Clinical Program Lead (CPL) - RLT Focus

U175 (FCRS = US175) Novartis Institutes for BioMedical Research, Inc.; Cambridge (MA); Hybrid; USD 249,000 - 462,000; Full time

Job summary

Novartis Institutes for BioMedical Research, Inc. in Cambridge, MA is seeking a Senior CPL or CPL to provide strategic medical leadership for oncology programs from preclinical entry through Transition Decision Point, with a hybrid onsite arrangement.

You will develop clinical strategies, lead cross-functional teams, supervise early development activities, and ensure rigorous data interpretation and regulatory compliance in pursuit of potential registrational trials.

Qualifications

• MD or DO degree Board-certification in an oncology specialty and PhD-level science are preferred
• Fluent English – Oral and written
• At least 2 years of pharmaceutical/biotech industry experience in oncology clinical trials plus the equivalent duration experience from an academic medical center.
• If limited or no Pharmaceutical industry experience, then comparable senior academic experience in translational oncology and clinical research
• Experience within RLT preferred
• Recognized as an expert in your field by external medical experts.
• External candidates have a substantial record of publication and international recognition
• Excellent interpretation of oncology preclinical data (molecular biology, pharmacology, pharmacokinetics, and toxicology)
• Strong 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 for clinical trials and oncology
• Excellent medical/scientific writing skills
• Successful track record of strategic thinking
• Proven ability to develop and inspire project/line/matrix multidisciplinary teams in a global environment
• Excellent personal ethical integrity and a commitment to improving the outcomes for patients with malignancies
• Excellent written and oral English communication/presentation skills
• Strong office IT skills

Responsibilities

• Provide strategic medical leadership to project teams for oncology development from preclinical to TDP
• Create development strategies for PE/DC to TDP
• Deliver solutions across functions and global projects
• Develop early clinical development strategies to support registration trials
• Lead IDPA development with DALs, DEV, S&G, and Commercial
• Lead Biomedical Research Early Program Teams to enable clinical development

Skills

Fluent English – Oral & written

Oncology clinical trials experience

Pharmaceutical/biotech industry

RLT experience

External recognition by peers

Publication record

Education

MD or DO degree

PhD-level science

Job description

Job Description Summary

Location: Cambridge, MA. Hybrid. May consider DWA, but candidates local to onsite preferred #LI-Hybrid. Experience will determine which level 6 (Senior CPL or CPL) is appropriate after interview process based on skills and experience. CPL: Provides strategic medical guidance and leads the development of experimental oncology agents in the TCO portfolio, beginning with PE / DC (Portfolio Entry / Drug Candidate) of preclinical development and continuing through TDP (Transition Decision Point).

Major Accountabilities

• Provides strategic medical and scientific leadership and expertise to all line functions on the project team for the development of new oncology agents (e.g., small molecules, biologics, radioligand therapies) that are in preclinical development, typically beginning at the PE / DC


• Creates clinical development strategies for new oncology agents within the PE/ DC to TDP timeframe. The development strategy combines the CPL’s medical knowledge with the expertise of colleagues in a wide range of other disciplines (e.g., Clinical Pharmacology, Biostatistics) to optimize the clinical development strategy.


• Delivers solutions within functions, across functions, and on global projects, developing independent approach to TCO strategy.


• Although registration studies are not within the responsibility of TCO, the CPL must provide an early clinical development strategy that foresees and supports subsequent registration trials.


• Development of the Integrated Development Plan Approval (IDPA) in alignment with CPL Disease Area Leads (DALs), Development (DEV), Strategy & Growth (S&G), and Commercial teams


• Lead Biomedical Research Early Program Teams (BPTs) to enable the start of clinical development and continuing through clinical trials needed to support TDP.


• May lead multiple global project teams


• Integrates preclinical information (pharmacology, toxicology, and pharmacokinetics) and interprets 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 develop the instruments needed to implement, interpret and report them (e.g., case report forms, report and analysis plans, clinical study reports)


• Applies own medical knowledge to guide the safe, ethical and efficient conduct of the trials under own responsibility.


• 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 oncology, and represents own 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.


• Operational responsibility for quality and compliance


• May provide informal mentorship to less experienced CPLs

Qualifications

• MD or DO degree Board-certification in an oncology specialty and PhD-level science are preferred


• Fluent English – Oral and written


• At least 2 years of pharmaceutical/biotech industry experience in oncology clinical trials plus the equivalent duration experience from an academic medical center.


• If limited or no Pharmaceutical industry experience, then comparable senior academic experience in translational oncology and clinical research


• Experience within RLT preferred


• Recognized as an expert in your field by external medical experts.


• External candidates have a substantial record of publication and international recognition


• Excellent interpretation of oncology preclinical data (molecular biology, pharmacology, pharmacokinetics, and toxicology)


• Strong 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 for clinical trials and oncology


• Excellent medical/scientific writing skills


• Successful track record of strategic thinking


• Proven ability to develop and inspire project/line/matrix multidisciplinary teams in a global environment


• Excellent personal ethical integrity and a commitment to improving the outcomes for patients with malignancies


• Excellent written and oral English communication/presentation skills


• Strong office IT skills

Compensation and Benefits

The salary for this position is expected to range between $248,500.00 - 461,500.00 USD Annual per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Salary Range $248,500.00 - $461,500.00

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

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 to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Skills Desired

• Clinical Research


• Clinical Trial Protocols


• Clinical Trials


• Clinical Trials Monitoring


• Decision Making


• Drug Development


• Health Sciences


• Medical Strategy (Inactive)


• Regulatory Compliance

Other Information

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