Total 3 job vacancies by Cerecin Pte. Ltd.

Cerecin is seeking a highly motivated and hands-on Medical Director to join our dynamic team. This role requires an individual who thrives in a collaborative environment and is deeply involved in day-to-day operational activities. The Medical Director will play a critical role in advancing our clinical development programs, contributing directly to protocol writing, scientific rationales, medical articles, and other essential documents.

Position Overview:

Provide leadership and direction for all clinical and regulatory activities, including preparation of clinical development plans, protocol design, and assessment of study results to meet commercial, regulatory, and scientific objectives. Provides expert advice regarding domestic and international regulatory submission requirements and strategies.

• Hands-On Leadership: Actively participate in the development of clinical strategies and ensure their execution through close collaboration with cross-functional teams.
• Medical Writing: Author and review key documents, including clinical protocols, investigator brochures, regulatory submissions, scientific rationales, publications, and white papers.
• Scientific Expertise: Provide medical insights that shape Cerecin’s clinical development programs and ensure alignment with the company’s mission to address unmet neurological needs.
• Clinical Oversight: Oversee clinical trials by providing medical guidance to ensure scientific rigor and compliance with regulatory standards.
• Stakeholder Engagement: Collaborate with internal teams, external partners, regulatory bodies, and key opinion leaders to advance Cerecin’s therapeutic pipeline

Position Responsibilities:

· Formulates and implements clinical strategies to enhance the marketability of the company’s products while ensuring strong interdepartmental collaboration.

· Directs and manages internal resources, external partners, consultants, contract research organizations (CROs), central laboratories, manufacturing, clinical trial packaging, IVRS vendors and other clinical research vendor’s participation in the conduct of clinical trials.

· Contributes to the development of clinical trial protocols; Works with the project team to develop appropriate timelines, budgets and resources to meet all trial objectives; Oversees execution of all clinical trial protocols, including investigator initiated trials.

· Participates in the assessment, qualification, and recommendation of clinical trial vendors (e.g., Contract Research Organizations [CROs], laboratories, etc.) and consultants.

· Manages and directs the preparation and establishment of Master Services Agreement and Work Orders with CROs, clinical research vendors, and other research professionals.

· Monitors progress of clinical trials and how they are conducted, recorded and reported versus the protocol, standard operation procedures (SOPs) good clinical practices and other applicable regulatory requirements and timelines.

· Develops and maintains budgets to support clinical trials, regulatory submissions, licenses and other regulatory and clinical activities.

· Prepares and presents summaries of clinical/regulatory status reports as required.

· Reviews clinical database management and statistical analysis plans to maintain data integrity and to ensure compliance with all applicable regulatory guidelines.

· In collaboration with clinical investigators, drafts, edits, and reviews clinical study manuscripts for publication in peer-reviewed journals.

· Encourages, develops, edits and reviews departmental and/or investigator publications in support of Cerecin products.

· Directs and participates in the preparation of regulatory documents, including but not limited to: Dossiers, Investigator Brochures, Clinical Study Reports, Package Inserts, promotional materials, and post-marketing safety reports as appropriate.

· Oversees outsourced Medical Information program for the company’s commercially available products to ensure the highest level of satisfaction for physicians, their patients, and caregivers.

· Oversees outsourced product safety program for the company’s commercially available products

· Reviews and updates product label copy, promotional and advertising materials and manuscripts for publication.

· Leads routine interactions with the FDA and international authorities on submission matters. Liaisons with marketing and sales force for appropriate advertising and promotional activities.

· Manages and provides recommendations regarding clinical/medical affairs department budgets and resource requirements.

· Manages direct reports including recommendations and justifications for staffing and training needs.

· Develops and maintains the Clinical and Regulatory Affairs infrastructure including all associated policies, procedures and standard operating procedures (SOPs) to optimized Clinical and Regulatory Affairs activities.

· Acts as medical monitor as required on clinical trials and reviews all medical data from clinical studies

· Represents the company at medical meetings, conferences, outreach meetings at key institutions, and in interactions with thought leaders.

· Maintains knowledge of disease areas within the company’s focus, stays current on leading edge products, development efforts and provides perspective to the business on the treatment landscape.

Experience Requirements:

· M.D. with minimum 3 year in clinical practice. Specialty training in Neurology a bonus

· Must have at least five (5) years experience managing a Clinical department at a Director level.

