Medical Director - GI Oncology
Company: Roche
Location: Sacramento
Posted on: January 23, 2023
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Job Description:
The PositionRoche's Clinical Development organization is
structured by therapeutic area and is responsible for developing
and executing the late development (Phase II - IIIA) clinical
strategies and plans that deliver medically-differentiated
therapies that provide meaningful improvement to patients. The PD
Medical Director/Lead Medical Director participates in development
of the Clinical Development (CD) strategy and is responsible for
developing the CD plan and ensuring effective and efficient CD plan
execution for the assigned molecule(s)/indication(s). PD Medical
Directors may have one or more direct reports. PD Medical Directors
are expected to perform their responsibilities with more
independence by comparison to Associate PD Medical Directors,
including participating in health authority (HA) interactions with
little to no supervision from their managers.1. Cross-Functional
Team Membership--- Participates in the relevant Clinical Science
Team (CST)--- Participates as a standing or ad hoc member in
sub-teams (e.g., Study Management Teams) relevant to assigned
molecule(s)/indication(s) and supports the CST lead and overall
team with cross-functional integration, coordination and alignment
to enable effective and efficient CD plan execution--- As
requested, supports the CST lead and overall team with training new
CST members--- May also, as appropriate, support relevant sub-teams
in training new team members2. Global Clinical Development
Planning--- Stays abreast of internal and external developments,
trends and other dynamics relevant to the work of CD to maintain,
at all times, a fully current view and perspective of
internal/external influences and/or implications for theassigned
therapeutic and disease area(s)--- As appropriate, participates in
competitive intelligence and/or other market/industry assessment
activities and projects--- Maintains the highest standards and
levels of scientific and clinical knowledge in the specific
therapeutic and disease area(s) of assignment--- Collaborates with
a variety of internal and external partners and stakeholders, such
as clinical investigators, clinicians, scientists and key opinion
leaders (KOLs), as well as multidisciplinary internal groups,
including other groups in PD, research, regulatory, business
development, commercial operations, legal, etc.--- Participates in
CD strategy development--- Supports other CST members with
development of clinical science information for inclusion into
annual and strategic Lifecycle Plans (LCPs) and the Integrated
Development Commercialization Plan (IDCP)--- May participate in
meetings, reviews, discussions and other interactions regarding
early development/Phase I studies to provide clinical science
development input and guidance. Includes reviewing Phase I
protocols and providing CD input into these--- Supports internal
partners in transitioning new drugs/indications into Phase IIIB or
publication studies. May review Phase IIIB protocols and other
information and provide CD input--- As assigned, may also consult
to pharma partnering on relevant acquisitions, joint ventures or
other strategicpartnerships, as these potentially relate to the
assigned therapeutic/disease area(s)--- Participates in development
of the CD plan for assigned molecule(s)/indication(s) and/or other
programs:o Gathers and analyzes data and information necessary to
create the CD plano Works with other CST members and relevant
sub-teams to develop CD plan components (e.g., analytics/data
strategy, KOL development, publications strategy, etc.)o Works with
CST and other relevant teams to develop and provide information and
input for budget/resource requirements necessary to implement and
execute the CD plan--- Supports other CST members in preparing for
HA meetings. As appropriate, participates in HA meetings.
Ethically, effectively and professionally represents the interests
of Roche and patients3. Clinical Development Plan Implementation---
Provides clinical support across all relevant studies and
programs:o Participates in ongoing CST and relevant sub-team
meetings, except Development Working Group (DWG), other
interactions and communicationso Designs and develops clinical
studies for review and discussion with other CST memberso May
collaborate with others in the development of the product safety
profileo Collaborates with others in development of clinical
sections of investigator brochures, presentations and other
materialso May participate in the identification and selection of
appropriate external investigators and siteso May assist others
with patient registry design and development (including strategies
for patient registry recruitment)o Collaborates with others in
development of study analytics and data management planso
Participates in investigator and other external presentations,
meetings and other communicationso May support clinical operations,
clinical research organizations (CROs), etc. by acting as a
point-of-contact for questions, other communications, and
interactionso Acts as a medical monitor for assigned studieso
Conducts ongoing reviews of medical/safety datao Collaborates with
relevant teams and other groups to measure and monitor study
progress against objectivesand plans, including any variances, and
proactively communicate any issues, challenges and potential
strategies to resolve sucho Supports, as needed, completion of
interim study reportingo Works closely with other CST members and
clinical operations to close-out clinical studies, secure data and
complete study reportingo Reviews study data to ensure correct
medical/scientific data interpretation for interim and final study
reportingo Participates in the development and implementation of
communications strategies to support existing and concluded
studies. Includes KOL interactions, advisory boards, major medical
meetings, congresses and other events, publications and other
materialso Works with other CST members, regulatory and other
internal partners/stakeholders in the completion and submission of
regulatory filings and other regulatory documentation. Supports
others with clinical scienceinformation and input for regulatory
submissions and other regulatory processes. Includes developing
label and packaging language, etc.--- Develops presentations for
other CST members to deliver to convey the CD perspective and
provide updates on strategies, plans and other activities--- Works
with other CST members in ongoing data generation to address unmet
medical needs and identify new or extended CD studies or other
programs in the relevant therapeutic area of assignment---
Completes other special projects, as and when assigned, or
otherwise requested--- Consistently complies with all governing
laws, regulations, Roche Standard Operating Procedures (SOPs) and
other guidelinesSELECTION CRITERIA:Candidates for this position
should hold the following qualifications, have the following
experience, and be able to demonstrate the following abilities to
be considered as a suitable applicant. Please note that except
where specified as"preferred," or as a "plus," all points listed
below are considered minimum requirements.QUALIFICATIONS &
EXPERIENCE:--- M.D. with relevant medical training in oncology
required. M.D/PhD a plus--- 2 or more years pharma/biotech industry
experience OR is a recognized expert in the field--- 2 or more
years experience with clinical trials across Phase II - III drug
development--- Academic/teaching background is a plus--- Experience
working with the principles and techniques of data analysis,
interpretation and clinical relevance (e.g., ISS, ISE, competitor
data, etc.)--- Experience developing product and safety profiles---
Versed in medical aspects of GCP (Good Clinical Practice), ICH
(International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use),
FDA, EMEA, NICE and other relevantguidelines and
regulationsABILITIES:--- Has impeccable ethics. Demonstrates, or
proven abilities to demonstrate, Roche Values--- Outstanding
attention-to-detail--- Has working knowledge of the
multi-disciplinary functions involved in a company's drug
development process, e.g. clinical operations, biostatistics,
regulatory, commercial operations, etc.--- Excellent project
management skills: can prioritize multiple tasks and goals and
ensure the timely, on-target and within-budget accomplishment of
such--- Good interpersonal, verbal communication and influencing
skills; can influence without authority--- Strong written
communication skills--- Good business presentation skills; is
comfortable and effective when presenting to others, internally or
externally--- Good negotiation skills: knows how to complete
deliverables by working effectively with others internally and
externally--- Good judgment and decision-making skills; knows how
to make trade-off decisions while balancing ethics and efficacy---
Works well within teams and is effective in collaborating with
others internally and externally--- Ability to travel globally
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Keywords: Roche, Sacramento , Medical Director - GI Oncology, Healthcare , Sacramento, California
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