Anti-Infectives Portfolio Head - Clinician (MD)
Location:
Groton , Connecticut
Posted:
March 13, 2017
Reference:
1042711


About the company
A career at the company offers opportunity, ownership and impact.

All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
• Serves as a single point of accountability to the company Essential Health (PEH) business unit (BU) for clinical deliverables involving anti-infective products.

• Serves as single point of accountability as liaison to NGO and Governmental entities (eg BARDA, IMI, FDA, EMA, etc) and on joint steering committees with business partners (eg Allergan, Astra Zeneca) involved in development of new products for anti-microbial resistance. Co-leads with Commercial Anti-Infectives Portfolio Segment Team (PST), governance for anti-infectives assets.

• Oversees and approves regulatory submission documents for anti-infectives drug candidates

• Ensures appropriate medical and scientific expertise is brought to the clinical trial design, execution and interpretation of data, study reports, and clinical safety.

• Performs clinical trial safety review in role of Physician-Clinician (medical monitor).

• Assures that clinical trial objectives fit with the clinical program strategy.

Responsibilities
Clinical Development- including but not limited to:

• Point of accountability for portfolio of new and mature anti-infective products within PEH

• Serves as the company representative to external steering committees and governance bodies including interactions with BARDA, IMI, and joint development committee with business partners (eg Allergan, Astra Zeneca). Co-Leads with Commercial the Anti-Infectives Portfolio Segment Team (PST) to provide governance oversight of assets.

• Point of accountability to the Business Unit for design, execution, monitoring, delivery and reporting of one or more clinical development programs for regulatory submissions (or elements of those programs). Reports to Clinical Affairs Lead and functionally reports to Chief Medical Officer of PEH.

• Provides medical and scientific expertise to the clinical trial strategy and development process, including acquisition of knowledge of competitor products.

• Ensures the most efficient clinical protocols are developed through the application of enhanced trial design.

• Oversees Clinical Leads in their role developing and designing strategy, clinical plans, and protocols for drug development. The responsibility includes oversight of study management and medical monitoring of safety in clinical studies so as to meet goals in a timely, high quality and cost effective manner.

• Oversees Clinical Leads to ensure high quality of data, e.g. appropriate patient population, adequacy of clinical assessments etc.
Ensures and oversees delivery of clinical study Clinical Development- including but not limited to:

Point of accountability for portfolio of new and mature anti-infective products within PEH

• Serves as the company representative to external steering committees and governance bodies including interactions with BARDA, IMI, and joint development committee with business partners (eg Allergan, Astra Zeneca). Co-Leads with Commercial the Anti-Infectives Portfolio Segment Team (PST) to provide governance oversight of assets.

• Point of accountability to the Business Unit for design, execution, monitoring, delivery and reporting of one or more clinical development programs for regulatory submissions (or elements of those programs). Reports to Clinical Affairs Lead and functionally reports to Chief Medical Officer of PEH.

• Provides medical and scientific expertise to the clinical trial strategy and development process, including acquisition of knowledge of competitor products.

• Ensures the most efficient clinical protocols are developed through the application of enhanced trial design.

• Oversees Clinical Leads in their role developing reports signed off by the Clinical Leads; accountable for overall quality and timeliness of analysis and reporting.

• Assists in ensuring regulatory compliance for clinical trials and reporting.

• Presents to internal and external advisory committees (e.g. TRC, advisory boards) on design of clinical trials and data from clinical trials.

• Leads or oversees discussions with regulators and with the resolution of queries from drug regulatory agencies / ethics committees; leads or contributes to writing and review responses to regulatory queries.

• Oversees the preparation of the clinical content of regulatory submissions/documents (e.g. NDA, MAA, IND, sNDA, IB, AR).

• May support technical review of licensing opportunities, including due diligence activities.

As a Physician Clinician

• In addition to above duties, medically qualified clinicians may assume the role of physician clinician in oversight of non-medically qualified clinicians. Specific duties that require medical oversight include IB review, protocol review, safety review and clinical study report review. In addition, a physician clinician must be available for medical questions from investigators when required.

General

• Motivates and engages colleagues to facilitate an understanding of disease and foster team commitment to support an indication and mechanism.

• Coaches and mentors less experienced clinicians.

• Maintains and enhances knowledge in relevant disease area and/or technical area and practice guidelines relevant to the regions in which clinical trials are being conducted.

• Facilitates sharing of information on technical or operational best practices and lessons learned across Clinical Affairs.

Qualifications
• MD, DO or equivalent (required). Demonstrated clinical/medical, administrative, and organizational and project management capabilities are required, as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the company.

• Postgraduate training in medical specialty of infectious diseases or equivalent.

• Required: 10 years' experience in Phase 2-4 clinical development in the pharmaceutical industry, practical experience in clinical trial strategies, methods and processes.

• Required: Anti-infectives' experience in Phase 2-4 clinical trials

• Previous leadership/management experience or training (required).

• Thorough understanding of local and international regulations applicable to clinical development.

• Track record of design, oversight and interpretation of clinical studies.

• Demonstrated scientific productivity (e .g. doctoral thesis, publications, research reports, etc).

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Ability to travel 25% (international and domestic).

Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.

EEO & Employment Eligibility
the company 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. the company 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. the company is an E-Verify employer.

A little about us:
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