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Associate Clinical Development Medical Director

Associate Clinical Development Medical Director

Novartis Group CompaniesCambridge, MA, United States
30+ days ago
Job type
  • Full-time
Job description

Job Description Summary

The Associate Clinical Development Medical Director (Assoc. CDMD) is responsible for the scientific and medical strategy of assigned clinical trial(s), medical and scientific monitoring, and reporting of quality data. May be responsible for the scientific and medical strategy of assigned sections of a clinical development program, depending on the size and complexity.

Job Description

MAJOR ACCOUNTABILITIES :

Is a global clinical manager or country / cluster leader responsible for clinical program(s) across indications executing medical strategy for development and marketed products in a defined therapeutic area -Responsible for the scientific and medical strategy of assigned clinical trial(s), medical and scientific monitoring.

May be responsible for the scientific and medical strategy of assigned sections of a clinical development program.

Contributes to the development of clinical sections of trial and program level regulatory documents -Contributes to the execution of the section of the clinical program in partnership with global line functions.

Contributes to ensuring overall safety of the compound for assigned trial(s) in collaboration with Patient Safety.

Supports by contributing medical input into IDP and CTP reviews and contributing / driving development of disease clinical standards for new disease areas -Contributes to medical / scientific training of relevant Novartis stakeholders.

May serve as speaker for franchise medical / scientific training -Contributes to the global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives) -Contributes to talent and career development of CD associates through on-boarding, coaching, and / or mentoring support; -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

REQUIREMENTS

MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical / scientific area (e.g., internal medicine or sub-specialty) required, with Medical Board certification preferred; Clinical practice experience 4 years (including residency) preferred

3 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. 2 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

Working knowledge of the assigned disease area is desired with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level

Demonstrated ability to establish effective working relationship with key investigators

Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes

Strong communication skills, written and oral

Strong interpersonal skills

Strong negotiation and conflict resolution skills

Proven ability to work independently or in a cross-functional team setting

The salary for this position is expected to range between $204,600 and $379,400 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.

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 us.reasonableaccommodations@novartis.com 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.

Salary Range

$204,400.00 - $379,600.00

Skills Desired

Clinical Trials, Data Analysis, Data Monitoring, Drug Development, Drug Discovery, Medical Strategy, People Management

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Associate Director Clinical • Cambridge, MA, United States

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