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VP of Clinical Development
Job Description
Job Summary: The Vice President of Clinical Development will report to the Chief Development Officer and be responsible for leading and managing the clinical development strategy from early clinical development to commercialization. The strong focus for this position is on Phase II through commercialization of products for the transplant and autoimmunity community. This role will require strong leadership, strategic planning, and cross-functional collaboration to ensure successful clinical trial execution and regulatory approval. This role also must be commutable to the NYC office. Responsibilities: Portfolio management and development strategy
- Develop and manage product profiles and Clinical Development Plans; lead the design, development, and implementation of innovative clinical trials, from translational stage through global Phase 3 trials and registration.
- Lead Clinical Development efforts with dynamic and creative but realistic approaches to drug development across multiple therapeutic areas and product modalities.
- Apply state-of-the-art knowledge of disease mechanisms to selection of possible biomarkers, pharmacodynamic endpoints, and patient stratification considerations to support innovative clinical study designs for novel products.
- Maintain the highest quality clinical programs, following GCP and ICH guidelines.
- Manage timely reporting of safety signals to regulatory authorities and the generation of clinical study reports.
- Lead clinical team to secure global regulatory approvals for pipeline products.
- Review documents including protocols, IBs, informed consent forms.
- Manage the writing of protocols, presentations, and publications (regulatory submissions, original articles, abstracts).
- Evaluate the balance between outsourcing and in-house approaches for the various Clinical Development needs and work closely with the VP Clinical Operations to make recommendations for the company’ strategy.
- Provide strategic consultation and guidance to Research on decisions that have significant clinical components and implications.
Cross-functional collaboration:
- Communicate regularly and effectively with senior leaders and across the R&D team
- Maintain accountabilities for all relevant timelines and deliverables.
- Collaborate closely with functional counterparts and colleagues to ensure tight strategic integration of product development plans across the Development function and to ensure coordination of these functions with Clinical Operations and Biometrics.
- Influence internal and external audiences in a high impact, highly visible way.
- Develops, inspires, and supports individuals and teams to perform at extraordinary levels and ensures that all are engaged, challenged, and committed. Promotes a culture of integrity and quality within the clinical development team and across the organization.
Requirements and qualifications:
- Medical Doctor (MD), or non-US equivalent of MD is required.
- Experience in clinical transplant or autoimmunity is required.
- Strong analytical skills with a demonstrated ability to think critically and creatively.
- 8+ years in Phase II – Phase III clinical development
- Ability to commute to the NYC office and/or ability to travel to NYC office
- Ability and willingness to travel domestically and internationally 20%
- Proven track record of successfully leading clinical development programs from Phase II through commercialization, including regulatory approvals.
- Must have and be able to demonstrate a commercial perspective
- Must have significant clinical development experience with a well-established track record of success across all phases of development.
- Demonstrated experience with positive and successful cross-functional collaboration with internal and external stakeholders
- Excellent communication and leadership skills; act as a player/coach with the willingness to “roll up the sleeves” to contribute to team efforts in a dynamic, fast-paced environment
- Outstanding writing skills with a track record of publications; superb presentation skills.
- Shows insightful thinking by developing creative approaches to processes and practices, products & solutions, services, business models & strategy.
- Significant regulatory experience with INDs, CTAs, End-of-Phase 2 meetings and NDA/BLAs/MAA, both US and ex-US.
- Experience having managed significant accelerations and challenges in clinical programs.
- Comfortable working with Senior Executive Team, Board members, KOLs, regulatory bodies, and investors.
- Experience working with biotech/pharma partner(s) and preferably prior membership of steering committees.
- Experience in both small and large biotech and/or pharmaceutical companies
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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