The Medical Director Oncology will serve as US Medical Director for multiple global clinical development trials and/or US Medical Affairs Trials (including phase I-IV, Expanded Access, Investigator Initiated, registries and Compassionate Use). The Medical Director will also Interface with the oncology therapeutic area Global and US Clinical Team Members, Clinical Operations, Scientific Operations, Regulatory Affairs, Drug Supply, Data Management, Finance, Quality, Compliance, and other relevant functional areas.
Your responsibilities include, but are not limited to:
• Design and optimize clinical trial design and ensure clinical trials meet ethical and regulatory standards including:
*Write and review protocols that are in-line with the overall indication strategy.
*Conduct medical review and interpretation of efficacy and safety data from clinical trials.
• Responsible for the quality, coordination, medical accuracy, and timeliness of clinical study reports, clinical sections of INDs, Investigator Brochures, CTAs, ISS’s, ISE’s, clinical expert reports, and label reviews.
• Review and provide US feedback to Global Protocols and Global Development Plans.
• Develop strategy for US Medical Affairs including exploratory indications and integrate US plan with overall Medical Affairs strategy. Oversee the review and approval of IIT concepts. Oversight during the conduct of trials including safety monitoring. Review of interim and final publication, manuscripts, or abstracts.
• Provide strategic input or develop strategy for US clinical trial programs. May also evaluate global strategy for the clinical trial programs.
• May supervise and manage individuals on the US disease team as appropriate. Lead the Clinical Team, including interactions with Safety, HEOR, Marketing, Regulatory, Research, and other functions.
Work with Clinical Team and other functions to prepare abstracts, manuscripts and presentations for external meetings as well as author clinical sections of regulatory documents (i.e., IB, IND sections), for Company Sponsored project.
• Review and approve abstracts publications & manuscripts for Investigator Initiated Trials to ensure clinical accuracy and appropriate safety review.
The pay range for this position at commencement of employment is expected to be between $233,600.00 and $350,400.00 per year; however, while salary ranges are effective from 1/1/22 through 12/31/22, 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.
Minimum requirements
What you’ll bring to the role (Requirements):
• MD, PhD Pharm D, or equivalent required. If MD, Board Certified or board eligible in either Hematology or Oncology, or relevant Medical Specialty.
• At least 3-10 years of experience in Hematology/Oncology clinical research in the pharmaceutical industry OR experience in clinical research or medical affairs is preferable or a combination of experience in academic medicine with clinical research and or clinical development experience in collaboration with the pharmaceutical industry.
• Scientific medical research experience in Oncology and or Hematology (or relevant specialty) with demonstrated record of scientific medical publications.
• Experience leading the design, conduct, analysis and reporting of clinical studies is strongly preferred.
• Superior leadership, networking, collaboration and communication skills.
• Successful interactions with Medical Experts and investigators.
• Demonstrated the capability for strategic planning along with operations skill and experience related to clinical research involving both single and multiple centers.
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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 send an e-mail to [email protected] or call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
COVID-19: While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected].
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: https://talentnetwork.novartis.com/network
About the rolePosition is located in Cambridge, MA or San Diego, CA As Executive Director and Global Head for Cell...
Apply For This Jobbr{display:none;}.css-58vpdc ul > li{margin-left:0;}.css-58vpdc li{padding:0;}]]> Helpdesk Support Specialist If you are a Helpdesk Support Specialist with experience, please read on!...
Apply For This JobAbout the roleBringing life-changing medicines to millions of people, Novartis sits at the intersection of cutting-edge medical science and innovative...
Apply For This JobJob Description13! The number of medicines Cardio Renal Metabolic diseases currently in development at Novartis. Novartis is deeply committed to...
Apply For This JobJob Description In case you haven’t heard of us Our company is a global health care leader with a diversified...
Apply For This Jobbr{display:none;}.css-58vpdc ul > li{margin-left:0;}.css-58vpdc li{padding:0;}]]> Job Summary Performs and implements assignments that impact important /complicated components/processes of the specified functional...
Apply For This Job