Head of Clinical Affairs

Piscataway, NJ

Contract

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Head of Clinical Affairs in Piscataway, New Jersey. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.

RESPONSIBILITIES

  • Develop a clinical and scientific evidence strategy and successfully execute a tactical plan to support client’s business
  • Focus will be on studies that support clinical claims and those that are necessary to prove efficacy and value of client’s technology to clinicians while maintaining unwavering commitment to patient safety and clinical accuracy
  • Coordinate all aspects of clinical operations including: design, initiation, coordination of clinical and scientific studies to support regulatory submissions, as well as post-market clinical trials. In case of CRO managed studies: Lead CRO evaluation and selection process, and provide ongoing CRO oversight
  • Coordinate the preparation of study documentation, including: protocol, statistical data analysis plan, monitoring plan, informed consent form, case report forms, investigator agreement and financial disclosure agreement, as require
  • Responsible for clinical-comparison aspects of biosimilar product development
  • Responsible for conduct on clinical trials by designing the programs, monitoring them for safety, reporting adverse events, and (with Regulatory Affairs) providing documentation to regulatory agencies
  • Ensure compliance with all applicable regulatory standards related to clinical trials and interactions with physicians
  • Identify and pursue relevant grant opportunities to support the scientific and clinical applications of TPI products
  • Interface with other functional leaders including Regulatory, Quality, and Operations to ensure that clinical activities are in line with overall strategic goals
  • Remain up-to-date and familiar with all relevant literature and industry trends and serve as a clinical reference and educator for internal personnel. Notify marketing and sales teams promptly on impact of new publications and emerging technologies as it happens
  • Provide input to Quality personnel during complaint and quality investigations
  • Review and advise on new technology/product ideas; on pre-clinical testing and clinical research protocols; provides opinion on new products
  • Provide input on both the design and content of marketing materials
  • Collaborate with the legal team to ensure the accuracy of all documentation
  • Represent the company at conferences and other events
  • Respond to customer complaints or questions
  • Support training to physicians using the company’s product
  • Assist in the establishment of advisory boards and physician review groups, participating when appropriate
  • Provides medical input on claims management, investigations, and other matters demanding medical expertise
  • Oversee development and execution of professional education programs in terms of key objectives, content, participant selection and administration
  • Ensures compliance with regulatory standards regarding clinical affairs, engagement with physicians and researchers, and industry’s involvement with clinical affairs. Regulatory standards (including FDA, EMEA and CDSCO), and the American Medical Association (AMA) and HIPAA
  • Manage external clinical resources to support the Company’s growing needs
  • Serve as technical resource to network of external experts and KOLs that can provide advice for clinical activities across therapeutic areas, including cardiovascular, heart failure, emergency medicine, dialysis, patient monitoring. Develop a strong, personal “go to” network of health care professionals that can advise on product, technical and clinical issues
  • Foster a passion about the value of TPI’s vision for helping patients & delivering high quality, effective technologies
  • Liaison between staff and senior management or the company and the public on clinical topics
  • Establish goals for specific projects and offer guidance

EXPERIENCE

  • Minimum seven years’ experience direct industry experience in a clinical leadership role in a commercial-stage medical device or digital health company with FDA regulated products is essential
  • Must be licensed to practice medicine in their state / region / country
  • Expertise in design and development of scientific research protocols, clinical investigational plans, and regulatory strategies
  • Thorough knowledge of FDA EMEA and CDSCO guidelines and local regulations concerning clinical research, as well as ICH Good Clinical Practices (ICH-GCP) governing the conduct of clinical trials
  • Hands-on experience in the design of protocols pre-clinical and clinical study work

EDUCATION

  • At least a graduate degree in a life science such as biology, a doctor of medicine (M.D.) and possibly a master of business administration (MBA) or a master of health care administration (MHA)

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately

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