Associate Director, CMC Dossier Strategy and Leadership

About the role

Leads global regulatory dossier preparation activities for novel synthetic molecules by coordinating cross-functional teams of subject matter experts, from internal and external third parties. The primary function is to ensure consistent preparation of CMC regulatory submission documents of high scientific and technical quality that are compliant with global regulatory requirements.

Implement well-defined, efficient processes for preparation, review and approval of these CMC sections. Plays a critical role in ensuring that the CMC submission strategy is aligned closely with the clinical/regulatory development strategy and provides drug development experience and advice to the CMC team.

Influences development of new regulatory guidance, assure timely impact assessment, and implementation of new regulatory requirements.

Responsibilities

• Author and coordinate submission documentation for all phases of clinical development of synthetic molecules, with emphasis on later phase programs and marketing applications, often under significant time pressure. Drive team resolution and author responses to questions from regulatory authorities.
• Leverage extensive drug development experience to lead the global cross-functional CMC Team in completion of global regulatory submission documents. Maintain awareness of global regulatory requirements on pharmaceutical development. Ensure necessary changes to regulations are implemented in local practices and procedures.
• Demonstrate excellent interpersonal skills, ability to develop important relationships with external collaboration partners and key internal stakeholders. Demonstrate strong negotiating, influencing, and leadership skills.
• Develop standard processes and lead CMC project teams in planning, preparation, review and approval of sections of CMC submission documentation. Develop and maintain submission document templates for CMC regulatory documents in collaboration with CMC Regulatory.
• Embedded in the CMC team throughout development to collaborate on control strategy development and the planning of the data packages that will support the strategies.
• Participates in benchmarking activities to gather insights in industry trends and identify & implement opportunities ensuring control strategies are up-to-date.
• Independently identifies opportunities for improvement of departmental work processes and contributes to cross-functional process improvement projects.
• Actively facilitate the establishment of high performing teams. May mentor/supervise a team of one or more dossier authors and guide and evaluate the performance of those individuals.

Qualifications & Requirements

• Bachelor's with 12, Masters with 10, or PhD with 7 years of CMC functional experience including late-stage development experience
• 2+ years of leadership experience managing a team of technical professionals.
• Interdisciplinary CMC experience required.
• Prior experience in a relevant laboratory-based CMC function (chemistry, analytical, formulation, etc) translating experimental work into at-scale drug substance or drug product manufacturing.
• Excellent scientific writing skills including contributions to INDs and/or marketing applications and knowledge of regulatory requirements.
• Strong communication skills, written and verbal, with a demonstrated ability to summarize and communicate findings in a timely and efficient manner.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.