- Leads the EPT, reports to clinical site head
- Provides strategic medical guidance for the development of new oncology agents (both small molecules, biologics, cell therapies and radioligand therapies) that are in preclinical development, typically beginning at the candidate selection phase.
- Creates a clinical development strategy for new oncology agents that are within the candidate selection to proof-of-concept (PoC) and transition to full development timeframe. The development strategy combines the CPL's medical knowledge with the expertise of colleagues in a wide range of other fields (e.g., Clinical Pharmacology, Biostatistics) to optimize the clinical development strategy.
- Although registration studies are not within the responsibility of TCO, the CPL in TCO must provide an early clinical development strategy that foresees and supports subsequent registration trials
- Integrates preclinical information (pharmacology, toxicology, pharmacokinetics) and interprets its implications for clinical development, as articulated in the Investigator's Brochure and first-in-human protocol.
- Collaborates with clinical scientists to develop clinical protocols for TCO compounds and to develop the instruments needed to implement, interpret and report them (e.g., case report forms, report and analysis plans, clinical study reports).
- Applies their medical knowledge to guide the safe, ethical and efficient conduct of the trials under their responsibility. They are knowledgeable in Good Clinical Practice guidelines and Novartis Standard Operating Procedures and strives to maintain compliance with them.
- Liaises with outside experts, investigators, and regulatory authorities in the field of oncology, and represents their projects to those groups and authorities.
- Writes and reviews abstracts/manuscripts, etc. for presentation/publications at internal/external meetings.
- Participates in task forces to support continuous improvement and other management objectives.
- Novartis: e-mail [email protected] or call
- Sandoz: e-mail [email protected] or call:
- This position will be located at the Cambridge, MA site and will not have the ability to be located remotely. This position will not require travel as defined by the business (domestic and/or international).
- MD or DO degree required. Hematology, Medical Oncology or both. MD, PhD preferred.
- 3-5 pharma/biotech industry experience in hematology/oncology clinical trials and the equivalent term experience in the academic setting. In case of no industry experience, substantially longer academic experience in translational oncology and substantial clinical study experience.
- Must have facility with the interpretation of preclinical data in heme/oncology (molecular biology, pharmacology, pharmacokinetics, and toxicology)
- Working knowledge of the application of PK/PD and biostatistics to clinical development and clinical trials
- Proven ability to analyze and interpret efficacy and safety data relating to oncology.
- Knowledge of GCP and world-wide regulatory requirements relating to clinical trials and oncology
- Excellent medical/scientific writing skills
- Effective written and oral communication skills
- Proven ability to manage and develop a team
- Excellent personal ethical integrity and a commitment to improving the outcomes for patients with malignancies
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clinical program leader - Cambridge, MA, United States - Novartis AG
Description
About the RoleINTERNAL ROLE TITLE:
Clinical Program Leader
LOCATION:
Cambridge, MA
#LI-Onsite
About the role:
To provide strategic medical guidance for and to the lead the development of experimental oncology agents in the TCO portfolio, beginning with the candidate selection phase of preclinical development and continuing through clinical proof-of-concept and transition to full development.
Your Key Responsibilities:
The pay range for this position at commencement of employment is expected to be between $257,600 and $386,400 / year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period.
Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities.
The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered.
Details of participation in these benefit plans will be provided if an employee receives an offer of employment.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Diversity & Inclusion / EEOWe are Equal Opportunity Employers and take pride in maintaining a diverse environment.
We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and Reasonable Accommodations:
Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
Essential Requirements:
Why Novartis:
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world.
How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions.Be a part of this mission and join us Learn more here:
You'll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment.
We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and Reasonable Accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call and let us know the nature of your request and your contact information.
Please include the job requisition number in your message.Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
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clinical program leader professionals in Cambridge
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Brian Sodano
Build Engineering Teams, Products, and Platforms.