Clinical Development Medical Director

East Hanover, NJ

5 - 7 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 12/15/17
East Hanover, NJ
5 - 7 years experience
Biotech/Pharma
Salary depends on experience
Posted on 12/15/17

 Job Description   

 The Clinical Development Medical Director (CDMD) is the clinical leader of defined program level activities (e.g. submission activities, briefing books etc.), or a large, complex trial, under the leadership of the (Sr.) GPCH. May lead a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase) Major Activities
1) Provides 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 Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
2) Leads development of 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)
3) Drives 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
4) Oversees/conducts ongoing medical and scientific review of clinical trial data with Clincal Scientific Expert(s)
5) May be the Program Manager of other associates (e.g.., CSE).
6) May act as study medical monitor
7) Supports (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section, may be a core member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety
8) Supports the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other TA responsibilities as directed by the TAH
9) As a medical expert, supports the (Sr.) GPCH or TAH 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
10) 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 BD&L (Business Development &
CDMD Page 2 of 3
Licensing) including target identification and due diligences together with other
medical matters, as needed
11) Ensures career development of Program reports and other clinical colleagues
through active participation in the performance management and talent
planning processes. Provides on-boarding, training, & mentoring support
12) Contributes to medical/scientific training of relevant Novartis stakeholders on the
disease area and compound/molecule. May serve as speaker for franchise
medical/scientific training
13) May serve on or lead global initiatives (e.g., process improvement, training, SOP
development, other Clinical Development line function initiatives)
Key Performance Indicators (Indicate how performance for this job will be measured)
• Timely delivery of high quality IDP sections, CTPs, and other clinical deliverables
aligned with IDP and TPP and endorsed by review committees and internal
boards, with acceptance by key external and internal stakeholders
• Applies effective clinical research methodology, including trial design/analyses,
efficacy endpoints, safety assessments, and risk management across disease
area and development phases
• Strong evidence of quality medical review of trial data; support TA through high
quality IDP and protocol reviews; timely development of quality disease/program
clinical standards, publications, internal/external presentations, and other CD
deliverables
• Strong evidence of quality contributions to and acceptance of clinical sections of
regulatory documents, Investigators’ Brochures, briefing books, safety updates,
and submission dossiers by key external and internal stakeholders
• Clearly demonstrates Novartis Values and Behaviors
Job Dimensions
Number of associates: May lead team of up to 5 reports (dependent on the
size of the programs and functional responsibilities)
Financial responsibility:
Overall lifetime clinical budget of program which can
vary and be in excess of $10 – 20 million.
Impact on the
organization:
External
• Timely submission and delivery of high quality
clinical program data supporting regulatory
approval of key compounds (or new indications), as
appropriate
• Effective interaction with and influence on key
external decision makers (e.g., regulatory
authorities, medical experts, pricing and
reimbursement bodies)
Internal
• Medically and scientifically sound programs and
trials resulting in the timely delivery of high quality
analysis of trial data which enables strategic
decisions within the clinical program
• High quality clinical/scientific review of CTPs and
CDPs, industry leading clinical processes
• Identification and development of key talent
EEO Statement     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 any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.


Minimum requirements   

 • MD degree is required.
Advanced knowledge and clinical training in a
medical/scientific area (e.g., internal medicine or
sub-specialty) required, with Medical Board
CDMD Page 3 of 3
certification preferred; Clinical practice experience ≥ 4 years (including residency) preferred
Languages:
Fluent oral and written English
Experience/Professional requirement:
• ≥ 5 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. ≥ 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
• Demonstrated 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 communication skills, written and oral
• Strong interpersonal skills
• Excellent negotiation and conflict resolution skills

227055BR

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