Clinical Development Medical Director, Hematology (MD)

Novartis • Full-time • United States, New Jersey (NJ), East Hanover • $0 / hour • 2w ago

22! The number of oncology drugs we have on the market and more than 25 new molecular entities in development targeting key molecular pathways in cancer biology. And while we're proud of that, in this world of digital and technological transformation, we must also ask ourselves, how can we continue to improve and extend even more lives?

As our Clinical Development Medical Director, Hematology, you will be the clinical leader of defined program level activities (e.g., submission activities, briefing books, etc.), or a large trial, under the leadership of the Global Program Clinical Head (GPCH). You may lead a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase).

Your key responsibilities:
• Provide clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable. Clinical deliverables may include clinical sections of individual protocols consistent with the Clinical Development Plans (CDP), clinical & medical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
• Lead development of medical/clinical sections of trial and program level regulatory documents (e.g., Investigator's Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
• Drive execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates if applicable
• Coordinate/conduct ongoing medical and scientific review of clinical trial data with Clinical Scientific Experts (CSEs)
• Support the GPCH in ensuring overall safety of the molecule for the assigned section, may be a core member of the Safety Management Team (SMT), and support overall program safety reporting (e.g., Periodic Safety Update Reports [PSURs], Drug Safety Update Reports [DSURs], and other safety related documents) in collaboration with the Patient Safety department
• Support the Clinical Development Head (CDH) by providing medical input into CDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other therapeutic area responsibilities as directed by the CDH
• As a medical expert, support the GPCH or CDH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards
• May be the Program Manager of other associates (e.g., CSEs).
• May work with NIBR (Novartis Institute of Biomedical Research)/Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with Business Development & Licensing (BD&L)What you'll bring to the role:
• MD license required. Advanced knowledge and clinical training in Oncology and/or Hematology), with Medical Board Certification preferred and 5+ years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV, with 3+ years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry
• Advanced knowledge of assigned therapeutic area (Classic & malignant Hematology)
• Proven ability to establish strong scientific partnership with key stakeholders
• Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/ clinical development process
• People management experience preferred; this may include management in a matrix environment. Global people management experience desirable
• Excellent negotiation, conflict resolution and communication skills (written and oral). Strong interpersonal skills
• Fluent oral and written communication.
Desirable:
• Clinical practice experience with 4+ years (including residency) preferred
• Previous global people management experience is preferred, though this may include management in a matrix environment.

You'll receive:
Competitive salary, annual bonus, pension scheme, share scheme, health insurance, 25 days annual leave, flexible working arrangements, subsidized dining facilities, employee recognition scheme and learning and development opportunities as well.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:

https://talentnetwork.novartis.com/network
Why Novartis?

769 million lives were touched by Novartis medicines in 2020, 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!

The pay range for this position at commencement of employment is expected to be between $257,600-386,400 a year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. 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.