Jubilant Bhartia Group is a global conglomerate founded by Mr. Shyam S Bhartia and Mr. Hari S Bhartia with strong presence in diverse sectors like Pharmaceuticals, Contract Research and Development Services, Proprietary Novel Drugs, Life Science Ingredients, Agri Products, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services. Jubilant Bhartia Group has four flagships Companies- Jubilant Pharmova Limited, Jubilant Ingrevia Limited, Jubilant FoodWorks Limited and Jubilant Industries Limited. Currently the group has a global workforce of around 43,000 employees.
Jubilant Pharmova Limited
Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is a company with global presence that is involved in Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables, Contract Research Development and Manufacturing Organisation (CRDMO), Generics and Proprietary Novel Drugs businesses.
In the Radiopharma business, the Company is involved in manufacturing and supply of Radiopharmaceuticals with a network of 46 radio-pharmacies in the US. The Company’s Allergy Immunotherapy business is involved in the manufacturing and supply of allergic extracts and venom products in the US and in some other markets such as Canada, Europe and Australia. Jubilant through its CDMO Sterile Injectables business offers manufacturing services including sterile fill and finish injectables (both liquid and lyophilization), full-service ophthalmic offer (liquids, ointments & creams) and ampoules.
The CRDMO business of the Company includes the Drug Discovery Services business that provides contract research and development services through two world-class research centres in Bangalore and Noida in India and the CDMO-API business that is involved in the manufacturing of Active Pharmaceutical Ingredients. Jubilant Therapeutics is involved in Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and autoimmune disorders. The company operates six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies.
Find out more about us at www.jubilantpharmova.com
The Position
Organization: - Jubilant Pharmova Limited
Designation & Level: - Associate Director Medical
Location: - Yardley, Pennsylvania
Job Summary: - The Associate Director Medical role-plays a vital role in overseeing the clinical, regulatory, and medical aspects of a pharmaceutical company's operations, ensuring the safe and effective development and use of pharmaceutical products.
Reporting Manager: - Chief Medical Officer
Key Responsibilities
Scientific support to Scouting / Business Development
Medical Support to Discovery and Non-Clinical Development
Strategic planning and scientific supervision of development and market support programs
Support to Medical Affairs Scientific interactions with opinion leaders / lead users / customers
Medical Support to Medical Communications and Medical Education programs and activities
Support to Marketing for all products.
Support for Clinical development of new products / new indications for existing products.
Support in Preparation, review and update of clinical development programs and preparation of protocol outlines for core pre-approval, phase I-IIIa clinical studies;
Support to Regulatory Affairs, e.g. scientific and medical support to the preparation of INDs or to the preparation and conduct of meetings with regulatory authorities, or by providing scientific and medical support to the preparation of NDAs;
Support to Corporate Operations, e.g. input to the selection of investigators; scientific and medical support to investigators' meetings and investigators' training sessions; medical support to the resolution of safety and efficacy issues that may arise during the conduct of pre-approval, phase I-IIIa studies; medical input and review statistical analysis plans, TLFs and final reports.
Support to Pharmacovigilance: Medical Support to Pharmacovigilance Team
As needed, provide support and scientific information to the customer with respect to safety profile of products and devices virtually and as needed with in-person visits
Medical Support to Regulatory Affairs:
Preparation and conduct of meetings or requests with regulatory authorities,
Providing scientific and medical support to the preparation of NDA’s and sNDAs
Providing scientific and medical support to the preparation of The Core Data Sheet (CDS) for approved products
Support to Marketing:
Preparation and update of phase IIIb-IV clinical programs to support product positioning, and the preparation of protocol outlines for phase IIIb-IV clinical studies;
Review and scientific support to planning and conduct of phase V studies (extramural clinical research).
S cientific support to the preparation of publication plans and scientific communications (abstracts, presentations, posters, articles);
S cientific support to the preparation of promotional material / Review of scientific contents of promotional material.