· It is strongly preferred to have a minimum of 10 years experience in clinical/medical/regulatory; coupled with 10 years of management experience. A minimum of 5 years managing direct reports is required.

· Expert knowledge of the biomedical industry, disease management, and industry trends

· Comprehensive knowledge of FDA and international agency guidelines; recent knowledge of China regulatory processes and guidelines is a bonus

· Adaptability to changing regulatory environment

Skill Requirements:

· Substantial previous management experience in clinical/regulatory/medical affairs

· Strong interpersonal/group skills with demonstrated ability to motivate and direct others

· Education, training, and/or demonstrated knowledge of Good Clinical Practice (GCP) and regulations/ guidelines/guidance/processes of relevant global regulatory authorities are required.

· Proficiency in supervising, managing performance and developing and mentoring individuals

· Innovative problem-solver who fosters collaboration with other project teams within the organization

· Excellent oral and written communication skills

· Detail oriented and dedicated to diligent follow-up through project completion

· Works independently with little or no supervision

· Computer proficient in applications including Word, Excel, and PowerPoint, etc.

Education Requirements:

· MD, MBBS or equivalent

Key Accountabilities

At the Project Level

§ Planning the Project: Defining the project’s scope, determining what resources are available/needed, estimating time and financial commitment, goals of the project,
intended outcome/deliverable(s), as well as how to monitor and report on the project’s progress (metrics).

§ Assembling and Leading the Project Team: Create team from available resources,
assign roles/functions/tasks to team members, ensure understanding and alignment on goals and deliverables, provide team members with parameters/expectations (in terms of time, cost and quality), ensure team members have necessary tools to
complete project and to collaborate, ensure communication within the team and without (to key stakeholders), and lead the team in all other ways to ensure success of the project.

§ Ensure integration amongst team members for overall project success: ensure
integration between the various functions (clinical, regulatory, CMC, non-clinical,
commercial, quality, finance, legal).

§ Budgeting Activities: Coordinating the development of aligned functional and project budgets, tracking actual spend.

§ Quality and Satisfaction: Ensuring quality delivery of project according to stakeholder expectations and communicating with stakeholders during the life cycle of the project.

§ Managing Issues and Risk: Predict, mitigate and manage risks. Implement and
manage change when necessary to meet project outputs.

§ Monitoring Progress: measure progress and compare against metrics determined in the planning stage. Adjust to keep project on track or to realign. Evaluate and assess result of project.

§ Reporting and Documentation: Present to stakeholders reports on progress as well as problems and solutions.

At the Portfolio level

§ Management and control of the delivery of multiple concurrent projects.

§ Delivery strategies which maximise project revenues, minimise costs, and ensure customer satisfaction.

§ Management of the full project life-cycle from beginning to end.

§ Determining the scope, deliverables and acceptance criteria for projects.

§ Obtaining stakeholder buy-in to project plans and programmes of change.

§ Plans and project timelines and milestones using appropriate planning tools.

§ Development of MS project plans and associated project documentation.

§ Working with resource managers, other departments and 3rd parties to identify and
schedule project resources.

§ Supervise and motivate resources involved in project deliveries in a matrix-management structure to ensure quality and consistency.

§ Tracking project costs so as to complete implementations within acceptable budget
tolerances.

§ Effective and regular communication with internal and external project stakeholders.

§ Delegation of tasks and responsibilities to appropriate personnel.

§ Resolution of issues and conflicts within projects.

§ Delivery of progress reports, proposals, requirements documentation, and presentations.

§ Ensuring project acceptance criteria and invoicing milestones are understood and agreed by the customer throughout project life cycle.

§ Proactively manage changes in project scope, identify and address issues, and devise
contingency plans.

§ Identification and management of project risks, dependencies, deliverables and milestones along a critical path.

§ Ensuring smooth transitions to business-as-usual at project completion.

§ Management of all financial aspects of the projects

§ Documentation and communication of project lessons to support a culture of constant learning.

§ Oversees strategic plan, monitoring and adapting as needed.

§ Maintains knowledge of larger landscape and strategy without neglecting granular details while tracking project health, staying alert for risk and resolving issues as they arise.

§ Maintains standards across projects.

§ Participate with senior leadership to establish strategic plans and objectives and
prioritization amongst projects.

§ Identify staffing needs/organizational changes as appropriate to meet company projects.

§ Work closely with heads of individual functions to ensure that each project is adequately resourced, budgeted and completed with required quality level.

