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TakedaPharmaceutical Nordics AB · 9 hours ago

Vice President CMC (Small Molecules and Oligonucleotides)

Boston, MA

Full-time

Hybrid

Director/Executive

$256K/yr - $402K/yr

20+ years exp

TakedaPharmaceutical Nordics AB is a leading company in the pharmaceutical sector, and they are seeking a Vice President of CMC to oversee their portfolio of small molecules and oligonucleotides. The role involves developing innovative strategies, managing regulatory conformance, and leading a team to drive the organization towards innovative approaches in drug development.

Pharmaceuticals

Responsibilities

Develop innovative strategies for the management of the development products

Develop processes, systems and build the infrastructure to assure regulatory conformance prospectively while also managing conformance retrospectively for the products in the post approval space

Manage the pipeline combination products, while bringing the current products to today’s standards

Represent CMC and GRA on key governance committees and play a critical role in driving the organization towards innovative approaches for adoption and registration of new technologies/molecules in the pipeline, such as small molecules, synthetic peptides and oligonucleotides - novel and delivery approaches that are unprecedented

Lead senior individuals with varying backgrounds and will need to enable them to hire, mentor, and develop capable individuals who can represent the organization internally and externally on critical topics

Wear multiple hats as the role will involve complex interactions dealing with ambiguity and leading effectively in an uncertain environment will be a core competency

Single point of contact with key leaders at Takeda (GRA, R&D, GMS, GQ): This individual will serve as the key point of contact on Small Molecules and Oligonucleotides interfacing with: Research – to enable the fast prosecution of the portfolio and support the adoption of novel in-silico approaches

GMS – serve as the GRA representative on Small Molecules and Oncology Operations Leadership team to maintain the product licenses globally through proactive management of changes while also addressing the conformance challenges on legacy portfolio

GQ- Serve as the GRA representative on the Small Molecule quality council and in collaboration with head of Small Molecule and Oncology quality, enable proactive approaches to quality/compliance

GRA LT /Commercial/GPT: Engage with GRA therapeutic area heads as well as GPT’s/commercial teams and pharm sciences proactively to advance innovation using risk based principles and informed decision making as the core

Leadership: The individual will need to manage ambiguity and should have the ability to lead and guide the teams in situations of high stress where the stakes are high

He/she will need to lead the team and manage change, while not impacting current work and timelines

The ability to assess situations and resolve them using risk-based approaches would be a critical attribute

Communication: Ability to communicate concisely and clearly across all levels of the organization including stakeholders in R&D, GMS, GQ and Commercial

Ability to take complex issues and communicate them in a simple and understandable manner

Qualification

Regulatory Sciences LeadershipInternational Regulations KnowledgeTechnical Development ExperienceAdvanced Degree in Life SciencesFluent in EnglishCommunication SkillsCollaboration SkillsNegotiation SkillsProblem Solving SkillsInterpersonal Skills

Required

Advanced Degree or PhD in Life Sciences, Pharmacy or Medicines, or related discipline

Fluent in English (oral and written); additional languages desirable

Minimum of 20 years of experience within regulatory agencies or the Pharmaceutical Industry including significant leadership experience in Regulatory Sciences

Significant understanding and track record in dealing with international regulations and policies setting processes of major regulatory agencies (e.g. US FDA, EU, PMDA, NMPA, WHO)

Actively engaged in major industry associations (e.g. EFPIA, PhRMA, AAPS, PDA, ISPE, DIA) and joint regulator/industry initiatives (e.g. ICH)

Strong communication, collaboration, negotiation, problem solving and interpersonal skills

Ability to relate to stakeholders internally and also interface with external stakeholders (regulatory authorities), with the intent of enabling Takeda's success and positions that are science and risk based

High organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in teams

Desired technical skills: Experience in technical development, manufacturing and/or testing of pharmaceuticals