Pfizer

Senior Director, Drug Product Design

Employer
Pfizer
Location
Groton, Connecticut
Salary
Competitive
Posted
June 18 2021
Ref
4815941
Discipline
Other, Other
Position Type
Full Time
Organization Type
Pharma
The Senior Director of Biopharmaceutics is a global team head within Drug Product Design (DPD) Department of Pharmaceutical Science. The Senior Director is a member of the strategic Leadership Team of DPD and plays a key role in maintaining end-to-end connectivity from early research, full development and post-launch biopharmaceutics needs for the small molecule portfolio. The Senior Director will be responsible for the oversight of the global Biopharmaceutics Group of about ~25 people with members located in Sandwich UK, Groton CT and the three US research sites. The candidate will collaborate, liaise and nurture networks with research site principals and global heads in Medicine Design, Drug Metabolism, Drug Safety, Clinical Pharmacology, Pharmaceutical Sciences and other disciplines e.g. Pfizer Global Supply to support accelerated development, advance model informed drug development and enable successful regulatory outcomes resulting from implementation of impactful biopharmaceutics strategies. The Senior Director will be accountable for developing and delivering end-to-end biopharmaceutics strategy for the portfolio.

This colleagues is accountable for supporting the personal growth of staff as well as providing scientific direction and operational oversight of global Biopharmaceutics Group. The candidate will manage an existing team of scientists and develop the team through goal setting, performance management and personal development planning. The candidate will hire and grow biopharmaceutics talent. The candidate will be a champion for the advancement of translational biopharmaceutics and physiologically based pharmacokinetic modelling for biopharmaceutics applications. The candidate ensures that the Biopharmaceutics Group contributes to regulatory submissions including PBPK model supported specifications for drug product. The candidate will liaise with allied disciplines to develop integrated biopharmaceutics strategy to enable development of drug product specifications that are consistent with manufacturing process understanding and control.

The candidate is a member of key global governance and advisory bodies. The Senior Director has experience in understanding and addressing opportunities and risks associated with oral absorption and biopharmaceutics risks of small molecules in support of preclinical, toxicological, clinical testing and the design and development of drug products. Provides strategic biopharmaceutics direction with the design and development of oral immediate release and modified release products, topical and parenteral drug products; and progression of novel drug delivery technologies to serve the needs of current and future portfolio. The candidate understands risk assessment and risk mitigation strategies necessary to establish connectivity between bioperformance and manufacturing processes as well as stability of drug product through all stages of development. The Senior Director will develop strategic plans for future growth and will participate in ideation, development, and implementation of drug delivery strategy for preclinical and clinical testing of small molecules. The candidate provides insights into the strategic direction of the global biopharmaceutics group by evaluating trends, future needs, and feedback from key partners. The candidate will liaise globally with Drug Product Design colleagues to enable development of new drug products with an end-to-end biopharmaceutics strategy from early clinical studies through to regulatory filing and commercial application.

The candidate will be a highly recognized external global biopharma leader and be a key influencer across all aspects of biopharmaceutics through Professional bodies, establishing external research collaborations/consortia, publications and keynote addresses.

