MSL/Sr. MSL Oncology (New Haven, CT)
REMOTE, CT 00000 US
Pipeline MSLs serve to enhance the scientific credibility of the Company with established and emerging clinical investigators as well as key scientific institutions and collaborative study groups, by supporting scientific dialogue and collaborations in the areas of research, medical and scientific exchange, including facilitation of requests for scientific and medical information. pMSLs also participate in close partnership with Site Management & Monitoring staff in the initiation, oversight, and follow-up of clinical studies. They also interface with other key members of US Medical Affairs (e.g. Medical/Scientific Directors, other MSLs, US Medical Operations), other Clinical Research functions such as Health Economics and Outcomes Research, Clinical Development, and others as appropriate - relevant to the therapeutic area for which the pMSL has responsibility and work collaboratively and cross-functionally with other in-field members while retaining functional independence. They maintain a high level of scientific knowledge to ensure credible dissemination of scientific information and informed scientific dialogue with key external stakeholders.
Ensure a strong medical and scientific presence for in Enterprise Critical investigational sites and key scientific centers by the facilitation of clinical research in interventional phase 1-3 trials with drugs, while supporting requests for medical and scientific information on products or areas of therapeutic interest.
Engage with Clinical Trial Site Investigators and Staff to understand enrollment/screening barriers from a medical perspective and work with the site and to find potential medical solutions. Aiming to support clinical trial enrollment.
Establish and maintain a close working relationship with Site Management & Monitoring staff and partner in facilitating the initiation and conduct of prioritized led clinical trials.
Provide scientific and technical leadership to ensure professional and credible relationships with investigators.
Consult with physicians, pharmacists, and other medical professionals, in compliance with relevant laws and regulations, to refer appropriate patients to Clinical Trial sites and review clinical practice topics as requested by the investigator or referring sites.
Act as the point of contact with thought leaders for investigator-initiated study (IIS) ideas with pipeline assets and requests for support with the USMA TA MDs and the global medical teams as appropriate.
Deliver credible presentations on scientific matters in the disease area of responsibility and about pipeline to investigators in sponsored interventional research.
May participate in the selection process by suggesting sites and investigator names to help identify appropriately qualified external experts the Company would wish to engage in collaborative efforts – such as potential research collaborations, or educational and advisory roles (Advisory Boards, Congresses, Symposia, etc.); while ensuring a high level of scientific or educational integrity in these collaborative efforts.
Identify opportunities for R&D collaborations with key institutions and External Experts and liaise with the Search & Evaluation team and Discovery or Clinical Development teams to facilitate further assessment.
Facilitate medical and scientific field intelligence – for example, maintain a list of investigators/potential investigators within a given TA, understand competitive research activities in active or planned study sites, generate insights from investigators on challenges and opportunities for sponsored clinical trials – and communicate, where appropriate, within the Company.
Attend relevant scientific meetings and Conferences and may represent in scientific booths at congresses.
Upon request, assist physicians with requests for access to medicines on a named patient or compassionate use basis, subject to all applicable legal and regulatory requirements.
May contribute to the 1-7-5 early touchpoint process: provide insights on the current clinical practice, facilitate identification of tier 1 external experts, and provide scientific input into the future clinical development program for pipeline assets.
Ensure that all activities and interactions are conducted with due regard to all applicable local, global, and national laws, regulations, guidelines, codes of conduct, Company policies and accepted standards of best practice.
ACCOUNTABILITY & SCOPE:
Support Enterprise Critical Studies’ related activities from a medical affairs perspective and contributing to meeting study timelines.
Provide scientific and technical input to local study teams, (early) brand teams and external investigators using information that has been reviewed and approved by relevant local procedures, and under the direction, governance, and oversight of the pMSL’ s manager, therapeutic area the USMA TA MDs and the global medical teams as appropriate. This includes working with local Medical Information teams, as appropriate, to respond to unsolicited requests for off-label information on medicines.
Ensure adherence to all applicable national laws and regulations, guidelines, codes of conduct, standards, policies, and procedures.
Develop and maintain collaborative relationships with investigators and thought leaders in the product / therapeutic area for which the pMSL has been assigned responsibility, to facilitate research and contribute to the success of our pipeline.
This function is typically field based. Up to 15% of an individual’ s time may be spent working in the head office if needed – the remainder of time being spent as field based. This is subject to needs, and the discretion of the pipeline Field Director and TA Head.
Advanced degree (e.g., PharmD., MD, PhD) in a relevant scientific discipline is strongly preferred but candidates with an undergraduate degree in a relevant discipline and demonstrated experience will be considered.
Experience in developing and maintaining expert knowledge for the assigned therapeutic area, and in medical research in general.
Professional experience as MSL or CRA or in a similar field-based R&D role for at least two years.
Solid knowledge of the pharmaceutical environment and the role of Medical Affairs to advance the medical and scientific objectives of a pharmaceutical company.
Demonstrated expertise in the scientific methods applied to clinical research and current legislative/regulatory controls applicable to this research.
Ability to comprehensively learn about new subject areas and environments.
Excellent written and spoken communication and presentation skills, with a demonstrated ability to develop and maintain strong collaborative relationships with thought leaders, physicians and other healthcare decision makers.
A good understanding of written and oral English is desirable.
High HCP orientation.
Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
Senior pMSL criteria:
Greater than or equal to 2 years as a Medical Science Liaison required.
At least 3 years of clinical, scientific research or industry related experience or equivalent required.
Previous pharmaceutical industry experience within relevant scientific discipline preferred.
Ability to identify, analyze, and translate specific territory and corporate needs in order to support both internal and external customers and achieve business and clinical objectives.
The Senior Medical Science Liaison must be able to identify, analyze, and translate specific territory and corporate needs in order to support both internal and external customers and achieve business and clinical objectives.
*CO candidates may not be considered