Senior Medical Director, Medical Development
Location: San Diego
Posted on: September 23, 2022
This position is responsible for the design, plan and execution of
clinical trials, and running of programs focused on assigned
therapeutic areas, in accordance with applicable regulatory and
quality standards, and company timelines and budgets. Activities
are geared toward ensuring that all clinical activities related to
clinical trials are managed effectively in support of regulatory
submissions and subsequent approval.
- Lead the development and execution of clinical plans to drive
programs through clinical studies. Identify needs, contingencies
and operational plans, while also ensuring strategic positioning is
in line with company goals.
- Lead the clinical development team, in close collaboration with
all involved line functions such as operations, regulatory etc., of
designated clinical studies.
- Provide strategic input on new indications and/or opportunities
for antibodies already in development as well as for novel
antibodies entering the clinic
- Work closely with the discovery team helping in the
identification of novel targets
- Write and/or facilitate the writing of clinical project
management documents such as project scope definition documents,
project training materials, monitoring plans and monitoring tools,
study protocols, safety plans, recruitment plans and closeout
- Coordinate/execute operational aspects of assigned clinical
studies (including identification, selection, qualification and
management of clinical investigators and third party vendors, test
article release to sites, site monitoring activities, ongoing
review of key study data, etc.).
- Review and approve monitoring reports and follow-up letters
prepared by the project CRAs for assigned studies.
- Plan and review the analysis of clinical data and determine the
ultimate interpretation of results.
- Ensure the assigned trials are "audit ready" at all times
(project team training records, current regulatory documents,
appropriate IRB approvals, monitoring tools required for the
trial). Ensure that any audit observations are addressed
appropriately and in a timely manner.
- Develop and maintain project schedules, with key metrics, for
clinical projects to ensure optimal study management. Identify and
resolve issues that impact project scope, resources. or timelines
and communicate to senior management.
- Develop and monitor overall clinical development budget for
assigned projects; effectively manage resources, funding and
- Assist with tracking and forecasting resource capacity and
utilization to ensure that required clinical development resources
are available when needed and optimally utilized.
- Provide therapy area medical and scientific expertise to study
teams and key stakeholders.
- Anticipate trends in medicine and industry that may/will have
an impact on the clinical/commercial viability of products and
factors into planning.
- Serve as principal medical monitor overseeing all aspects of
the safety monitoring in the clinical development programs.
- Prepare clinical sections of regulatory documents such as
investigator brochures, INDs, NDAs, BLAs, background packages for
FDA meetings, etc. Provide medical review and approval of
regulatory documents pertaining to the work of the clinical
- Cultivate and nurture strong collaborations with key opinion
leaders, Investigators, research centers and corporate
- Collaborate with Business Development, Senior R&D and
Commercial leadership to identify, recommend and develop strategic
alliances, partnership and licensing opportunities requiring due
diligence work and strategic input.
- Engage and inspire the project/clinical development team
through communicating the strategic vision and the operational plan
to achieve the vision.
May manage other employees in the Clinical Development Department;
would be responsible for the overall direction, coordination, and
evaluation of these employees, carrying out supervisory
responsibilities in accordance with the organization's policies and
applicable laws. Duties would include interviewing, hiring, and
training employees; planning, assigning, and directing work;
appraising performance; rewarding and disciplining employees;
addressing complaints and resolving problems.
Education and Experience:
- MD and US medical license, with 14+ years of clinical drug
development related experience in the research and development of
novel biologics, particularly within the field of
- Expertise in preclinical, translational and early clinical
development within the field of inflammation
- Extensive academic and pharma collaborative network. History of
personal interaction with thought leaders in the inflammation
- Track record of program leadership and achievement of goals and
deliverables, of effective collaboration, effectiveness in team
settings, and team leadership
- Experience with Microsoft Word, Excel, PowerPoint, Outlook,
Adobe, and Internet Explorer.
- Firm understanding of the mechanistic basis of human
- Thorough understanding of clinical protocols and regulatory
- Excellent understanding of the drug development process
- Thorough knowledge of FDA requirements, Good Clinical
Practices, and pharmaceutical clinical development.
- Demonstrated success establishing, communicating and driving a
vision and strategy for a therapeutic area/product, and develop an
integrated plan of action including milestones and endpoints and
ensure executional excellence.
- Viewed as a leader within the therapeutic area/disease state
and considered a scientific contributor and innovator within
internal and external spheres of influence.
- The ability to think globally, strategically and innovatively
about the future of the disease state and company's therapeutic
agents and possess a solid understanding of the pharmaceutical
industry, company competition and commercial side of business,
including Marketing and Sales, Market Access,
Pricing/Reimbursement, Business Development, Medical Affairs and
- Effective communication and interpersonal skills, with the
ability to successfully articulate strategies, experimental results
and analysis to various constituents such as governance committees,
project teams, clinical sub-teams, and other senior management to
build enthusiasm, passion and commitment, and to gain approval
/sponsorship for projects. Speaks clearly and persuasively in
positive or negative situations; Listens and seeks clarification;
Responds well to questions; Demonstrates group presentation skills;
Participates in meetings. Ability to respond effectively to the
most sensitive inquiries or complaints.
- Ability to work effectively in as a team player in a complex,
changing environment, intensely committed to success and getting
the job done well, with the additional ability of being able to
build morale and group commitments to goals and objectives;
- Ability to garner support for projects and recommendations
through on-going collaboration, open and influential communications
and commitment to improvement/change.
- Ability to work productively in a matrix team environment, as
well as take ownership of multiple projects.
- Ability to define issues, collect and analyze complex data, and
draw valid conclusions.
- Handle obstacles and roadblocks by anticipating challenges and
preparing well thought out arguments and contingencies.
Ability to develop strategies to achieve organizational goals;
demonstrates an understanding of organization's situation and
goals; analyzes market and competition; identifies threats and
opportunities; adapts strategy to changing conditions.
- Displays willingness to make decisions; Exhibits sound and
accurate judgment; Supports and explains reasoning for decisions;
Includes appropriate people in decision-making process; Makes
- Innovation - Displays original thinking and creativity; Meets
challenges with resourcefulness; Generates suggestions for
improving work; Develops innovative approaches and ideas; Presents
ideas and information in a manner that gets others' attention.
The physical demands described here are representative of those
that must be met by an employee to successfully perform the
essential functions of this job. Reasonable accommodations may be
made to enable individuals with disabilities to perform the
While performing the duties of this job, the employee is regularly
required to sit and talk or hear. The employee frequently is
required to use hands to finger, handle, or feel. The employee is
occasionally required to stand, walk, and reach with hands and
arms. The employee must occasionally lift and/or move up to 10
pounds. Specific vision abilities required by this job include
close vision and ability to adjust focus in order to read.
The work environment characteristics are representative of those an
employee encounters while performing the essential functions of
this job, typically in an office environment. Reasonable
accommodations may be made to enable individuals with disabilities
to perform the essential functions.
The noise level in the work environment is usually moderate.
May be required to travel by plane domestically and internationally
about 20% of the time
All qualified applicants will receive consideration for employment
without regard to race, color, sex, sexual orientation, gender
identity, religion, national origin, disability, veteran status,
age, marital status, pregnancy, genetic information, or other
legally protected status.
Keywords: AnaptysBio, San Diego , Senior Medical Director, Medical Development, Executive , San Diego, California
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