Exec Med Dir, Global Product Development (Nephrology)

Company: PPD - Pharmaceutical Product Development
Location: Bethesda
Posted on: January 20, 2023

Job Description:

Exec Med Dir, Global Product Development (Nephrology)Bethesda MD - Bethesda - MDJob DescriptionThe GPD leadership role requires proven abilities to drive both strategic innovation and measurable business outcomes.
The incumbent's track record of therapeutic expertise will be extensive and ensure recognition of the incumbent as a peer of their Pharmaceutical Industry equivalents. -This position will play a key part in the future business success of PPD as it seeks to continue its track record of successful growth and expand its Industry leading position.
The role comprises four major functions.Responsible for ensuring the highest possible quality of input into significant requests for proposals (RFPs) including:Development strategy and regulatory issuesDrug class issuesProtocol and indication considerations, including safetyTeam education on indicationInteractions with client physicians and/or client Therapy Area leaders prior to or during bid defensesIdentifying business opportunities for PPDResponsible for supporting outstanding input into other areas of PPD's business activity including:Pro-active client engagement: peer-to-peer interaction with TA leaders and senior medical directors of companies whose product portfolio contains drugs of business interest to PPDStrategic alliance development & supportClient governance or advisory boardsThrough PPD's consulting practice, the incumbent will provide Industry gold standard product development plans, and top level design of clinical trial protocols that are required in the plan.Provide a supporting role in PPD's Therapeutic Area Strategic Team (TAST), a cross functional team charged with championing PPD's business development by creating focused solutions for client companies. Examples include:Identifying strategic client opportunitiesClient pipeline analysisIdentifying drug product opportunitiesPartner with business development to implement specific strategies to grow therapeutic area book of businessEvaluating and integrating PPD's service offerings, such as Phase 1 first in human testing capabilitiesClinical trial operations expertiseRegulatory intelligence expertiseLaboratory capabilities (including biomarkers)Imaging capabilitiesPost-approval studies and outcomes expertiseSpecial services - i.e. DSMB management, ARO partnershipResponsible for providing therapeutic and developmental expertise to internal PPD teams including:Indication-specific training for clinical teamsGuidance during clinical trial executionClinical data review and evaluationInvestigator brochure, clinical study report, NDA/MAA documents, and regulatory briefing documents review and editingContribute to design and reporting of feasibility studiesLiaise with investigators and KOLsMentor and supervise clinical scientists#LI-LC1Job QualificationKnowledge, Skills, and AbilitiesThorough understanding of overall biologic/pharmaceutical product development process, from pre-clinical through post-marketing, including all stages of development and all functional rolesExperience developing strategies to support first-time-in-human studies through marketing applicationTherapeutic and indication-specific development expertise across one or more therapeutic areas and one or more drug classes, including deep knowledge of clinical program and study design, relevant endpoints, safety considerations, and current regulatory and commercial landscapeThorough understanding of core cross-functional concepts (e.g., preclinical, translational medicine, CMC) and major program requirements at different development stagesDeep knowledge of important regulatory considerations and experience with FDA, EMA and other national regulatory authoritiesExperience as a medical strategy leader on one or more asset development teamsExperience with KOL and investigator interactionsStrong decision-making and analytical skillsExcellent communication and influencing skillsExcellent organizational skills and detail-orientated leadership approachFlexibility to travel domestically and internationallyAbility to work independently on multiple tasks in a fast-paced environmentEducation and ExperienceMD or equivalent with experience implementing therapeutic programs -Nephrology experience requiredSignificant experience contributing to product development team activities from early development through marketing application and/or launch to include 7+ years of pharmaceutical industry experienceExperience overseeing the design and execution of at least one full clinical program from first-time-in-human or proof of concept studies through submission of marketing applicationDirect experience with the creation and implementation of full asset development including pre-clinical, clinical, regulatory, CMC and (if applicable) biomarker strategy developmentThe salary range estimated for this position is $250,000 - $350,000. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer. -We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally includes: -A choice of national medical and dental plans, and a national vision planA wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HRAs) or Health Savings Account (HSA)Tax-advantaged savings and spending accounts and commuter benefitsEmployee assistance program -At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policyRetirement and savings programs, such as our competitive 401(k) U.S. retirement savings planWorking Conditions and EnvironmentWork is performed in an office environment with exposure to electrical office equipment.As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.Diversity StatementThermo Fisher Scientific is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. Thermo Fisher Scientific is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.COVID-19 Vaccination Update for U.S. Colleagues--- All U.S. colleagues are required to report vaccination status. New hires will be asked to report vaccination status within the first two weeks of employment.--- All U.S. new hires who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), remote site monitors-local (RSM-L) all CRA and RSM-L line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles. New hires will be asked to disclose vaccination status upon first day of employment and are required to report vaccination status within first two weeks of employment.

Keywords: PPD - Pharmaceutical Product Development, Bethesda , Exec Med Dir, Global Product Development (Nephrology), Other , Bethesda, Maryland