability in direct and dotted-line reports. Manage succession planning and employee development to ensure a strong talent pipeline. Lead by example through objective setting, performance management, regular communication and feedback, staff development, and appropriate rewards/recognition.

  • Support future product ideation by identifying technologic, imaging and workflow solutions that can realistically achieved within necessary timeframes, including participating in landscape assessment and technical feasibility exercises

  • Aid in the development of proactive intellectual property strategies to protect future product development via risk mitigation, and assist in regular IP review and documentation processes

  • Participate in systematic literature reviews with Medical Education aimed at collecting tier I-III evidence in support of company products

  • Provide scientific guidance in the critical appraisal of literature supporting competitor products to maintain competitive attractiveness

  • Participate in competitive intelligence activities aimed at remaining current with ongoing trials and studies evaluating company and/or competitor products

  • Serve as an internal scientific and clinical thought leader for internal teams, such as Marketing, R&D, Clinical Affairs, Legal, Health Economics, Quality and Regulatory

  • Serve externally as an acknowledged expert on company’s products and related competitive products in all topics relevant to external customers, specifically: clinical, scientific, technical and health outcomes and economics research

  • Drive for outstanding results incorporating a sense of urgency when pursuing goals

  • Demonstrate ability to think strategically, set and manage priorities, manage multiple projects and allocate and reallocate resources as required

  • Work collaboratively across functional areas to achieve common goals

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required.

  • Clinical and/or research experience

  • Strong and proven problem-solving capabilities

  • Knowledge and understanding of medical and clinical terminology, clinical workflow, and biostatistics analysis and software (STATA, SAS, and/or R)

  • Understanding of regulatory issues in the medical device space

  • Excellent oral and written communications skills as well as presentation skills and the ability to effectively communicate Hologic’s position to various stakeholders to achieve operational alignment

  • Experience in developing and managing academic-industrial partnerships

  • Proven strong interpersonal skills and ability to succeed in a matrixed environment

  • Attention to detail and ability to meet deadlines

  • Strong organizational skills with the ability to multi-task and adjust to changing priorities

Education

  • Advanced degree in a scientific or quantitative field

  • Experience in the healthcare industry required

Experience

  • 7+ years of experience in working with healthcare/medical professionals in either academic or industry including:

  • At least 3 years of management experience leading others

  • Experience leading a pivotal trial

Agency and Third Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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