Support to Innovation and R&D:
Identifying and presenting unmet medical needs;
Reviewing and presenting medical issues that may help in the screening and/or the evaluation of new compounds as potential new products;
Supporting Scouting and Discovery Teams in the definition of the (written) criteria the new candidates must meet to be considered a potential new product;
Scientific support to Business Development in the evaluation of external opportunities;
Support to preparation and review of non-clinical development programs
Review of results of non-clinical studies and review of pre-phase I information designed to be included in Clinical trials Applications and support early clinical investigations in man;
Medical support to intellectual property activities.
Medical Services:
Engaging in medical/scientific field interactions with customers and sales representatives, and providing virtual and in-person scientific product presentations, to support product adoption and use
Provide extensive scientific information/education about products to centralized officials (pharmacy directors, value analysts, quality coordinators, supply chain specialists, hospital administrators) of IDNs and GPOs who do not know much about imaging or imaging products, but make decisions about their purchase and use
Representing the company at major professional scientific meetings as needed and appropriate including but not limited to North America, Europe, India, etc. interacting with thought leaders, evaluating latest scientific information relevant to our product, and answering questions from and meeting with customers
Training the sales representatives, account managers and clinical application specialists and medical scientific liaisons in scientific/clinical information and issues
Representing the company at professional meetings, congresses and symposia including not limited to the North Americas but global, while interacting and building relationships with thought leaders and key users in the medical imaging industry throughout the globe
Medical Support to Medical Information Services / Sales / Corporate Accounts:
Medical support the increasing needs of Sales and customers for professional information
Answer questions from Medical Information Services, assisting them with (or developing) their responses to customer queries
Provide expert medical responses to queries from sales representatives and customers in North America and Globe
Present medical/scientific information to: (a) internal business personnel (for training), (b) health care professionals (for scientific interaction), and (c) current or potential customers or users (for product support)
Support the investigator-initiated research program with products globally
Medical Support to Medical Communications and Medical Education programs and activities
Ongoing medical support to internal Medical Communications and Medical Education personnel to guide the creation and execution of symposia and educational activities
External Interfaces:
Physicians, Medical Oncologists/Internal Medicine/Cardiologists/technologists/Radiation Safety Officer/Medical Physicists
Internal Interfaces:
Sales/Marketing/R&D/QA/Regulatory/MDDT/ Customer Service
Person Profile
Qualifications:-
Doctor of Medicine (M.D.) or Doctor of Osteopathic Medicine (D.O.)
Board Certification in Internal Medicine and/or Nuclear Medicine (Mandatory)
Advanced degree sub speciality a plus
Experience:-
Total 8-10 years of experience in Medical with Pharma Industry. At least 5 years of experience in Medical with pharmaceutical industry and mandatory 5-7 years of clinical practice experience with hospitals.
Extensive practical experience in the field of radiopharmaceuticals or nuclear medicine, either in a clinical, research, or in regulatory capacity, is essential for this role. This ensures the candidate has a deep understanding of the industry and can effectively manage the various aspects of the radiopharmaceutical company.
Specialized board certification in internal or nuclear medicine is typically required, as the Medical Associate Director will be responsible for overseeing the use and application of radiopharmaceuticals in medical imaging and treatment.
Well-versed in the regulatory requirements and guidelines governing the development, manufacturing, and use of radiopharmaceuticals, such as those set forth by the U.S. Food and Drug Administration (FDA) and other relevant regulatory bodies.
Responsible for leading a team of healthcare professionals and overseeing the clinical and operational aspects of the pharmaceutical company. Strong leadership, decision-making, and management skills are essential for this role.
Liaises with various stakeholders, including physicians, patients, and regulatory bodies, to address concerns and facilitate the successful development and commercialization of drugs/ radiopharmaceuticals.
Excellent written and verbal medical communication skills, with the ability to convey complex information clearly and persuasively.
Strong interpersonal skills and the ability to build and maintain relationships with internal and external stakeholders at all levels.
Ability to multitask, prioritize competing demands, and meet deadlines in a dynamic environment.
Jubilant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, citizenship, colour, gender identity or expression, genetic information, marital status, medical condition, national origin, political affiliation, race, ethnicity, religion or any other characteristic protected by applicable local laws, regulations and ordinances.
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