Cmc Program Manager Jobs in Ohio (NOW HIRING)

This is what you will do:

The Executive Director, Global Program Team Lead is responsible for providing strategic direction and leading the global drug development for one or multiple Global Program Teams with complex Phase III clinical development programs. Typically, a GPT Lead would conduct their GPT work as part of a GMT and under the supervision of a GMT Lead (except for medicines with only one indication).

As the accountable program(s) owner/CEO, the Global Program Team Leader (GPTL), leads and chairs the Global Program Team (GPT), leading the creation of an integrated development plan, maintaining a strategic focus and ensuring the GPT's commitments are met.

The GPTLs role is one of leadership, being proactive and interactive, and emphasizing partnership with all GPT members and other stakeholders and consultants both within and outside R&D. The GPTL should stimulate creative and productive discussion, motivate, ownership and urgency (when necessary) as well as robust discussions of risk identification and mitigation opportunities, and ensure clarity of purpose and responsibilities with the GPT. The GPTL has negotiation and persuasion skills necessary to ensure success of the program and sets goals for the GPT and specific program-related goals for the Core Team members. GPTLs are the "voice" of the GPT up the line (GMT Leadership, R&D and VISion Leadership, Development and Commercial Steering Committee and Executive Committee), and the principal liaison and partner to other groups.

In stand-alone programs for a medicine with only one indication (i.e., no GMT), the GPT is co-led by the R&D GPTL and a Commercial (VISion) Team GPTL.

You will be responsible for:

The GPTL is accountable for:

• Program ownership with final accountability for clear definitions of program goals, plans, decisions and deliverables to meet those goals

• Provides strategic direction and leadership of global development programs from Post-PoC to BLA/NDA/MAA for assigned projects in accordance with the global R&D strategy. Provides global development strategy and leadership for assigned projects to ensure clear goal setting and robust development plans for effective and efficient development. (This will entail working closely with core team members, functional leads, and other colleagues to collaborate and ensure their buy-in and knowledge-sharing in establishing and implement the global development strategy for assigned projects.)

• Ensures that the GPT implements its plans and adheres to key development milestones for assigned projects.

• Accountable for aspects of pre-clinical, CMC, clinical plans and programs across from Post-PoC through commercial approval for assigned projects.

• Leads the global project team and reviews development plans for assigned projects and thorough product lifecycle management for assigned projects.

• Contributes to objective setting and appraisal of core team members for program related activities

• Keeps senior management informed

• Is accountable for the program budget

• Ensures high performance team effectiveness

You will need to have:

• Advanced life-science degree (MD, PhD or PharmD) is preferable with a specialty in the assigned therapeutic area, or equivalent experience with global development required.

• Total leadership experience including line/project management, multidisciplinary program management experience, which includes leadership in more than one IND/IMPS, BLA/NDA/MAA, Advisory Committee or other PMDA/EMA/FDA meetings is desirable.

• Minimum of ten (10) years of experience in drug development in pharmaceuticals, biopharmaceuticals, or biotechnology.

• Demonstrated experience leading the development of at least one development candidate with adherence to quality, excellence and efficiency.

• Demonstrated experience leading drug development projects and activities in a matrixed, global organization.

• A broad understanding of how to communicate and work well with team members and relevant people as well as scientists and external decision-makers worldwide.

• A thorough understanding of how to influence local and global regulatory, scientific, and commercial environments.

• Ability to assimilate data, recognize key variables and analyze complex situations. Make quality judgments.

• Has a realistic expectation of the business, oneself, and others.

• A style which builds alliance within the organization, locally/globally, and/or corporate collaborators.

• Does not confuse effort for results.

• Tenacity to weather short-term setbacks for long-term advantages.

• Broad understanding of the multidisciplinary functions contributing to effective and efficient drug development.

• Solid understand of CMC, pharmacology, toxicology, PK, clinical requirements to support major regulatory filings - IND/IMPD, BLA/NDA/MAA

• Has experience leading preparation of PMDA/EMA/FDA milestone meetings, such as Pre-IND, EoP-1, EoP-2, Pre-BLA/NDA, Advisory Committees, focusing on the key strategic issues.

• Excellent understanding of the interdependencies of the various disciplines (e.g., CMC, Pharm/Tox, PK, Clinical, Regulatory, Marketing, Finance) - what needs to be evaluated simultaneously vs. sequentially etc. from a strategic planning/risk management time/event/cost point locally and globally.

• Has a firm understanding of how to educate/advise/operate with respect to Regulatory Guidance/Internal SOPs/Project best-practice behaviors.

• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

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