Vice President CMC (Small Molecules and Oligonucleotides)

Takeda Pharmaceutical Company•Cambridge, MA

6d•Hybrid

About The Position

Objective / Purpose: This role supervises activities that includes entire Takeda portfolio for pharmaceuticals including synthetic small molecules, synthetic peptides and synthetic oligonucleotides. The individual in this role will collaborate with Executives (VP/SVP) in R D (Discovery and Therapeutic area units - TAUs), GRA, GMS, Global Quality and Commercial. Accountabilities: 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. This will be a critical success factor for this individual and is a challenging task due to the varying nature of talent available for these modalities. 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.

Requirements

Advanced Degree or PhD in Life Sciences, Pharmacy or Medicines, or related discipline.
Languages: 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.
Has a proven track record of working across regulator/industry boundaries to find common solutions and drive positive impact and benefits for patients.
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.

Nice To Haves

Experience in technical development, manufacturing and/or testing of 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.
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.
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.
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.

Benefits

U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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