Role Responsibilities
  • Cultivates sustainable and effective relationships with partners and stakeholders globally including at the research sites, i.e. partner lines in Medicine Design, Drug Metabolism, Drug Safety, Clinical Pharmacology, Pharmacokinetic, Pharmaceutical Sciences, Research Unit and Business unit principals, etc.
  • Enables seamless collaboration within Biopharmaceutics team members and team principals across all Drug Product Design sites to ensure alignment and shared learning from the development of portfolio projects and new technologies.
  • Build collaborative relationships, communicates well to influence within a matrix environment, with senior leaders across the wider Medicinal Sciences, Drug Product Design and Pharmaceutical Sciences Small Molecule organizations.
  • Manages a team of Group directors and their staff along with senior scientists within the global Biopharmaceutics Group. The group size is ~25 in total.
  • Provides strategic guidance and direction for direct reports, managing resource capacity along with prioritizing workload appropriately, ensuring budgetary targets are met
  • Enables development of talent, succession planning and personal development of direct reports as well as for the entire staff of Biopharmaceutics group across all three research sites.
  • Has direct accountability for setting strategic direction, deploying resources, performance assessment, goal setting, and development discussions for the Biopharmaceutics team members globally.
  • Takes appropriate business risks to achieve desired results, ensuring safety and project delivery during all stages of development.
  • Enables or provides strategic direction for new experimental methodologies and new technologies and/or utilization of computational predictive tools to address future needs.
  • Is a member of the DPD senior management team and contributes to the strategic direction and delivery of the DPD departmental goals.
  • Is a member of global governance and advisory bodies such as Biopharmaceutics Advisory Team, Biopharmaceutics Steering Council, Biowaiver Advisory Council, Dissolution Advisory Council etc.
  • Leads the group through change, ambiguity and without all the information needed. Seeks continuous improvement for self and responds to changes in both internal and external environment
  • Leads the conversation through an excellent external profile and is a recognized authority in the field.


Basic Qualifications
  • Advanced degree (PhD) or equivalent in Biopharmaceutics, Pharmaceutics, Clinical Pharmacology, Pharmaceutical Chemistry, Chemistry, Analytical Chemistry, Physical Chemistry, Chemical Engineering or Life Sciences and 15 years of experience in pharmaceutical industry.
  • BSc/MSc in Pharmaceutics, Chemistry or related discipline with a minimum of 20 years relevant pharmaceutical industry experience in small molecule drug molecule selection and drug product design.
  • Technical and people management experience in supporting all staged of drug discovery, development, and successful registration of new medicines.
  • Experience leading and collaborating with multifunctional, multi-disciplinary teams and working across matrixed cross site and global teams.
  • Track record of supporting creativity, innovation and development of new capabilities.


Technical Skills
  • Knowledge and experience about holistically implementing biopharmaceutics strategies for drug discovery, selection of molecules for development, design of formulations, for pre-clinical and clinical testing of small molecules, developing biopharm control strategies and regulatory filings.
  • Experience and expertise in the whole drug product development process and successfully guided teams at all stages of drug development
  • Ability to communicate and engage with key stakeholders to anticipate and address drug delivery and regulatory needs for the future portfolio
  • Delivered innovative solutions that have made significant impact to the understanding and/or predicting biopharm risk, performance and control


Leadership Skills
  • Nurture and cultivate global peer networks with Pharmaceutical Sciences, Med Design, Drug Safety, Clin Pharm site and key stakeholders
  • Be recognized externally as global collaborative leader in the Biopharm Discipline
  • Ability to partner, mentor and manage a group of scientists across multiple sites, managed situations of ambiguity, work across matrixed cross site and global teams
  • Accountability for making day-to-day and strategic decisions
  • Committed to personal development and scientific growth of all staff
  • A proven track record in identifying, recruiting development of diverse biopharm talent.
  • Thoughtful and inclusive decision making and whose opinions and recommendations are valued by peers, senior management, governance and advisory bodies.
  • Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.


Preferred Qualifications
  • Knowledge, experience and understanding of all aspects of the end-to-end influence of biopharmaceutics in the drug development and registration process. Be a leader or member of key professional, consortia or academic bodies that influence the global biopharm scientific or regulatory direction
  • A strong academics track record of publications and key note talks at influential professional meetings


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • Travel to global DPD sites for management meetings as well as attending national and international conferences and professional bodies
  • Cross site working and communication via virtual meetings, Team environments, email and instant messaging are the norm and facilitates a flexible on and offsite working environment for the selected individual


Additional Job Information
  • Last date to apply: June 30, 2021
  • Eligible for employee referral program
  • Relocation support available
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Sunshine Act

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EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Research and Development

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