Associate Director, External CMC In-License and M&A Diligence

Job description

Nombre del sítio: USA - Pennsylvania - Upper Providence, USA - Massachusetts - Waltham, USA - North Carolina - Research Triangle Park
Fecha de publicación: Feb 7 2024

Are you interested in a matrix leadership role with high visibility that supports building GSK’s portfolio of innovative products through in-licensing, partnerships, acquisitions and divestments? This opportunity will allow you to operate in a fast paced environment where you can put your CMC development and manufacturing expertise to work in a high-performance cross-functional matrix team to conduct technical CMC-related due diligence for small molecules, large molecules and oligonucleotide assets. 

If so, the Associate Director, External CMC In-License and M&A Diligence is an exciting role for you to consider.  The successful individual will join the Medicine Development & Supply (MDS) Scientific Licensing and External CMC Diligence team which has enterprise accountability for CMC input into all stages of the due diligence process including contracting for in-licensing, co-development/co-commercialization, Mergers & Acquisitions (M&A) and divestments.

Key Responsibilities:

·  Lead operational aspects for full-diligences to ensure a harmonized approach is being taken to meet the overall expectations of the diligence process. Works closely with the CMC diligence lead to drive completion of the diligence outputs (e.g. risk register, diligence report etc.) upon agreed timelines. Identifies opportunities across multiple diligences for continuous improvement of the diligence process.
·  Lead the development and continuous improvement of the overall due diligence workflow and post-deal implementation steps of the CMC aspects to enable integration of the project into the GSK portfolio.
·  Supports post-deal activities including knowledge transfer from the CMC Diligence Team to the CMC Project Matrix team, collaboration with IT (Tech), Alliance Management and Risk Management & Compliance to documents/knowledge are transferred into the GSK ecosystem.
·  This role requires negotiation, enrolling, aligning, facilitating risk management  conversations etc. with the appropriate stakeholders to ensure that all the CMC-related aspects are appropriately captured in the contractual agreements as part of the overall diligence process
·  Fosters a team culture of ownership and accountability.
·  Some travel may be required.

Skills & Competencies:

·  Experience in CMC medicine development, particularly late stage and preferably through to successful product approval and launch
·  Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of confidentiality.
·  Clear presentation skills and ability to articulate technical/business drivers at all levels in the organization
·  Ability to influence at fairly senior levels in the business and across multiple disciplines
·  Collaborative, cooperative, inclusive and transparent, builds and cultivates high performing teams and partnerships
·  Ability to balance scientific, technical and manufacturing risks against the overall business impact
·  Understands the business financial context within which decisions are made

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

·  BS degree with 8+ years, or MS degree with 6+ years of relevant experience which includes pre-clinical drug development or biopharmaceutical manufacturing in a technical role.
·  Experience working in a business alliance environment.
·  1+ year of experience of leadership in a matrix environment as a CMC lead (e.g. drug substance lead, drug product lead or analytical lead) to create and defend CMC development strategy, plan and data package for a small molecule, large molecule or oligonucleotide product.
·  Experience in business aspects of contracting (e.g. collaboration/partnership agreements, CDMO contracts etc.)  

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

·  PhD degree in chemical/biochemical engineering, chemistry, biology, biochemistry, or related technical discipline, or BS/MS degree with MBA
·  5+ years of pharmaceutical industry experience in sterile product manufacturing process development including mAbs, ADCs, small molecules, oligonucleotides or vaccines
·  Entrepreneurial mindset, willing to identify opportunities to add value to GSK and the various functions through improvements in the diligence and integration processes.
·  Demonstrated leadership skills in leading within a matrix environment, and the ability to work across various functional organizational interfaces.
·  Experience creating integrated CMC development & supply chain strategy, plan and data package for drug substance or drug product and successfully navigating these strategies with senior CMC stakeholders
·  Prior basic experience and understanding of contractual language with CDMOs or partner organizations
·  Working knowledge of early and late stage development activities associated with regulatory submissions (IND/IMPDs and NDA/BLA/MAA submissions) for both small and large molecules
·  Industry-tested problem solving and risk management skills.

Why GSK?

Our values and expectations   are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

·  Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
·  Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
·  Continuously looking for opportunities to learn, build skills and share learning.
·  Sustaining energy and well-being
·  Building strong relationships and collaboration, honest and open conversations.
·  Budgeting and cost-consciousness

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why Us?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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