Professional Experience

§ 10 years’ experience in biopharma as a cross functional program manager

§ Experience in strategic planning, risk management and change management

§ International biopharma experience

§ Neurology, CNS experience would be preferred

Skill Requirements

§ Proficiency in project management software tools (MS Project, Visio, Excel, etc.)

§ Proficiency in spoken and written English

§ Proficiency in MS Office software

§ Able to travel within Asia and globally

Education

§ BA/BSc degree in a relevant field

§ PMI certified (or equivalent)

The Director of Finance reports directly to the Chief Executive Officer (CEO) and holds both strategic and operational financial responsibilities. The Director of Finance will have a proven track record in biotech and public market entry, with direct experience in preparing for an initial public offering (IPO) and uplisting onto major exchanges such as NASDAQ. The Director of Finance will work alongside the CEO in planning, implementing, managing, and controlling all finance-related activities of the company. This includes direct responsibility for day-to-day accounting and finance needs, forecasting, strategic tax planning, compliance, corporate governance, and fundraising.

Key Accountabilities:

• Oversees and directs treasury, budgeting, audit, tax, accounting, shareholder ledger, investment, and insurance activities for the organization.
• The Director of Finance reports directly to the CEO and is also accountable to the Board of Directors, potentially receiving direct requests from the Board Chairman or the Head of Finance/Audit Committee.

Strategic/External Finance Role:

• Provides leadership in the development and execution of short- and long-term strategic financial goals, as well as an annual operating plan. Evaluates and develops financial and funding strategies that align with the company's objectives.
• Provides leadership in financial analysis of strategic partnerships and offers recommendations to enhance financial performance and business opportunities.
• Supports the CEO and executive team in preparing the company for an initial public offering (IPO) and entry into public markets. This includes leading the development of internal controls, policies, committees, and engagement with appropriate advisors.

Fundraising:

• Collaborates with the CEO and Investor Relations (IR) team to establish and maintain relationships with stockholders, financial institutions, and the investment community.
• Works with the CEO and management to develop budget forecasts and allocate funds for investors.
• Leads and manages all financial and corporate aspects of due diligence.
• Oversees and manages the closing of financings, including liaising with corporate counsel where necessary.

Internal Finance Role:

• Oversees all aspects of the Finance & Accounting team and its function within the organization.
• Reviews and approves payment of Accounts Payables, ensuring compliance with established policies. The incumbent has authority to sign bank checks/drafts and execute bank transfers.
• Appraises the organization's financial position and issues periodic financial and operating reports, including month-end and year-end financial statements. Oversees and directs the preparation and issuance of the corporation's Annual Report.
• Directs and coordinates the administration of budget programs. Analyzes, consolidates, and directs all cost accounting procedures along with other statistical and routine reports.
• Ensures the credibility and integrity of the Finance team.
• Ensures effective internal controls are in place and compliance with GAAP, as well as applicable federal, state, and local regulatory laws for financial and tax reporting.
• Provides the management team with support on client negotiations and advice on the financial implications of business activities.
• Responsible for providing and directing procedures and systems necessary to maintain proper records and ensure adequate accounting controls and services. This includes administering Financial Reporting Systems with controls and standards to safeguard company assets and ensure compliance with applicable accounting and auditing standards, as well as tax regulations. Coordinates the engagement and completion of the annual audit by the external auditor selected by the Board.
• Directs and analyzes studies of general economic, business, and financial conditions and their impact on the organization's policies and operations. Participates in the development of corporate strategic plans and objectives. Provides strategic financial guidance on issues such as the evaluation of potential alliances, acquisitions, and/or mergers.
• Manages the finance team and carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
• Responsible for general Corporate Administration, ensuring compliance with federal and state laws and regulations, as well as the Corporate Charter and Bylaws. Creates and maintains legal records of all corporate and Board actions, including Board meeting minutes, Board resolutions, Shareholder resolutions, and the cap table.

Requirements:

• At least a Bachelor in Accounting, Finance or related discipline
• CPA or MBA preferred
• Minimum 15 years of relevant work experience
• Prior experience in global life sciences/biotech/pharmaceutical MNCs preferred
• Prior experience with IPO and fundraising preferred
• Ability to have a big picture view while having attention to details
• Ability to maintain discretion and high-level of confidentiality
• Excellent verbal and written communication skills
• Excellent organisational skills and ability to multi-task
• Proficient in Microsoft Office (Word, Excel, Outlook and PowerPoint)
• Experience with Great Plains/Microsoft Dynamics preferred