Clinical Affairs Contractor

US-NJ-Piscataway
3 weeks ago
ID
2017-1975
Adello Biologics, LLC

Overview

Adello Biologics is a privately held, U.S.-based biotechnology company that leads with science to accelerate development and drive manufacturing efficiency. The company's aim is to provide high-quality, affordable biosimilars to patients worldwide. Headquartered in Piscataway, NJ and driven by a team of highly skilled industry veterans, Adello is advancing a strategic pipeline of proteins and complex monoclonal antibodies with lead candidates in oncology and immunology. For more information, visit www.Adellobio.com

 

Our vision is to make biosimilar medications affordable. We are seeking candidates interested in contributing to a bourgeoning field that has the potential to help millions of patients. As a growing company, Adello Biologics offers real development opportunities for candidates excited to take on responsibility, make an immediate impact and help us achieve our vision. As part of a close knit team, you’ll have the opportunity to work in a unique, high science industry while expanding your career. We are seeking a Clinical Affairs Contractor to be based out of our HQ in Piscataway, NJ.

 

Responsibilities

The Clinical Affairs Contractor is responsible for all aspects of the clinical strategy, development of a comprehensive scientific and clinical evidence plan in support of Adello’s business. He/she will be a representative of the Company to the clinical community and must have the ability to represent the Company, its science and its products professionally, passionately and credibly.

 

Essential Duties and Responsibilities:

  • Develop a clinical and scientific evidence strategy and successfully execute a tactical plan to support Adello’s business. Focus will be on studies that support clinical claims and those that are necessary to prove efficacy and value of Adello’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 required.
  • 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

Qualifications

PREREQUISITES:

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)
  • Must be licensed to practice medicine in their state / region / country
  • If they work within a specific therapeutic area they must hold board certification in that specialty

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.

 

SPECIALIZED KNOWLEDGE AND SKILLS:

  • Strong communication and presentation skills with the ability to communicate to complex concepts and ideas to diverse audiences including health care professionals at all levels, researchers, investors and business partners and internal TPI personnel.
  • Ability to develop, articulate and execute short and long term clinical strategies.
  • 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.
  • Energetic, out-of-the-box thinker with a passion for delivering new and clinically advantageous technologies to the healthcare market

 

WORK ENVIRONMENT AND PHYSICAL DEMANDS:

General Work Environment:

  • Standard office environment.

Noise:

  • Standard office setting noise levels.

 

Standing/Lifting:

  • Must be able to lift 15 lbs.

 

Visual:

  • No special requirements.

 

Stress:

  • High paced demanding environment to meet ambitious project goals.

 

 

Travel:                                                       

  • Ability to travel as required: vendors, clinical sites, clients, conferences

 

Adello Biologics, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Adello Biologics, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.

 

Notice To Agency And Search Firm Representatives

Adello Biologics is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Adello employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Adello. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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