Product Development Assistant Jobs in Groton, CT

The Global Development Lead (GDL) serves as the clinical representative on the Global Medicine Team, holding primary accountability for the clinical development of designated assets within Internal Medicine at our organization. This role involves leading a cross-functional Clinical Development Team, which includes professionals from clinical, clinical pharmacology, statistics, safety, commercial, patient access, and operations, to design, implement, and analyze studies that support global regulatory submissions.

The GDL is responsible for formulating and securing approval for the Clinical Development Plan and related protocol design documents. This individual acts as a vital collaborator with other clinical and operational colleagues throughout the lifecycle of studies for the assigned assets. Additionally, the GDL may engage with external partners in alignment with our Partner of Choice model and is expected to be an internal expert in their therapeutic area and clinical drug development.

Furthermore, the GDL may take on additional clinical leadership roles to support the Obesity portfolio, which could involve responsibilities related to trial design, execution, and reporting for other late-stage assets. Specific duties include:

• Providing specialized monitoring support as needed.
• Leading regulatory submission efforts and contributing to deliverables such as the SCE, SCS, and clinical overview.
• Offering insights for target product profiles and regulatory activities, including product labels, core data sheets, Investigator Brochures, Development Safety Update Reports, and Periodic Benefit-Risk Evaluation Reports.

• Collaborate effectively with the Medicine Team Lead to negotiate trade-offs, set milestones, and ensure the clinical program is delivered on time and within budget.
• Develop a comprehensive clinical development plan to achieve global approval and reimbursement, including creating pediatric investigation plans and associated protocol design documents while ensuring trial feasibility and operational efficiency.
• Provide product-specific insights for target product profiles.
• Encourage innovative thinking and decisive actions across clinical development programs and individual studies.
• Formulate clinical development strategies that incorporate digital innovation and patient engagement.
• Work with trial clinicians on governance reviews for assigned clinical studies, offering strategic input and insights.
• Provide expertise in therapy areas to support the clinical review of data, including CRF design and signal interpretation.
• Offer specialized medical monitoring support for trial teams as necessary.
• Contribute to trial-level statistical analysis plans and collaborate on database releases with statistics and programming teams.
• Develop submission-level deliverables and ensure compliance with safety narrative plans.
• Assist in the development and maintenance of product labels.
• Engage with external stakeholders, such as advisory boards and patient advocates, to generate strategic insights for clinical development and product development.
• Support regulatory submissions and ensure compliance with internal SOPs and external regulations.
• Review Investigator Initiated Research (IIR) proposals.

• Education: PhD or PharmD.
• Experience: A background in chronic weight management, endocrinology, or internal medicine, with experience in Phase 1-3 clinical development and translational medicine.
• At least 8 years of relevant experience with a proven track record in academia or the biopharmaceutical industry in clinical research and development.
• Extensive knowledge of clinical development processes, global and regional regulations, ICH/GCP guidelines, and adverse event management.
• Demonstrated capabilities in clinical/medical administration, project management, and effective communication with internal and external stakeholders.
• Experience in managing and training large teams in clinical development is preferred.
• Proven ability to influence and collaborate with peers, mentor others, and guide colleagues towards achieving significant outcomes.

• Medical/Scientific Credibility: A strong track record in pharmaceutical development, capable of coordinating and executing clinical strategies.
• Management Experience: Ability to navigate a complex matrix environment and influence cross-functional teams.
• Leadership: An effective and persuasive leader.
• Influencing Skills: Capable of motivating internal teams on clinical trials.
• Conflict Management: Able to mentor others in conflict resolution and view conflicts as opportunities for growth.
• Team Building: Fosters a collaborative environment, shares successes, and promotes team morale.
• Accountability: Takes personal responsibility for results and encourages others to exceed expectations.
• Change Agility: Maintains composure and effectiveness amidst organizational changes.

This position may require up to 30% travel. It is a hybrid role, necessitating residence within commuting distance and on-site work for an average of 2.5 days per week.

The annual base salary for this role ranges from $214,900 to $358,100. Additionally, this position is eligible for participation in our Global Performance Plan, with a bonus target of 22.5% of the base salary, as well as participation in our long-term incentive program. We offer a comprehensive benefits package designed to support the well-being of our colleagues, including:

• 401(k) plan with matching contributions and additional retirement savings contributions.
• Paid vacation, holidays, and personal days.
• Paid caregiver/parental and medical leave.
• Health benefits, including medical, prescription drug, dental, and vision coverage.

Relocation assistance may be available based on business needs and eligibility. Candidates must have authorization to work in the U.S. and sponsorship for work visas is not available for this role.

We are dedicated to providing equal employment opportunities to all individuals, regardless of race, color, religion, sex, sexual orientation, age, gender identity, national origin, disability, or veteran status. We comply with all applicable laws regarding nondiscrimination in employment and work authorization.