- The Precision Medicine Lead (PML) supports asset programs by enhancing the probability of success and de-risking the development of Teva's early drug candidates.
- The PML is responsible for the planning and execution of the Experimental Clinical Development Plan and for providing clinical and scientific input into the overarching Translational and Precision Medicine Strategy for the assigned Immunology therapeutic area (TA) drug asset(s) in accordance with Teva priorities.
- Collaborates with the Immunology TA and clinical development leadership to enhance candidate selection and develops comprehensive clinical and scientific de-risking plans for the assigned drug candidate(s) to move into the late stage of clinical development.
- (Co)leads a cross-functional Early Clinical Development Team(s) and is responsible for the design, planning, executional oversight, medical monitoring, and interpretation of Experimental Clinical Studies (including Phase 0, Phase 1b, proof of activity and concept, adaptive, master protocol, window of opportunity studies) and ensures that clinical studies operate with scientific rigor, comply with the highest ethical and safety standards and are compliant with clinical, ICH and GCP guidelines as well as Teva SOPs.
- Identifies and seeks to validate novel endpoints for early decision making and identifies patient or target population stratification strategies to support the rapid demonstration of safety and efficacy (surrogate biomarkers, intermediate clinical endpoints, digital COAs).
- Reviews preclinical data for clinical implications and integrates preclinical information to progress molecules from nomination to early clinical development stages.
- In collaboration with other functions, leads the development of the study concept and related documents and the delivery of the final protocol and its governance approval.
- Responsible for providing clinical input into the implementation of a clinical trial(s), their management, clinical data review, and interpretation of results.
- Serves as the main point of contact for clinical issues raised by collaborators, investigators, and consultants, provides ongoing medical input into study documentation, and participates in the pharmacovigilance reporting process.
- Conducts the analysis and interpretation of interim and final study data, writing of final study reports and summaries for regulatory submission.
- Leads the dissemination of study data and results internally and externally, including the development of publications, abstracts, and presentations.
- Participates in the planning, writing, and leading relevant modules of regulatory documents and applications, represents clinical strategy and study results and interpretation at regulatory interactions, as appropriate.
- Represents Teva at scientific meetings, advisory boards, KOL boards, and meetings with regulatory agencies, as needed.
- Forms and fosters partnerships with a wide spectrum of external experts and collaborators, agencies, academic and industry opinion leaders.
- M.D., M.D./Ph.
- Minimum 3 years of early clinical research experience, expertise in experimental and precision medicine research.
- Relevant experience in pharmaceutical/biotech or related industries.
- Clinical training, board eligibility/certification, and knowledge in immunology - dermatology, rheumatology, gastroenterology, respiratory.
- Experience with regulatory interactions.
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Director Precision and Experimental Medicine - Parsippany, United States - Teva Pharmaceuticals
Description
Director Precision and Experimental Medicine - ImmunologyDate:
Apr 18, 2024
Location:
Parsippany, United States, New Jersey, 07005
Company:
Teva Pharmaceuticals
Job Id: 53754
Who we are
Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives.
It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds.
Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List.
Today, at least 200 million people around the world take one of our medicines every single day.An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
Teva's R&D Global Early Clinical Development Team is hiring a Precision Medicine Lead (PML) - Immunology in the Translational and Precision Medicine group who will be accountable for the experimental and precision clinical development across Teva's Immunology therapeutic area (TA) early drug asset portfolio.
The PML will collaborate with the Immunology TA and global clinical development leadership to enhance candidate selection and develop comprehensive clinical and scientific de-risking strategies for the drug candidate(s) to move quickly into the late stage of clinical development.
The PML will (co)lead a cross-functional Early Clinical Development Team(s) in a matrix environment and will be responsible for the design, planning, conduct, and interpretation of early phase clinical studies for the assigned drug asset(s), in accordance with Teva's strategy and priorities.
In addition, the PML will be responsible for the composition of clinical study reports and regulatory submission documents and will participate in regulatory interactions, as appropriate.
The PML will interact and foster relationships with external experts, opinion leaders, and academic collaborators, lead scientific advisory boards, and represent Teva at scientific meetings and symposia.
Travel Requirements:
Approximately 10 -15% - presentations and/or attendance at approximately 2 domestic and/or 1 domestic + 1 international scientific association meeting per year, plus key opinion leaders, scientific advisory boards regulatory meetings, academic collaborations, consortia, and other strategic meetings as required.
How you'll spend your day
Your experience and qualifications
Education Required:
Experience Required:
Experience Preferred:
Enjoy a more rewarding choice
We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day.
We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees.
Use the following link to search and apply:
Internal Career Site \_company=1080030P)
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva's Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment.
It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
We are committed to a diverse and inclusive workplace for all.If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process.
All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
EOE including disability/veteran
