Associate Director CMC PM
Company: Regeneron Pharmaceuticals, Inc.
Posted on: May 12, 2022
We are currently looking to fill an Associate Director CMC PM
position. Using extensive CMC Project Management knowledge and
experience in the drug development industry, the AD provides
operational leadership, direction and support to CMC-PM team
members. Individual may also manage CMC Projects that are generally
of sophisticated complexity and large scope (such as Commercial or
Late Clinical Phase in nature). As a leader the individual
consistently demonstrates strong interpersonal skills and
consistently cultivates productive relationships with internal and
external customers. The AD provides experienced guidance and
mentorship with regards to CMC-PM to team membersIn this role, a
typical day might include the following:
- Facilitates achievement of strategic project milestones and
supports, through active and consistent leadership, department
operational objectives. Monitors ongoing progress of key
deliverables against global development plan milestones, including
the identification of potential risks and contingency plans. Acts
as a key resource for direct reports on matters related to CMC
- Acts as a key liaison in the interactions between Regeneron and
our corporate partners. Prepares, provides input, and / or manages
the process involving major presentations for joint collaboration
meetings - effecting key business decisions. Responsible for
facilitating and driving decision making in support of the joint
strategic objectives of the program.
- Supports and Implements the standardization of processes and
communication tools in order to build efficiencies within the
- Exhibits a degree of ingenuity, creativity and resourcefulness
in a sometimes evolving and ambiguous environment. Shows resiliency
in the face of challenges and adversarial situations. Exhibits
confidence and a realistic sense of self awareness in own strengths
- Develops an integrated CMC Project plan relevant to the team
deliverables and ensures alignment across relevant functions and
smooth transitions among pipeline stages. Leads annual goal setting
sessions to develop CMC Project level achievements that chip in to
the overall achievements and for monitoring progress against these
goals. Plans contingency and risk mitigation planning. Oversees the
development of integrated CMC Project plans and actively monitors
progress against the approved baselines.
- Demonstrates the ability to gain collaboration of others and
effectively facilitates the resolution of cross-functional issues.
Ensures effective, accurate and timely communication across
functional areas within the CMC Project, serving as a primary point
of contact for management within and outside the team regarding
progress on CMC Project achievements. Communication
responsibilities include but not limited to Manage Supply,
weekly/monthly project updates as well as TMPs. Works with the team
leader to identify and resolve any team and individual performance
issues. Together with Department Director identifies and resolves
any team and/or individual performance issues.
- Develops COMPASS key deliverables and CMC Project dossier
items. Identifies and implements new solutions to improve tracking,
planning and collaboration.
- Coordinates and leads communication between global functional
areas and corporate partners where applicable. Coordinates
activities for writing data summaries or presentations for joint
collaboration meetings, etc.
- Proactively identifies issues and provides solutions to resolve
CMC Project issues and develops solutions to meet productivity and
quality achievements and objectives.
- Develops tools and mechanisms for supervising progress and
problem solving with CMC Project and functional area managers.
Defines and documents working / standard methodologies that can be
used across other CMC Projects with all relevant departments in
order to ensure that product is efficiently supplied to all
non-clinical, clinical, and commercial sites
- Regularly interacts with Sr. Management or executive levels on
matters concerning several functional areas. Requires the ability
to change the thinking of, or gain acceptance of others in
sensitive situations and influences the overall objectives and
long-range achievements of the CMC Project / program. Represents
the department in relevant internal / external committees.
Coordinate the CMC regulatory activities required for submission of
license applications, INDs, and other regulatory documents to
government agencies. Adept at managing multiple projects/tasks
simultaneously, switching between tasks quickly, and juggling
competing priorities and projects.
- Lead special projects as assigned by the Department
Director/Sr. DirectorThis role might be for you if:
- Possess excellent written, verbal and interpersonal skills and
the ability to effectively interact with all levels both within and
outside the company to establish credibility with professionals on
the CMC program teams.
- Excel at resolving and mitigating conflicts or problems with
tact, subtlety and composure.
- Enjoy balancing multiple CMC projects and priorities with
outstanding organizational and time management skills (both CMC
project and self).To be considered for this role you must hold:
Bachelors, Masters or Doctorate in any physical or Biological
Science. 10+ years (with BA/BS), 8+ years (with MA/MS or Ph.D) of
relevant progressive CMC Project Management experience. Experience
successfully leading a team in the drug development industry.Does
this sound like you? Apply now to take your first steps toward
living the Regeneron Way! We have an inclusive and diverse culture
that provides amazing benefits including health and wellness
programs, fitness centers and stock for employees at all
levels!Regeneron is an equal opportunity employer and all qualified
applicants will receive consideration for employment without regard
to race, color, religion or belief (or lack thereof), sex,
nationality, national or ethnic origin, civil status, age,
citizenship status, membership of the Traveler community, sexual
orientation, disability, genetic information, familial status,
marital or registered civil partnership status, pregnancy or
maternity status, gender identity, gender reassignment, military or
veteran status, or any other protected characteristic in accordance
with applicable laws and regulations. We will ensure that
individuals with disabilities are provided reasonable
accommodations to participate in the job application process.
Please contact us to discuss any accommodations you think you may
Keywords: Regeneron Pharmaceuticals, Inc., Troy , Associate Director CMC PM, Executive , Troy, New York
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