USA - Medical Dir. II

Company: Artech LLC
Location: East Hanover
Posted on: March 20, 2023

Job Description:

10+ years experience
Can be remote
Pay rate range: *** - ***

The Senior Clinical Development Medical Director (Sr. CDMD) is the clinical leader of a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase), or a large, complex trial, under the leadership of the (Sr.) GPCH. The Sr. CDMD may lead clinical programs, depending on the size, nature and complexity Major Activities

1) Provides clinical leadership and strategic guidance for all clinical deliverables in the assigned section of a clinical program or programs. Clinical deliverables may include the clinical development strategy for assigned program section(s), 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
4) Ensures ongoing medical and scientific review of clinical trial data
5) Is the Program or Function Manager of associates (e.g., CD(A)MD, CD(A)D, (A)GTD)
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) Leads the Global Clinical Team (GCT), if there is a separate GCT for the assigned program section. Represents the section when needed in Global Program Team (GPT) meetings, and as the section spokesperson in internal and external meetings/boards, as needed
9) 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
10) 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
11) May work with NIBR (*** Institute of Biomedical Research)/ Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with Client&L (Business Development & Licensing) including target identification and due diligences together with other medical matters, as needed
12) Ensures career development of Function and Program reports and other clinical colleagues through active participation in the performance management and talent planning processes. Provides on-boarding, training, & mentoring support
13) Contributes to medical/scientific training of relevant *** stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training
14) May serve on or lead global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives) Key Performance Indicators
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
Well managed, effective, and engaged clinical teams; demonstrated ability to deputize for (Sr.) GPCH at GCT, as well as other venues as needed
Clearly demonstrates *** Values and Behaviors Job Dimensions
Number of associates:
Leads team of up to 25 direct and indirect 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 *** 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 Ideal Background (State the preferred education and experience level)

Education (minimum/desirable):
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 e 4 years (including residency) preferred
Languages:
Fluent oral and written English
Experience/Professional requirement:
e 7 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. e 4 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
e 3 years people management experience required, 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

Keywords: Artech LLC, New York , USA - Medical Dir. II, Healthcare , East Hanover, New York