Manager-Scientific Affairs / Medical Services

ORGANISATIONAL OVERVIEW

Lambda Therapeutic Research stands at the forefront of the global Clinical Research Organization (CRO) landscape, with its headquarters in Ahmedabad, India, and a presence extending across Mehsana (India), Las Vegas (USA), Pittsburgh (USA), Toronto (Canada), London (UK), and Warsaw (Poland).

Our unwavering mission revolves around providing comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. Lambda consistently sets new standards in the Clinical Research sector, achieving milestones through both organic growth and strategic acquisitions. In 2019, we strategically expanded our North American presence by acquiring Novum Pharmaceutical Research Services, a distinguished 50-year-old CRO. This strategic move, following the integration of Biovail’s R&D facilities in Canada in 2010, marked Lambda’s second significant acquisition in North America. It is a key player in the CRO industry.

Lambda Therapeutic Research has earned widespread recognition for its dedication to excellence, including being named the ‘Best Indian CRO’ by Frost & Sullivan (USA) and receiving the esteemed title of ‘Great Indian Workplace’ by UBS Transformance. Recently, Lambda proudly received the ‘Regulatory Excellence‘ Award at the CPhI Awards 2023 and the ‘Industry Partner of the Year‘ Award at the Global Generics & Biosimilar Awards 2023. Lambda has also been acknowledged by Industry Outlook as one of the Top 10 CROs (Contract Research Organizations) 2023. These accolades underscore our unwavering commitment to regulatory compliance, industry leadership, and impactful collaborations within the biotech, pharmaceutical and clinical research sectors.

JOB DETAILS

The MM is responsible for executing medical monitoring activities for the assigned studies. MM is an individual contributor. MM is expected to help execute clinical studies under the leadership of the Lead-MM which includes help in designing, implementing, conducting, monitoring and analysis of clinical studies.

KEY DELIVERABLES

• Maintains the working scientific and clinical knowledge in the specific disease area(s) of assignment.
• Maintains good knowledge of clinical study documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, and policies.
• Provide scientific support to the Lead-MM and clinical study team. Eligibity  review to be done as assigned to studies.
• Participates in ongoing clinical study team and relevant sub-team meetings, other interactions and communications. Responsible for the presentation of results and updates of projects at department, project, corporate and scientific meetings.
• Acts as a medical monitor for assigned studies and serves as a clinical point of contact for cross-functional teams and program-level stakeholders.
• Performs or oversees various medical monitoring activities including the ongoing medical review of the study data as per the medical data review plan. Conducts clinical review of study data; identifying and evaluating study data trends, outliers, protocol violators, etc. and working with others to develop and communicate relevant medical inquiries.
• Performs onsite medical monitoring visit and provide visit report on time to Lead-MM and the sponsor.
• Works with a high level of autonomy, providing decision accountability for the project, owns escalations, and communicates effectively at all levels.
• Partner in the execution of the program and/or clinical study (during study set up, conduct, recruitment activities, closeout, and reporting) in collaboration with Lead-MM.
• Prepare/review the clinical sections of the study and program-level regulatory documents created and amended for the study as delegated by the Lead-MM to ensure medical appropriateness.

ALLIED RESPONSIBILITIES

• Core clinical research-related knowledge: Knowledge of Good Clinical Practices ICH/GCP, drug development process, clinical research methodology, and basic biostatistics.
• Ethics: Highest personal and ethical standards. Demonstrates, or proven ability to demonstrate GCP Values.
• Interpersonal skills: Good interpersonal, verbal communication and influencing skills. Can influence without authority.
• Business acumen: Has sufficient knowledge of the clinical research industry and the multiple functions and roles involved in the drug development process.
• Communication skills: Open, active and inspiring communicator with a professional communication style.
• Presentation skills: Good presentation skill.
• Technology: Working proficiency with Microsoft Office platforms and resources (i.e. Word, Excel, PowerPoint) and virtual platforms are required.
• Travel: Ability to travel (domestic) approximately 30% of the total on-job time.

EXPERIENCE

• 0-2 years of progressively responsible experience in clinical research in an academically based research institute, or related experience within the industry (pharmaceutical, biotech, CRO, etc.) is required.

EDUCATIONAL QUALIFICATION

A minimum of a bachelor’s degree in a clinical medicine discipline is required, with an advanced degree (i.e., MD) preferred.

COMPETENCIES