JOB DESCRIPTION:

Primary Function:

The primary role will be to act as clinical trial physician for sponsor in all assigned clinical programs whose core responsibility will be to ensure safety of all subjects and provide scientific/ medical expertise for all assigned trials

The role will also provides support to Global clinical directors to support development of clinical strategies for new EPD compounds in development to expand or maintain EPD compounds on the market. Ensures that all clinical development work for the compounds assigned is carried out in a timely manner with the required quality.

Core Role Responsibilities:

• Safety Physican Role: Responsible for the preparation/ review of safety aspect in clinical documents,clinical study concepts, clinical study protocols, Investigator’s Brochures, clinical study reports, clinical modules of CTD, response documents for EC, MoH on the program.

• Take on role of safety physician for global clinical studies/programs.

• Responsible for the medical oversight during trials and functions as SME for scientific and medical questions during the trials. Review of safety review plan, SAE reconciliation, safety listings and coding during the trials/programs

• Primary study contact for sites’ personnel and project team in the event of medical-scientific questions

• Collaboration with the other members of the Pharmacovigilance team to process Serious Adverse Events for the clinical trials to which is assigned as CRP

• Review of CROs-Medical assessment of adverse event reports, detecting and assessing risks and proposing risk mitigating activities

• Case Narratives review, Coding of medical terms

• Participating in Risk management activities like protocol modifications due to safety or efficacy concerns, restrictions in study population or indications, changes to the informed consent document relating to safety issues, newsletters to investigators

• Input in development of Safety Update Reports (PSUR and DSURs) and as necessary

• Providing therapeutic and protocol-specific training (including SAE reporting and handling) to the project teams and clinical sites Contribute to statistical analysis plan, blind data review meetings, lead data interpretation meetings and medical writing activities.

• Support Budget forecasting and Tracking for clinical studies/clinical development programs if needed

• Interacts with opinion leaders to collect their input as needed for the clinical project if needed

Cross Functional Collaboration activities to be performed in absence of GCD:

• Support the GCDs- for Clinical Development strategy, pipeline and evaluations as and when needed

• Back up for GCD f or new product development ideation and identify trends, clinical development strategy, clinical development plans as needed.

• Must keep abreast of development activities in TAs of interest and portfolio so as to support GTs.

• Review and evaluate due diligences for clinical development program, deliver new ideas for product innovations.

• Preparing the clinical part of the therapeutic area target product profiles (TPP) in alignment with PT/NST

• Being on top of medical scientific knowledge, evaluating and reviewing medical literature, based on these providing potential new improved therapeutic benefit ideas to enhance and maximize potential benefit for disease management and patient care for the TA.

• Acquires and shares clinical medical expertise in the therapeutic area and on the competitive treatments to support Clinical Operations, Medical Services, Marketing, Licensing & Acquisitions and Training teams. Effective communication in the teams, with stakeholders and with individuals.

• Adhere to the goals and motivate the team and reports, deliver business results

• Anticipation of business risks from different angles on the products and programs and proactively addressing them

• Translate the clinical strategic TA goals into operational reality.

• Customer insight driven inspiration driving business

Activities with PV in absence of GCD:

• Support the Product Safety Team as needed with regard to assigned products. Lead safety monitoring within all clinical activities under his/her, oversee the medical review or development of white papers,
• Cooperate with Global PV on the development of e.g. RMPs, PSURs and ACOs
• Activities with RA/Health Authorities: Will support below activities in absence of GCD
• Support for the development and maintenance of CTD sections 2.5 and 2.7, 2.7.4 ADR evaluation, defense the clinical part for the authority feedback, contribute to deficiency letters of authority requests regarding the clinical sections. Support the process of product-specific medical queries from the Health Authorities. Responsible for the development of integrated safety databases and/or integrated efficacy databases for the core products together with the biometrics department. Data mining of clinical studies data in order to provide new insights, e.g. global label extensions and publication of the output.
• Oversee the work of the Labeling Subteam Team(LST): provide medical evaluation and propose scientific strategies with regards to major national label change requests (including safety issues as requests for DDLs), with team responsible for global company scientific information (CCDS, Master SmPC
• Oversee clinical expert opinion for regulatory and safety documents, and medical assessments for QA related internal requests related to the products under responsibility
• Interacts with the Project Teams including Commercial, Regulatory Affairs, Medical Affairs and other disciplines to ensure that the clinical project fulfills the regulatory requirements and represents the company to the Regulatory bodies as appropriate on clinical matters.

Supervisory/Management Responsibilities:

Define the size of the organization under this position. How many employees may be directly/indirectly supervised by this position.

Direct Reports: 0

Indirect Reports: 0

Position Accountability/Scope:

• Responsible for the ensuring medical /safety aspects of subjects in clinical programs are in accordance with international medical/scientific and quality standards and aligned with EPD objectives
• Responsible for the safety monitoring, medical oversight in programs
• Accountable for providing in-depth clinical knowledge of the TA under consideration.
• Adequate people and stakeholder management, provides direction to achieve business objectives, efficiently delegate tasks and give clear guidance.

Minimum Education:

MD or MBBS:

Minimum Experience/Training Required:

At least 5-7 years of experience in pharmaceutical industry with minimum of 3 years in relevant clinical development. Ability to lead clinical programs and to run teams in multi-cultural environment at different sites. Expert knowledge of clinical trial methodology, oversight/evaluation of safety and regulatory requirements governing clinical trials. Developmental and Medical Insights of Emerging markets. Works independently, takes responsibility, strong communication silks (written and oral) in English.

• Core competencies: Communication, Customer Service Orientation, Decision Making, Risk anticipation, People management, including resource allocation
• Functional competencies: Coaching and Consulting, Cross-Team Integration, Planning & Organizing

The base pay for this position is

N/A
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Clinical Affairs / Statistics

DIVISION:

EPD Established Pharma:

LOCATION:

• India > Mumbai : Mumbai Development Center
• EPD

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)