Executive Director, CMC Strategy & Portfolio Management

Harmony Biosciences is recruiting for an Executive Director, CMC Strategy & Portfolio Management. In this role you will be accountable for - and provides leadership to - interdisciplinary, matrix teams responsible for developing and executing product-specific integrated CMC strategies. The position is responsible for creating and formalizing the CMC Management group within Technical Operations, to drive R&D Franchise Team objectives and incorporate all CMC elements across drug substance, drug product, analytical, quality, regulatory CMC, and clinical/commercial supply.

Responsibilities include but are not limited to:

• Lead the CMC Strategy team, including building and mentoring a strong team of CMC leaders and Technical Development Program Leaders (TDPLs) for various assets in development
• Develop the framework and playbooks for CMC strategies, incorporating forward-thinking development plans, ensuring all necessary CMC activities will support registrational studies and commercial launch.
• Lead cross-functional CMC teams for late-stage (Ph3 and launch) programs, and oversee programs in earlier (pre-clinical through Ph2) stages of development
• Serve as the CMC "asset owner" with accountability to drive the creation and execution of Integrated 5-year CMC strategies and maintenance of 18-month rolling tactical project plans
• Represent CMC & Technical Operations on Franchise Teams and actively collaborate with other functions (Clinical, Commercial, Regulatory, Clinical Pharmacology, Toxicology, etc.) to achieve the best development and business results for the company.
• Collaborate with the Project Management Team, TDPLs, and Technical SMEs to manage key strategic vendor interactions for timelines, deliverables, and key milestones
• Communicate and partner effectively with all functional areas within CMC and Technical Operations, and other stakeholders (Quality, Pre-clinical Toxicology, Clinical Operations, Regulatory CMC, etc.) to define and execute CMC strategies aligned with Franchise Team Project Plans
• Partner with CMC Project Managers to identify and escalate key issues and risks as well as resource allocation needs, as appropriate
• Critically review relevant documents, including but not limited to all CMC regulatory submissions, briefing books, agency information requests, etc.
• Lead or contribute to continuous improvement initiatives across the organization
• Partner with the business development group to support or lead due diligence evaluations and activities associated with bringing in new assets in partnership with alliance management, as necessary

Qualifications:

• Bachelor's degree required within scientifically relevant field (Chemical Engineering, Chemistry, etc.); Advanced degree MS / PhD / MBA is strongly preferred
• 15+ years of relevant pharmaceutical industry experience required with a focus on CMC development and matrix management.
• Strategic and tactical project and team leadership experience
• Track record of effective matrix leadership experience in the setting of program teams across the full product life cycle, e.g., CMC, Tech Ops line functions, Quality, Regulatory CMC, sub-teams or other cross-functional teams operating in a matrix environment ideally across an organization
• Broad understanding of CMC, supply chain, DS and DP development, or LCM development extending from IND to NDA and global launch including a solid understanding of global registration processes. Technical expertise in a relevant pharmaceutical development discipline
• Experience in pharmaceutical industry with a demonstrated understanding of cross-functional interdependencies (i.e., R&D, commercial, technical development, regulatory CMC)
• Excellent strategic, business, organizational, and relationship development skills
• Demonstrated ability to lead, motivate, influence without authority a strategic direction; ability to effectively leverage and develop diverse perspectives and ideas from matrix teams and others.
• Excellent communication, negotiation, problem solving and decision-making abilities
• Demonstrated ability to identify critical program risks and develop mitigation plans - strategic or tactical to mitigate risk, costs, and reputation of Harmony's business

Physical demands and work environment:

• Travel (both domestic and international) is estimated to be 20% of the time for this position.
• Must be able to maintain / obtain a valid US Passport.
• While performing the duties of this job, the noise level in the work environment can vary from relatively quiet (office) to moderate (laboratory/manufacturing). Hearing protection will be required at times.
• Specific vision abilities required by this job include: close vision.
• Manual dexterity required to use computers, tablets, and cell phone.
• Continuous sitting for prolonged periods.

What can Harmony offer you?

• Medical, Vision and Dental benefits the first of the month following start date
• Generous paid time off and Company designated Holidays
• Company paid Disability benefits and Life Insurance coverage
• 401(k) Retirement Savings Plan
• Paid Parental leave
• Employee Stock Purchase Plan (ESPP)
• Company sponsored wellness programs
• Professional development initiatives and continuous learning opportunities
• A certified Great Place to Work for seven consecutive years based on our positive, values-based company culture

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Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, visit www.harmonybiosciences.com

Harmony Biosciences is an Equal Opportunity, e-Verify Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Recruitment agencies please note: Harmony Biosciences will only accept applications from agencies/business partners that have been invited to work on a specific role. Candidate Resumes/CV's submitted without permission or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.

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