Job DescriptionThe PositionThe Executive Director, Asset Development Team (ADT) Program Leader (PL), Early Clinical Development & Translational Medicine (ECD & TM), will have accountability to lead a cross-functional ADT in the development of pipeline assets within the early clinical development space (pre-IND to proof-of-concept [PoC]).Responsibilities
She/he will guide the ADT to devise an integrated, efficient and strategic early development plan (EDP), including identification of key milestones, Go/No Go decision points and associated criteria, plan timelines and costs and is accountable for seeking governance approval thereof.
Within the context of established governance model, the ADT leader represents the ADT in discussions with governance bodies and functional leaders and ensures transparent and timely communication regarding changes to timelines and/or costs, issues significantly impacting approved plans and achievement of plan milestones to facilitate effective and informed decision-making and ensure budget reliability.
The ADT PL ensures plan assumptions, issues and plans to address, risks and mitigations, challenges and plans to overcome and development opportunities are identified and effectively, proactively and cross-functionally managed; the ADT PL recommends the formulation of sub teams or workstreams to address specific plan issues or challenges or manage cross-functional aspects of the plan.
The ADT PL works closely with the program manager (PM) to set agendas for team discussions and facilitates team discussions during ADT meetings.
The ADT PL ensures positive team dynamics, including respectful, professional and collaborative interactions, leading by example, to build trust amongst team members and cultivate the development of a high performing team, thereby optimizing team efficiency and effectiveness of plan execution and oversight.
The ADT PL ensures that functional representative roles and responsibilities, points of accountability, team behaviors and expectations for functional alignment are clear to ADT members.
She/He acts as “face of the program” towards the organization and ensures alignment between asset franchise strategy and program objectives and timelines.
The ADT PL ensures that the resources needed to support an approved plan are understood by the respective functional representatives, who are then responsible for ensuring functional alignment.
Required Education, Experience and Skills
Bachelor’s or Master's degree in a scientific, life science, or technical discipline required; an advanced degree (PhD, PharmD, MBA) is preferred.
Ten plus years in the pharmaceutical or biotechnology industry, with a minimum of 8 years of experience in program leadership and management or combined with a functional leadership position in early development.
In-depth understanding of the drug development process, from nonclinical development to product registration, post-approval requirements or commitments and life-cycle management with a working knowledge of non-clinical development, early- and late-stage clinical development, clinical operations, regulatory affairs, drug safety and pharmacovigilance, drug manufacturing and supply, market access, and commercial functions.
Specific experience in early clinical development and translational medicine with exceptional knowledge and understanding of early clinical development, translational medicine and clinical pharmacology principles and regulatory requirements.
Demonstrated experience in leading cross-functional or functional teams and effective management within a matrix organization, including multi-cultural, globally dispersed teams.
Demonstrated experience in effective interfacing and communication within all levels of a company and partners including C-Suite level executives.
Ability to think strategically and operationally with demonstrated ability to solve complex drug development and business-related challenges with significant ambiguity.
Adaptive leadership style, and ability to guide and influence cross-functional teams.
Highly collaborative orientation with outstanding communication and relationship-management skills.
Strong interpersonal and communication skills for bridging scientific and business constituents, negotiating objectives, deliverables, budget, and integrated timelines.
Strong analytical, organizational, problem-solving skills with strategic mindset and value-driven business acumen.
A ‘hands on’ attitude – comfortable diving into execution and operational matters, while maintaining focused on long-term strategy and objectives.
Who We Are:Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.US and PR Residents OnlyIf you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com .For more information about personal rights under Equal Employment Opportunity, visit:EEOC PosterEEOC GINA SupplementOFCCP EEO SupplementOFCCP Pay Transparency RuleOrganon proudly embraces diversity in all of its manifestations and 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, veteran status or any other characteristic protected by state or federal law.Search Firm Representatives Please Read CarefullyOrganon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Applicable to United States Positions Only: Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.Annualized Salary Range (US)$201,800.00 - $343,400.00Employee Status:RegularRelocation:No relocationVISA Sponsorship:Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.Flexible Work Arrangements:Remote WorkShift:Valid Driving License:Hazardous Material(s):Number of Openings:1Requisition ID: R524575
